[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Vrije Universiteit Brussel\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":691},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,34,0,25,[9,68,106,137,157,178,201,237,264,289,313,335,362,380,404,445,475,498,521,542,566,587,614,641,671],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100615555","phase-2-targeting-muscle-strength-loss-due-to-hospitalization-in-older-adults-by-blood-flow-restriction-combined-with-an-electromyography-driven-serious-game-100615555",false,"NCT07294131","Targeting Muscle Strength Loss Due to Hospitalization in Older Adults by Blood-flow Restriction Combined With an Electromyography-driven Serious Game.","Targeting Muscle Strength Loss Due to Hospitalization in Older Adults by Blood-flow Restriction Combined With an EMG-driven Serious Game","GHOSTLY+","PATIENTS\n\nInclusion Criteria:\n\n* Hospitalized, and expected to remain hospitalized for approximately 14 days\n* 65+ yrs\n* Unable to bear weight or transfer independently and at high risk of muscle strength loss due to prolonged immobility\n\nExclusion Criteria:\n\n* Contraindications for physical exercise as assessed by the treating physician using the risk assessment tool proposed by Kacin et al. (2015) (can be overruled by the physician)\n* Contraindications for blood flow restriction as assessed by the treating physician (can be overruled by the physician)\n* Cognitive impairment (MMSE score \\\u003C 19)\n* Any condition that renders the patient unable to understand instructions or safely interact with the GHOSTLY+ system\n\nTHERAPISTS\n\nInclusion Criteria:\n\nTherapists will be included if\n\n* They are licensed physiotherapists employed at one of the three participating clinical sites\n* They are involved in the daily rehabilitation of hospitalized older adults.\n\nExclusion Criteria:\n\nTherapists will be excluded from participation if\n\n* They are unable or unwilling to complete the GHOSTLY+ training\n* They are not directly involved in the care of eligible patients during the study period\n* They express any conflict of interest or ethical concern that may compromise the integrity of the study",true,"ALL","65 Years",{"count":22,"type":23},120,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","This study investigates a new training method designed to help older adults preserve their muscle strength during hospitalization. When older adults are admitted to the hospital and spend long periods in bed, their muscles can weaken very quickly. This condition is known as hospital-associated disability (HAD), and it can lead to longer hospital stays, reduced independence, and an increased risk of complications or even death. Conventional strength training with heavy weights is often too demanding or unsafe for frail patients, especially just after surgery or illness. As a safer alternative, this study combines light muscle exercises with a medically validated technique called blood flow restriction (BFR), which gently reduces blood flow to the leg to boost the effects of light exercises.\n\nTo make training more engaging and personalized, the GHOSTLY+ system was developed. This system consists of a game played on a tablet that responds to muscle activity through sensors placed on the skin. While playing, patients perform isometric muscle contractions (exercises where the muscles tighten without moving the joint) that help to maintain and rebuild strength. The system was carefully designed in collaboration with patients and therapists, and it has already been tested in a smaller pilot study at UZ Brussel.\n\nThe current study is a multicenter randomized controlled trial, taking place at UZ Brussel, UZ Antwerpen, and UZ Leuven. A total of 120 patients aged 65 or older will be recruited, all of whom are hospitalized and are unable to bear weight or transfer (e.g., from lying to seated position). Participants will be randomly assigned to one of two groups. One group receives standard physiotherapy. The other group receives standard therapy plus the GHOSTLY+ training program.\n\nThose in the GHOSTLY+ group will train at least five times per week for two weeks, or until discharge from the hospital. Each training session lasts approximately 30 minutes and involves three sets of 12 muscle contractions, guided by the game. The difficulty is adapted to the individual's muscle strength, which is measured at the beginning of the training using a built-in calibration protocol. During the session, a smart cuff is applied to the upper leg to partially restrict blood flow - a technique shown to safely enhance muscle adaptation. The cuff is inflated to 50% of the individual's arterial occlusion pressure and deflated after the session ends. Before beginning, participants receive a short training session with a physiotherapist. Our pilot study (Debeuf et al., 2025) shows that most patients can use the system independently after about one hour of instruction.\n\nMeasurements and evaluations take place at three timepoints: before starting the training, after one week, and again at discharge. The main goal is to assess leg muscle strength, which will be measured using a handheld device called a dynamometer. In addition, researchers will collect information on:\n\n* Muscle mass, via ultrasound of the thigh muscle\n* Functional capacity, using a 30-second sit-to-stand test and a walking scale (Functional Ambulation Category)\n* An index of independence in activities of daily living (Katz scale)\n* Cognitive functioning, using the Mini-Mental State Examination (MMSE)\n* Time spent bedridden and total length of hospital stay\n* Therapy adherence and user experience, via usage data and questionnaires\n* Muscle activity signals, such as fatigue, recorded during gameplay\n* Implementation outcomes (collected via surveys, interview, site logbooks)\n\nThe study will also assess how easily the GHOSTLY+ system can be implemented in real hospital environments. This includes evaluations of user satisfaction, therapist feedback, and how consistently the system is used across hospital settings. Information will be gathered through structured interviews, surveys, and data logs from the app. These insights are crucial to understanding whether GHOSTLY+ can be broadly adopted in other hospitals in the future.\n\nBlood flow restriction training is considered very safe when applied correctly and is already used in rehabilitation clinics and sports medicine worldwide. Over 300,000 sessions have been conducted internationally, with a very low rate of complications. Minor discomfort, such as temporary tightness or muscle fatigue, may occur, but the risk of serious side effects is extremely small.\n\nBy participating in this study, patients may benefit from improved muscle strength, reduced time spent in bed, and greater physical independence at discharge. The study also contributes to the development of more effective and enjoyable rehabilitation methods for older adults in hospitals.",[29,30,31],"Hospital Associated Disability","Immobility","Older Adults (65 Years and Older)",[33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,16],"hospital-associated disability","HAD","muscle strength loss","blood flow restriction","BFR","serious games","EMG-driven rehabilitation","geriatric rehabilitation","older adults","lower-limb strength","non-weight-bearing","randomized controlled trial","RCT","physical deconditioning","hospitalization","electromyography","digital rehabilitation","implementation science","rehabilitation technology","exergaming","inpatient rehabilitation","strength training","RECRUITING","2026-06-23",{"date":58,"type":59},"2026-06-26","ACTUAL",{"date":61,"type":59},"2026-06-05",{"date":63,"type":23},"2029-01-01",{"name":65,"class":66},"Vrije Universiteit Brussel","OTHER",3,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":18,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":24,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100642530","effects-of-physiotherapy-on-ultrasound-and-clinical-parameters-in-women-with-dysmenorrhea-100642530","NCT07645196","Effects of Physiotherapy on Ultrasound and Clinical Parameters in Women With Dysmenorrhea","Effects of Physiotherapy on Ultrasound and Clinical Parameters in Women With Dysmenorrhea With or Without Endometriosis","Inclusion Criteria:\n\n* female sex\n* aged 18 to 50 years\n* clinical diagnosis of dysmenorrhea (cyclic pelvic pain during menstruation)\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Delivery less than 1 year prior to enrollment\n* History of abdominal or pelvic surgery within the past 3 months\n* Diagnosis of fibromyalgia, diabetes, or cancer\n* Ongoing manual therapy treatment of the abdominal or genital area","FEMALE","18 Years","50 Years",{"count":79,"type":23},80,[81],"NA","Dysmenorrhea affects up to 90% of women of reproductive age and represents a significant public health concern. Beyond prostaglandin-mediated uterine contractions, dysmenorrhea involves central sensitization mechanisms and myofascial components, including abdominal trigger points. Despite growing interest in physiotherapy for chronic pelvic pain, objective data on tissue-level changes induced by manual therapy remain scarce.\n\nThis randomized single-blind sham-controlled trial aims to evaluate the effects of abdominal manual mobilization techniques on (1) tissue stiffness measured by shear wave elastography at the uterine cervix and bilateral abdominal regions, and (2) clinical outcomes including pain intensity and quality of life in women with dysmenorrhea, with or without endometriosis.\n\nParticipants will be randomly assigned to either a treatment group receiving standardized abdominal manual therapy or a sham group receiving superficial manual contact. Assessments will be conducted over three menstrual cycles using shear wave elastography, the Numeric Rating Scale (NRS), and the SF-36 questionnaire.",[84,85],"Dysmenorrhea","Endometriosis",[84,87,88,89,90,91,92,93,94,95],"endometriosis","Shear wave elastography","Manual therapy","Physiotherapy","Abdominal mobilization","Tissue stiffness","Chronic pelvic pain","Central sensitization","Menstrual pain","NOT_YET_RECRUITING","2026-06-08",{"date":99,"type":59},"2026-06-12",{"date":101,"type":23},"2026-09",{"date":103,"type":23},"2028-09",{"name":65,"class":66},2,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":18,"sex":19,"minAge":76,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":24,"phases":114,"briefSummary":116,"conditions":117,"keywords":122,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":4},"100639799","phase-1-investigating-central-contributions-to-fatigue-using-non-invasive-brain-stimulation-100639799","NCT07613970","Investigating Central Contributions to Fatigue Using Non-invasive Brain Stimulation","Investigating the Causal Contribution of Neural Oscillations to Neuromuscular Fatigue After Stroke Using tACS","Inclusion Criteria:\n\nFirst-ever stroke\n\n≥18 years Subacute phase: 1 week to 6 months post-stroke Quadriceps (hemiplegic side) strength ≤3\u002F5 (Medical Research Council (MRC)) Montreal Cognitive Assessment (MoCA) ≥21\n\nExclusion Criteria:\n\nHistory of a previous stroke Severe spasticity (Modified Ashworth Scale (MAS) 3-4 in quadriceps\u002Fhamstrings) Other neurological, motor, musculoskeletal, or orthopedic conditions affecting trunk stability and lower limb mobility Non-cerebral strokes (e.g., brainstem, cerebellar), or dementia (MoCA ≤20) Current or former athletes. Athletes are defined as individuals who participated in organized competitive sports and engaged in structured training ≥3 sessions per week for ≥1 year within the 5 years preceding stroke Contraindications for tACS (e.g., presence of a deep brain stimulator, pacemaker, head wound, etc.).",{"count":22,"type":23},[115,26],"PHASE1","The goal of this interventional study is to understand the contribution of the central components to the manifestation of neuromuscular fatigue in stroke survivors. The study will include adults with a first-ever stroke in the subacute phase.\n\nThe main question it aims to answer:\n\n• How does the brain activity contribute to the manifestation of neuromuscular fatigue in stroke survivors?\n\nResearchers will compare stroke participants receiving active vs sham tACS in a single session before the fatiguing contractions to determine whether central changes can influence fatigue onset\u002Fprogression.\n\nParticipants will:\n\n* Perform repeated leg muscle contractions until fatigue while seated in an experimental setup\n* Receive either active or sham tACS for 20 minutes before the fatiguing contractions.\n* Wear non-invasive sensors to record brain activity (EEG) and muscle activity (EMG) during the task\n* Complete the study during a single experimental session in which fatigue-related changes will be measured throughout the task",[118,119,120,121],"Stroke","Cerebrovascular Accident (CVA)","Ischemia Stroke","Hemorrhage Stroke",[123,124,125,48,126,127,128],"fatigue","electroencephalography","EEG","EMG","transcranial alternating current stimulation","tACS","2026-05-21",{"date":131,"type":59},"2026-05-29",{"date":133,"type":23},"2026-09-01",{"date":135,"type":23},"2029-10-31",{"name":65,"class":66},{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":18,"sex":19,"minAge":144,"maxAge":76,"enrollmentInfo":145,"targetDuration":4,"studyType":24,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":154,"leadSponsor":156,"locationsCount":105},"100638872","ultrasound-assessment-of-tongue-characteristics-in-adolescents-with-obesity-and-obstructive-sleep-disorders-100638872","NCT07613944","Ultrasound Assessment of Tongue Characteristics in Adolescents With Obesity and Obstructive Sleep Disorders","Standardised Ultrasound Assessment of Tongue Characteristics in Adolescents With Obesity and Obstructive Sleep Disordered Breathing: a Research Protocol","Inclusion Criteria:\n\n* Aged 12-18 years\n* Already enrolled in Zeepreventorium weight-loss program as Standard Care Diagnosed Obstructive Sleep Apnea (AHI ≥ 1)1 or any Obstructive sleep disordered breathing detected by any of the specific sleep questionnaire (OSA-18, ESS, SSS-Ad, PDSS)\n\nExclusion Criteria:\n\n* Any other orthopedic, traumatic, or rheumatologic condition affecting the cervicocephalic region\n* Syndromic or neuromuscular disorders\n* Cognitive impairment limiting compliance with study procedures\n* Inability to provide informed consent\n* Self-reported alcohol or recreational drug consumption within 48 hours preceding the experimental session","12 Years",{"count":79,"type":23},[81],"Obstructive sleep-disordered breathing, including obstructive sleep apnea (OSA), represents a significant yet underdiagnosed condition in the pediatric population, particularly among adolescents with obesity. The tongue is a central anatomical contributor to upper airway collapsibility; however, its biomechanical properties have been investigated almost exclusively in adult populations, leaving a critical gap in knowledge regarding younger individuals.\n\nThis study aims to assess tongue biomechanical and echographic characteristics using quantitative ultrasound modalities - shear-wave elastography (SWE), acoustic attenuation, and echo intensity - in adolescents aged 12 to 18 years with obesity and obstructive sleep disorders. The study adopts a mixed design combining (1) an observational cross-sectional comparison between participants with obesity and OSDB and age- and sex-matched healthy controls at baseline, and (2) a prospective longitudinal cohort component evaluating changes in tongue ultrasound characteristics over the course of a 30-week multidisciplinary inpatient weight-loss program delivered as standard care at the Zeepreventorium (De Haan, Belgium). An additionnal methodological objective consists in determining intra-rater and inter-rater reliability of the ultrasound acquisition protocol providing a reproducible framework for future studies.",[149,150,151],"Obesity & Overweight Sleep","Obstructive Sleep Disordered Breathing","Pediatric Obesity",{"date":131,"type":59},{"date":101,"type":23},{"date":155,"type":23},"2027-12-31",{"name":65,"class":66},{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":18,"sex":19,"minAge":76,"maxAge":4,"enrollmentInfo":164,"targetDuration":165,"studyType":166,"phases":4,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":176,"leadSponsor":177,"locationsCount":4},"100638548","studying-fatigue-and-movement-after-stroke-100638548","NCT07594938","Studying Fatigue and Movement After Stroke","Exploring Neuromuscular Fatigue in Stroke Survivors: Understanding Central-Peripheral Interaction","Inclusion Criteria:\n\nStroke survivors will be recruited from Brussels University Hospital (Brussels, Belgium). Patients who have a first-ever stroke, ≥18 years, subacute phase: 1 week to 6 months post-stroke, quadriceps (hemiplegic side) strength ≤3\u002F5 (Medical Research Council (MRC)), and Montreal Cognitive Assessment (MoCA) ≥21 will be included.\n\nExclusion Criteria:\n\nExclusion criteria include a history of a previous stroke, severe spasticity (Modified Ashworth Scale (MAS) 3-4 in quadriceps\u002Fhamstrings), other neurological, motor, musculoskeletal, or orthopedic conditions affecting trunk stability and lower limb mobility, non-cerebral strokes (e.g., brainstem, cerebellar), or dementia (MoCA ≤20), and current or former athletes. Athletes are defined as individuals who participated in organized competitive sports and engaged in structured training ≥3 sessions per week for ≥1 year within the 5 years preceding stroke. Control participants will be excluded if they meet the same exclusion criteria.",{"count":22,"type":23},"1 Day","OBSERVATIONAL","The goal of this observational study is to learn how neuromuscular fatigue develops after stroke and how changes in brain activity, muscle activity, and their interaction contribute to reduced motor performance in stroke survivors compared to healthy individuals. The study will include adults with a first-ever stroke in the subacute phase and age-matched healthy volunteers.\n\nThe main questions it aims to answer are:\n\n* How does neuromuscular fatigue develop during repeated muscle contractions after stroke compared to healthy individuals?\n* How do brain activity, muscle activity, and brain-muscle interaction change during fatigue after stroke?\n\nResearchers will compare stroke participants and healthy control participants to determine whether fatigue-related changes are more strongly associated with altered brain activity, altered muscle activity, or disrupted brain-muscle communication after stroke.\n\nParticipants will:\n\n* Perform repeated leg muscle contractions until fatigue while seated in an experimental setup\n* Wear non-invasive sensors to record brain activity (EEG) and muscle activity (EMG) during the task\n* Complete the study during a single experimental session in which fatigue-related changes will be measured throughout the task",[118,169,120,121],"Cerebro-vascular Accident",[123,124,125,48,126,171],"stroke","2026-05-18",{"date":174,"type":59},"2026-05-19",{"date":133,"type":23},{"date":135,"type":23},{"name":65,"class":66},{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":18,"sex":19,"minAge":76,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":24,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100636946","proof-of-concept-for-simulating-static-weight-bearing-exercises-in-the-supine-position-100636946","NCT07572292","Proof of Concept for Simulating Static Weight-bearing Exercises in the Supine Position","Validation and Evaluation of a Static Supine Weight-Bearing Computed Tomography Method to Enable Detection of Implant Migration After Knee Arthroplasty","SWB_PoC","Inclusion Criteria:\n\n* Healthy participants\n* Patients with TKA\n\nExclusion Criteria:\n\n* neurological conditions\n* acute trauma",{"count":187,"type":23},15,[81],"This project evaluates a new weight-bearing CT method to later improve early detection of implant migration after knee arthroplasty.\n\nThis method aims to allow patients to apply a controlled load during CT scanning, simulating standing conditions with real-time feedback.\n\nThe study has two phases. First, in healthy volunteers, biomechanical loading during prone simulated weight-bearing will be compared with a standard standing squat to validate the method. Second, in arthroplasty patients, standard radiographs will be compared with loaded and unloaded WBCT scans.\n\nPatients will not deviate from the standard plan of care. The CT images are additions to the standard RX images and are not intended for diagnostic purposes to the patient.\n\nThe aim is to determine whether this method opens the door for more accurate and earlier detection of implant migration than current clinical imaging in the future, potentially improving long-term outcomes after knee arthroplasty.",[191,192],"Knee Arthroplasty, Total","Healthy Participants","2026-05-04",{"date":195,"type":59},"2026-05-07",{"date":197,"type":23},"2026-05-01",{"date":199,"type":23},"2026-12-31",{"name":65,"class":66},{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":18,"sex":19,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":24,"phases":212,"briefSummary":213,"conditions":214,"keywords":218,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},"100621074","recognizing-emotional-neglect-and-help-seeking-intention-among-adolescents-in-brussels-100621074","NCT07365891","Recognizing Emotional Neglect and Help-Seeking Intention Among Adolescents in Brussels","Help-Seeking Behavior in Cases of Emotional Neglect: The Decision-Making Process of Adolescents in Dutch-Speaking Secondary Education in Brussels","Inclusion Criteria:\n\n* Age: adolescents aged 11-25 years;\n* Education: enrolled in regular full-time secondary education;\n* School location: Brussels-Capital Region;\n* School language: Dutch;\n* Consent: informed consent provided by the adolescent and their parent(s)\u002Fguardian.\n\nExclusion Criteria:\n\n* Age: younger than 11 years or older than 25 years;\n* Education: not enrolled in regular full-time secondary education;\n* School location: outside the Brussels-Capital Region;\n* School language: non - Dutch-speaking;\n* Consent: informed consent not provided by the adolescent or their parent(s)\u002Fguardian.","11 Years","25 Years",{"count":211,"type":23},500,[81],"The goal of this study is to find out how well adolescents in Dutch-speaking secondary schools in Brussels can recognize emotional neglect, and how this relates to their intention to seek help.\n\nThe main research questions are:\n\n1. How well do adolescents recognize situations of emotional neglect, and do boys and girls differ in their recognition?\n2. Does recognition of emotional neglect predict adolescents' intention to seek help?\n\nThis study is conducted through an online survey. Participants will read one of four short written stories about an adolescent experiencing emotional neglect. The stories vary by gender (boy or girl) and by the clarity of the neglect (clear or ambiguous). After reading, participants answer questions about the story, including their thoughts and how they might respond in a similar situation. They also answer questions about their own experiences and attitudes toward help-seeking.",[215,216,217],"Healthy Adolescents in School-based Population","Emotional Neglect","Help-Seeking Behavior",[219,220,221,222,223,224,225,226,227],"Help-seeking","Decision-making","Emotional neglect","Adolescents","Secondary education","Recognition","Help-seeking behavior","Child neglect","Child maltreatment and neglect","2026-04-27",{"date":230,"type":59},"2026-04-28",{"date":232,"type":59},"2026-02-23",{"date":234,"type":23},"2026-06",{"name":65,"class":66},1,{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":18,"sex":19,"minAge":76,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":24,"phases":246,"briefSummary":247,"conditions":248,"keywords":251,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":236},"100609303","the-added-value-of-transcranial-direct-current-stimulation-tdcs-during-exercise-for-people-with-chronic-widespread-pain-100609303","NCT07212829","The Added Value of Transcranial Direct Current Stimulation (tDCS) During Exercise for People With Chronic Widespread Pain","Unravelling the Epigenetic Mechanisms of Exercise-induced Pain in Chronic Widespread Pain: DNA Methylation Regulation of the Brain-derived Neurotrophic Factor Expression and Its Modulation by Transcranial Direct Current Stimulation","Inclusion Criteria:\n\nPatients\n\nParticipants in the patient group must meet all of the following criteria:\n\n1. Diagnosis of chronic widespread pain (CWP) or fibromyalgia;\n2. Age between 18 and 70 years old;\n3. Body mass index (BMI) ≤ 35;\n4. Widespread Pain Index (WPI) assessment: the WPI questionnaire (0-19 points) will be used to record the number and distribution of painful body sites. Participants will be classified as having CWP if pain is reported on both sides of the body, above and below the waist, and in the axial skeleton, with pain symptoms lasting ≥ 3 months;\n5. Stable medication use for at least 1 month prior to study entry.\n\nHealthy control group\n\nParticipants in the healthy control group must meet all of the following criteria:\n\n1. Age between 18 and 70 years old;\n2. Body mass index (BMI) ≤ 35;\n3. No chronic conditions, such as chronic pain and diabetes.\n\nExclusion Criteria:\n\nFor both patients and healthy controls, participants will be excluded if they meet any of the following:\n\n1. Current pregnancy or pregnancy within the past 12 months;\n2. Contraindications for non-invasive brain stimulation (NIBS), in line with published safety guidelines;\n3. History of neurological disorders, including epilepsy (personal or family history), traumatic brain injury, stroke, dementia, or Parkinson's disease;\n4. Major medical conditions, including cancer, endocrine or metabolic disorders, urine, genital and cardiovascu-lar diseases (e.g., myocardial infarction, heart failure, arrhythmia, uncontrolled hypertension).\n5. Substance abuse.\n6. Presence of psychiatric disorders other than depression or anxiety.","70 Years",{"count":22,"type":23},[81],"Many people with chronic widespread pain (CWP) feel more pain and fatigue after exercise. This makes it hard to stay active. Unfortunately, the investigators do not fully understand why this happens and how to prevent it.\n\nThe primary goal of this study is to explore the underlying genetic and epigenetic mechanisms of BDNF gene in response to exercise, and investigate if transcranial direct current stimulation (tDCS) during exercise works to improve worsening symptoms response to exercise in people with CWP.\n\nThe investigators designed a randomized crossover study and will enroll 60 patients with CWP and 60 healthy controls. Participants will undergo 2 interventions in random order: 1) exercise + active tDCS, and 2) exercise + sham tDCS. Participants will visit the hospital twice with at least one week in between the visits.",[249,250],"Chronic Widespread Pain","Fibromyalgia (FM)",[252,253,254,255],"BDNF","pain","exercise","DNA methylation","2026-04-14",{"date":258,"type":59},"2026-04-20",{"date":260,"type":59},"2026-02-01",{"date":262,"type":23},"2028-06-30",{"name":65,"class":66},{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":19,"minAge":76,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":24,"phases":274,"briefSummary":275,"conditions":276,"keywords":278,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":105},"100633739","evaluation-of-a-new-articulated-prosthetic-foot-comfort-safety-and-biomechanics-in-individuals-with-a-lower-limb-amputation-100633739","NCT07530601","Evaluation of a New Articulated Prosthetic Foot: Comfort, Safety and Biomechanics in Individuals With a Lower-Limb Amputation","Multidimensional Assessment of a New Ankle-Foot Prosthesis in Daily Use: User Comfort, Safety, and Biomechanical Performance","MAP-CSB","Inclusion Criteria:\n\n* Age: 18 - 80 years\n* Gender: Men and Women\n* Level of amputation:\n* Unilateral \u002F bilateral\n* Transtibial \u002F transfemoral \u002F knee disarticulation \u002F hip disarticulation\n* Cause of amputation:\n* Vascular, traumatic, cancer and congenital\n* Medicare Functional Classification Level: K2-K3-K4\n* Completion of post-amputation rehabilitation\n\nExclusion Criteria:\n\n* Any neurological disease\n* Excessive residual limb pain and wounds","80 Years",{"count":22,"type":23},[81],"This clinical investigation aims to evaluate a new articulated prosthetic foot during daily-life activities.",[277],"Lower-Limb Amputation",[279,280],"ankle-foot prosthesis","daily-life activities","2026-04-10",{"date":283,"type":59},"2026-04-15",{"date":285,"type":23},"2026-04",{"date":287,"type":23},"2027-06",{"name":65,"class":66},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":18,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":24,"phases":298,"briefSummary":299,"conditions":300,"keywords":302,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":312,"locationsCount":236},"100628372","development-of-serious-games-for-rehabilitation-a-delphi-study-100628372","NCT07460778","Development of Serious Games for Rehabilitation: a Delphi Study","Development of Serious Games for Rehabilitation, a Delphi Study","Inclusion Criteria:\n\n* Experience with (the development of) serious games for rehabilitation\n\nExclusion Criteria:\n\n* No experience with (the development of) serious games for rehabilitation",{"count":297,"type":23},30,[81],"This clinical study has been organised to identify the needs and recommendations of experts in the field of rehabilitation technology and gamification on the development of serious games for rehabilitation. Based on the information gathered we aim to construct a blueprint for the development of serious games for rehabilitation that maximizes clinical outcomes and the effective implementation in rehabilitation.",[301],"Expert Opinion on the Development of Serious Games for Rehabilitation",[303,304,305],"Delphi study","Serious games for rehabilitation","Rehabilitation","2026-03-04",{"date":308,"type":59},"2026-03-10",{"date":310,"type":23},"2026-03-01",{"date":133,"type":23},{"name":65,"class":66},{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":19,"minAge":320,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":24,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":236},"100620339","cognitive-model-for-behavioral-interventions-as-a-non-pharmacological-intervention-for-behavioral-and-psychological-symptoms-of-dementia-100620339","NCT07356336","Cognitive Model for Behavioral Interventions as a Non-pharmacological Intervention for Behavioral and Psychological Symptoms of Dementia","Examining the Efficacy of a Personalized Cognitive Model as Non-Pharmacological Intervention for Behavioral and Psychological Symptoms of Dementia","Inclusion Criteria:\n\n* Being a resident in a participating nursing home\n* Having a formal diagnosis of neurocognitive disorder (NCD) accord-ing to DSM-5-TR (e.g. Alzheimer's disease, NCD with Lewy Bodies, Vascular NCD, …) or a medical record indicating probable dementia\n* Presence of one or more BPSD symptoms at moment of inclusion in the study (measured with the NPI-Q at baseline). Symptoms measured by the NPI-Q include delusions, hallucinations, agitation\u002Faggression, depression\u002Fdysphoria, anxiety, euphoria\u002Felated mood, apathy\u002Findifference, disinhibition, irritability\u002Flability, aberrant motor behavior, nighttime behavior disturbances\u002Fsleep disturbances, and changes in appetite and eating behavior.\n* Primary caregivers (i.e. nurses providing daily care) and patient's representative and\u002For a close relative\u002Ffriend (i.e. informant who will fill in the premorbid personality questionnaire) are proficient in Dutch (i.e., are able to fill in the questionnaires)\n* The informant who fills in the premorbid personality questionnaire knows the patient well from before the onset of neurocognitive problems\n* As individuals with dementia are often legally incapacitated, informed consent will be obtained prior to participation from the resident when competent to consent, or otherwise from the resident's legal representative when legally incompetent.\n\nExclusion Criteria:\n\nExclusion criterion for nursing homes is:\n\n\\- Already applying a structured (theory-based) behavioral counseling as CAU.","60 Years",{"count":322,"type":23},60,[81],"The goal of this study is to evaluate whether the Cognitive Model for Behavioral Interventions (CoMBI), a person-centered, non-pharmacological intervention, can reduce behavioral and psychological symptoms of dementia (BPSD) in people with dementia living in nursing homes. The study also aims to examine whether CoMBI can reduce caregiver burden and improve quality of life in people with dementia.\n\nThe main questions it aims to answer are:\n\nDoes CoMBI reduce the severity of behavioral and psychological symptoms of dementia compared to care as usual?\n\nDoes a reduction in BPSD lead to lower caregiver burden and improved quality of life for people with dementia?\n\nDo personal factors, such as personality (dys)functioning, gender, level of cognitive impairment and stage of dementia, influence the effectiveness of CoMBI?\n\nResearchers will compare CoMBI to care as usual to determine whether CoMBI leads to better outcomes for people with dementia and their caregivers.\n\nParticipants will:\n\nReceive care in residential long-term care facilities where care staff are trained to apply CoMBI.\n\nBe observed and assessed repeatedly over time as part of a stepped-wedge cluster randomized trial design.",[326],"Behavioral and Psychological Symptoms of Dementia","2026-02-06",{"date":329,"type":59},"2026-02-11",{"date":331,"type":23},"2026-02-16",{"date":333,"type":23},"2028-12-31",{"name":65,"class":66},{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":18,"sex":19,"minAge":76,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":24,"phases":345,"briefSummary":346,"conditions":347,"keywords":349,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":359,"leadSponsor":361,"locationsCount":4},"100620584","implementation-and-evaluation-of-a-complex-intervention-to-reduce-avoidable-transitions-between-nursing-home-and-hospital-100620584","NCT07359521","Implementation and Evaluation of a Complex Intervention to Reduce Avoidable Transitions Between Nursing Home and Hospital","Implementation and Evaluation of a Complex Intervention to Reduce Avoidable Transitions Between Nursing Home and Hospital (RATHER-NH): Study Protocol for a Pilot Cluster Randomized Controlled Trial.","RATHER-NH","Inclusion criteria for nursing homes:\n\n* A capacity of at least 60 beds\n* Active engagement for the study from nursing home management, head nurses and the coordinating \\& advisory physician, meaning:\n\n  1. The nursing home manager, head nurses and the coordinating \\& advisory physician agree that the implementation of the RATHER-NH intervention is a priority for their facility.\n  2. The nursing home manager agrees to provide time for the nursing home staff members to participate in activities related to the implementation of RATHER-NH such as attending information sessions, training workshops, and feedback moments.\n  3. The nursing home manager is willing to allocate time to at least two nursing home staff members (each approximately 0.1 FTE for the study duration) to act as local project champions and to at least four other staff members (type of staff to be decided with the nursing home manager) to form a local action team to support the implementation and evaluation of RATHER-NH.\n\nExclusion criteria for nursing homes:\n\n* Already participated in another project designed to reduce potentially avoidable hospitalisations.\n* Already taking part in another major quality improvement initiative or study.\n* A large reorganisation or change in staff is taking place or is planned during the study period.",{"count":344,"type":23},12,[81],"Hospital admissions can have a negative impact on the physical and emotional health of nursing home residents. Although evidence-based interventions have been developed to reduce hospitalisations, the evidence regarding their effectiveness is inconclusive and challenges have been reported in implementing these interventions within the nursing home context. Hence, this study aimed to implement and evaluate a complex intervention to reduce avoidable transitions between nursing home and hospital (RATHER-NH).",[348],"Potentially Avoidable Hospitalisations",[350,351,352,353,354],"Nursing homes","Potentially avoidable hospitalisations","Quality improvement program","Implementation","Pilot cluster RCT","2026-01-13",{"date":357,"type":59},"2026-01-22",{"date":310,"type":23},{"date":360,"type":23},"2027-06-01",{"name":65,"class":66},{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":18,"sex":75,"minAge":76,"maxAge":4,"enrollmentInfo":369,"targetDuration":370,"studyType":166,"phases":4,"briefSummary":371,"conditions":372,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":379,"locationsCount":4},"100618923","altitude-training-effectiveness-is-there-a-role-for-sleep-and-menstrual-health-100618923","NCT07337928","Altitude Training Effectiveness; Is There a Role for Sleep and Menstrual Health?","FEMHEALTH","Inclusion Criteria:\n\n* Healthy\n* Female\n* Elite cyclist\n\nExclusion Criteria:\n\n\\-",{"count":297,"type":23},"6 Months","Therefore, the present study aims to evaluate the role of the impact of altitude on sleep and the menstrual cycle in the inter- and intraindividual variability of altitude training effectiveness. In order to do so, elite female cyclists will be monitored before, during and after an altitude training camp. The monitoring will include menstrual cycle characteristics, sleep and altitude effectiveness and will start three months before the start of the altitude training camp and end two months after the altitude training camp. Both naturally cycling women and women using contraceptives will be included in the study. Menstrual cycle monitoring will take place via self-reports and via a daily saliva (Eli Health) and urine (Proov) test to measure progesterone concentration. Besides proges-terone concentration, the sampled urine will also be used to perform an ovulation test on (i.e., measuring the luteinizing hormone). In addition, a blood sample will be collected at the start of each menstrual cycle to evaluate the concentration of menstrual cycle-related hormones (e.g., fol-licle-stimulating hormone, luteinizing hormone, estrogen, and progesterone) and to evaluate the functioning of the Hypothalamic-Pituitary-Adrenal Axis (i.e., cortisol concentration). Sleep moni-toring will be performed via the use of questionnaires, actigraphy and polysomnography. Lastly, altitude effectiveness will be evaluated via the altitude-associated response in total hemoglobin mass and via an all out cycle ergometer task.",[373],"Altitude Effectiveness","2026-01-06",{"date":355,"type":59},{"date":377,"type":23},"2026-02",{"date":234,"type":23},{"name":65,"class":66},{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":18,"sex":19,"minAge":76,"maxAge":386,"enrollmentInfo":387,"targetDuration":4,"studyType":24,"phases":388,"briefSummary":389,"conditions":390,"keywords":392,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":403,"locationsCount":236},"100617837","monitoring-the-effect-of-mental-fatigue-on-physical-performance-using-wearable-sensors-and-physiological-parameters-100617837","NCT07323810","Monitoring the Effect of Mental Fatigue on Physical Performance Using Wearable Sensors and Physiological Parameters","Inclusion Criteria:\n\n* Healthy (no neurological, cardiovascular or musculoskeletal disorders of any kind)\n* Male or female\n* No prior knowledge of the concept of MF\n* No medication\n* Non-smoker\n* 18-35 years of age\n* Experienced runners: (≥15km\u002Fweek and\u002For ≥2u\u002Fweek during the last 6 months)\n\nExclusion Criteria:\n\n* Injuries in the past 6 months, affecting running performance\n* Suffering from a chronic health condition (could be neurological, cardiovascular, internal or musculoskeletal)\n* Participating in any concomitant care or research trials\n* History of suffering from any mental\u002Fpsychiatric disorders\n* Use of medication\n* Use of caffeine and heavy efforts 24 hours prior each trial\n* Suffering from colour vision deficiencies\n* Not eating a standardized meal, the morning of each trial and the evening before each trial","35 Years",{"count":297,"type":23},[81],"Mental fatigue (MF) negatively affects both cognitive and physical performance, increasing the risk of errors in high-stakes environments such as sports and surgery. Traditional methods to assess MF rely on subjective self-report scales, which are prone to bias, or on complex brain measurements (e.g. EEG) that are impractical outside laboratory settings. This study aims to develop a real-time, objective monitoring method for MF using wearable physiological sensors. The study will recruit healthy, trained runners (18-35 years old) who will complete both an MF-inducing cognitive task (Stroop test) and a control condition (watching a documentary) in a randomized, counterbalanced, crossover design. Heart rate variability, respiration rate, and pupil metrics will be continuously recorded using wearable devices. Machine learning models will be used to predict MF-level as well as the effect of MF on physical performance (5-km time trial on a treadmill) using the physiological data as input.",[391],"Mental Fatigue",[393,394,395,396],"Fatigue","Performance","Physiology","Wearables","2025-12-22",{"date":399,"type":59},"2026-01-07",{"date":401,"type":23},"2026-01",{"date":234,"type":23},{"name":65,"class":66},{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":18,"sex":19,"minAge":76,"maxAge":320,"enrollmentInfo":412,"targetDuration":4,"studyType":166,"phases":4,"briefSummary":413,"conditions":414,"keywords":418,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":236},"100590931","studying-the-neurobiological-mechanisms-of-non-specific-chronic-low-back-pain-and-chronic-insomnia-a-four-group-cross-sectional-study-100590931","NCT06973837","Studying the Neurobiological Mechanisms of Non-specific Chronic Low Back Pain and Chronic Insomnia: a Four-group Cross-sectional Study","Unravelling the Neurobiological Mechanisms Underlying the Bidirectional Relationship Between Chronic Sleep Disturbances and Pain Sensitivity in People With Non-specific Chronic Low Back Pain and Chronic Insomnia","SY-NAPS-CS","General inclusion criteria (all groups):\n\n* 18-60 years old.\n* Ability to speak and understand the Dutch Language.\n* Body mass index \\\u003C30.\n* No smoking or nicotine use.\n* Low caffeine use (≤3 cups of coffee\u002Fday, ≤1 energy drink\u002Fday).\n* Low alcohol use (≤9 alcoholic units\u002Fweek).\n* No use of neuro- and\u002For psychopharmacological treatments and\u002For immunosuppressive agents (including NSAIDs) with a suspected influence on neuroinflammation unless terminated within a sufficient time frame before the start of the study, or unless falling under the Pharmacological exceptions criteria (see below).\n* Willing to (try to) adhere to the acute pre-test restrictions, including refraining from analgesics (unless stable use), caffeine, alcohol, and\u002For strenuous physical activity (\\>3 METs) in the 24 hours preceding the main test day.\n\nGeneral exclusion criteria (all groups):\n\n* Shift worker.\n* Use of blood thinners.\n* (History of) Substance dependence\u002Fabuse.\n* Chronic pain conditions (≥3 months) other than chronic low back pain.\n* Severe intrinsic sleep disorders (assessed during a one-night, laboratory-based polysomnography).\n* Restless leg syndrome\n* Central or peripheral neurological disorder\u002Fcondition (e.g., epilepsy, multiple sclerosis, peripheral neuropathy).\n* History of spinal surgery.\n* Major medical (e.g., cardiac disease, cancer) and\u002For psychiatric disorder\u002Fdisease (e.g., major depressive disorder, bipolar disorder).\n* Claustrophobia.\n* Contraindications for magnetic resonance imaging (e.g., metal\u002Fcochlear implants, pacemaker).\n* Pregnancy or being \\\u003C12 months post-natal.\n\nPharmacological exceptions criteria:\n\n\\- Participants with chronic low back pain and\u002For (comorbid) insomnia will be allowed to be on a stable low dose of weak pain and\u002For sleep agents (e.g., Tramadol, Zolpidem) if medically prescribed specifically for their low back pain and\u002For insomnia, and if approved by the national medicine register of Belgium (FAMHP, Federal Agency for Medicine and Health Products). These participants will also be allowed stable and\u002For occasional use of low-to-moderate doses of over-the-counter medications for pain and\u002For sleep that are suspected to have no or minimal impact on neuroinflammation (e.g., paracetamol, melatonin). Habitual use of medications according to the above-stated criteria should be maintained across the entire study period, with the only exception being analgesics taken on an occasional basis. Specifically, because of the extensive battery of pain tests that will be utilized in the study, all analgesics that are only taken occasionally should be refrained from during the 24 hours preceding the main test day (pre-test instructions).\n\nSpecific inclusion criteria for \"pain-free\" groups:\n\n* Currently pain free, defined as having no pain that affects daily living\u002Ffunctioning and\u002For which has led to a consultation with a healthcare practitioner.\n* No episode of low back pain that interfered with daily functioning\u002Fliving and\u002For which led to a consultation with a healthcare practitioner within 12 months from the time of inclusion.\n* No history of chronic low back pain.\n\nSpecific inclusion criteria for \"chronic low back pain\" groups:\n\n* Low back pain reported on most days (≥50%), every week, for more than 3 months.\n* Low back pain-related emotional disress OR functional disability rated as ≥3 out of 10.\n\nSpecific inclusion criteria for \"good sleeper\" groups:\n\n* Stable sleep phase within 10 PM and 10 AM (assessed using the Pittsburgh Sleep Quality Index).\n* Average habitual total sleep time between 7 and 9 hours (assessed using the Pittsburgh Sleep Quality Index).\n* A Pittsburgh Sleep Quality Index ≤5.\n* An Insomnia Severity Index ≤7.\n* An Epworth Sleepiness Scale ≤10.\n* Sleep efficiency ≥85% during a one-night, laboratory-based polysomnography screening.\n* No episode of sleep disturbances that interfered with daily functioning\u002Fliving and\u002For which led to a consultation with a healthcare practitioner within the preceding 12 months from the time of inclusion.\n* No history of chronic insomnia.\n\nSpecific inclusion criteria for \"chronic insomnia\" groups:\n\n* Chronic insomnia according to the ICSD-3-TR criteria (assessed using an ICSD-3-TR-adapted version of the Pittsburgh Sleep Quality Index).\n* An Insomnia Severity Index ≥15.",{"count":79,"type":23},"This study is a part of a larger project aiming to evaluate the neurobiological mechanisms underlying the relationship between sleep and pain in people with non-specific chronic low back pain. Specifically, this study aims to evaluate the neurobiological mechanisms underlying the relationship between chronic sleep disturbances and pain sensitivity in people with non-specific chronic low back pain and chronic insomnia.",[415,416,417],"Chronic Low Back Pain (CLBP)","Chronic Insomnia","Neuroinflammation",[419,420,421,422,423,424,425,426,427,428,429,430,431,432,433,434,435,436],"Pain","Chronic pain","Chronic low back pain","Sleep","Insomnia","Chronic insomnia","Magnetic resonance imaging","Functional magnetic resonance imaging","Magnetic resonance spectroscopy","Diffusion weighted imaging","Quantitative sensory testing","Temporal summation","Conditioned pain modulation","Experience sampling method","Ecological momentary assessment","Microbiota","Gut-Brain axis","Short-chain fatty acids","2025-12-06",{"date":439,"type":59},"2025-12-15",{"date":441,"type":59},"2025-10-03",{"date":443,"type":23},"2026-10",{"name":65,"class":66},{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":18,"sex":19,"minAge":76,"maxAge":20,"enrollmentInfo":452,"targetDuration":165,"studyType":166,"phases":4,"briefSummary":454,"conditions":455,"keywords":457,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":4},"100611086","training-and-testing-database-for-imu-based-gait-analysis-methods-100611086","NCT07236008","Training and Testing Database for IMU Based Gait Analysis Methods","IMU-GAIT","Inclusion Criteria:\n\n* Healthy subjects with no motor impairments that disrupt the walking pattern.\n* No history of pain in the lower limbs in the past 6 months.\n* No history of lower limbs injuries\u002Fsurgeries in the past 6 months.\n* Language: Dutch and\u002For English and\u002For French speakers.\n* Age 18-65 years old\n* Subjects must be able to understand the instructions and to answer questions. Additionally, they should be able to; signal pain, fear, discomfort; give inform consent.\n\nExclusion Criteria:\n\n* Persons with comorbidity that could hinder the study (e.g.: unstable cardiovascular system disorders, lung disorders, severe osteoporosis).\n* Individuals with metal implants or skin conditions that would make sensor or marker placement difficult.",{"count":453,"type":23},150,"The goal of this study is to establish a high-quality, synchronised dataset of gait events (GE) by simultaneously collecting inertial measurement unit (IMU) data and validated ground truth detections using a Vicon motion capture system. The primary objective is to address existing limitations in GE detection - such as poor generalisability, limited data diversity, and lack of precise synchronisation - through a rigorous protocol that ensures accuracy and transparency. The experiment is structured in three phases. First, Vicon-derived GE will be validated and refined using complementary modalities (force plates and video recordings). Next, deep learning (DL) algorithms will be developed and evaluated for GE detection directly from IMU data, with Vicon annotations serving as ground truth. Finally, the impact of differences in GE timing on spatiotemporal gait parameters (SGP) will be analysed to assess the feasibility of using IMU-only systems for reliable gait analysis.\n\nBy achieving these objectives, the study aims to improve the accuracy of GE detection from wearable sensors and enable more accessible, scalable, and reliable gait analysis outside the laboratory environment.",[456],"Healthy Subjects or Volunteers",[458,459,460,461,462,463,464,465,466],"Gait analysis","Gait events","Spatiotemporal gait parameters (SGP)","Inertial measurement units (IMU)","Wearable sensors","Motion capture (Vicon)","Deep learning","Machine learning","Healthy adults","2025-11-17",{"date":469,"type":59},"2025-11-19",{"date":471,"type":23},"2025-12-01",{"date":473,"type":23},"2029-12-31",{"name":65,"class":66},{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":19,"minAge":76,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":166,"phases":4,"briefSummary":483,"conditions":484,"keywords":487,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":497,"locationsCount":236},"100580240","clinical-outcomes-of-continuous-positive-airway-pressure-treatment-in-people-with-obstructive-sleep-apnea-and-chronic-pain-100580240","NCT06834724","Clinical Outcomes of Continuous Positive Airway Pressure Treatment in People With Obstructive Sleep Apnea and Chronic Pain","Clinical Outcomes of Continuous Positive Airway Pressure Treatment in People With Obstructive Sleep Apnea","Inclusion Criteria:\n\n* Participants must be 18 years of age or older\n* Participants must be able to read and write in Dutch, French or English\n* Participants must be diagnosed with clinically relevant OSA and newly start CPAP treatment:\n* AHI ≥ 15\n* Prescribed CPAP for the first time as a treatment for their OSA\n* Participants must have read and signed the ICF\n\nExclusion Criteria:\n\n* Participants who are currently receiving CPAP treatment or have had a CPAP treatment in the last year\n* Participant receiving CPAP for other conditions than OSA (e.g. Central Sleep Apnoea)",{"count":79,"type":23},"The bidirectional link between sleep and pain is a widely accepted concept. While there has been much focus on this in recent years, studies investigating obstructive sleep apnoea (OSA) and chronic pain are still not very common, especially in context of continuous positive airway pressure (CPAP) therapy.\n\nIn this study, people recently diagnosed with OSA, a common sleep disorder, that are receiving a CPAP mask are asked to fill in questionnaires at baseline, 3- and 6-month follow-up. Data of people with and without chronic pain will be collected and we will use the data will allow us to answer a number of clinically relevant questions. The primary questions investigate the following: 1) The association of CPAP adherence and pain outcomes with CPAP therapy at 3-month follow-up; 2) The association of baseline Apnoea-Hyopnea-Index on pain outcomes with CPAP therapy at 3-month follow-up. Secondary questions investigate the relevance of co-morbid insomnia (COMISA), the influence of chronic pain on CPAP adherence and general clinical outcomes of CPAP therapy in people with chronic pain.",[485,486],"Chronic Pain","Obstructive Sleep Apnea",[420,488,489,490],"Obstructive sleep apnoea","Obstructive sleep apnea","CPAP","2025-09-22",{"date":493,"type":59},"2025-09-26",{"date":495,"type":59},"2025-03-10",{"date":285,"type":23},{"name":65,"class":66},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":19,"minAge":76,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":24,"phases":508,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":105},"100551126","pilot-testing-a-perinatal-palliative-care-intervention-program-100551126","NCT06456034","Pilot-testing a Perinatal Palliative Care Intervention Program","Testing a Perinatal Palliative Care Intervention Program Within Standard Perinatal Healthcare: Pilot Testing Protocol","PPC-pilot","Inclusion Criteria:\n\n* Parents:\n\n  * who receive a severe foetal diagnosis for their unborn child and decide to continue the pregnancy after 20 weeks of gestation , or\n  * who receive a severe foetal diagnosis for their unborn child after 20 weeks gestation and decide to terminate the pregnancy (with or without feticide) resulting in the stillbirth of their child\n* Parents who receive a severe neonatal diagnosis for their live-born infant in the first week after birth\n\nAdditional inclusion criteria for parents:\n\n* Parents are either Dutch speaking, or are willing to participate with support from a (phone or real life) interpreter, in collaboration with the \"Agentschap Integratie \\& Inburgering\"\n* Parents are older than 18\n* Parents are not suffering from an officially diagnosed psychiatric disorder prior to receiving the severe diagnosis of their child\n* Parents are deemed (emotionally) approachable for the current study by the treating physician\n\nFor each family included in the pilot study, the physicians and nurses\u002Fmidwives who will be\u002Fare most closely involved in the care of the infant and the parents will also be asked to participate. If healthcare providers refuse to provide informed consent to participate in the study, their data will be deemed as missing for that case (parental outcomes are considered as the primary outcome measures).",{"count":507,"type":23},20,[81],"The objective of this pilot trial is to implement a new perinatal palliative care intervention program tailored to the Flemish context, which aims to provide care to parents who receive a severe foetal\u002Fneonatal diagnosis for their (unborn) child and to their healthcare providers. Additionally, we aim to evaluate the feasibility and preliminary effectiveness by comparing measured variables to the baseline measurement done in the same hospital wards beforehand.",[511,512,513],"Perinatal Palliative Care","Life-limiting Fetal Diagnosis","Life-limiting Neonatal Diagnosis","2025-09-16",{"date":491,"type":59},{"date":517,"type":59},"2025-05-18",{"date":519,"type":23},"2025-12",{"name":65,"class":66},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":19,"minAge":76,"maxAge":20,"enrollmentInfo":529,"targetDuration":4,"studyType":24,"phases":531,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":105},"100501620","lifestyle-intervention-in-overweightobese-chronic-low-back-pain-clbp-patients-an-international-multi-center-rct-100501620","NCT05811624","Lifestyle Intervention in Overweight\u002FObese Chronic Low Back Pain (CLBP) Patients: an International Multi-center RCT","Lifestyle Intervention in Overweight\u002FObese People Suffering From Chronic Low Back Pain: an International Multi-center Randomized Controlled Trial","BO2WL","Inclusion Criteria:\n\n* Adults (18 - 65 years)\n* Overweight (BMI ≥ 25 kg\u002Fm2) or obese (BMI ≥ 30 kg\u002Fm2) women and men.\n* CLBP (n=252), which is defined as nonspecific low back pain for at least 3 months duration, currently seeking care for low back pain and leg pain not ≥ 7 (on a maximum of 10) on a numeric rating scale.\n* Continue usual care 6 weeks prior to (to obtain a steady stat) and during study participation.\n* Depending on the country of inclusion: Native Dutch speaker (for Belgium) or Native German speaker (for Switzerland).\n\nExclusion Criteria:\n\n* Patients with BMI ≥ 40 kg\u002Fm² will be excluded as people being morbid obese are eligible to undergo abdominal surgery. Because BMI may not always correspond to the same body fat percentage in different individuals (e.g., athletic types with higher muscle mass may also have BMIs ≥ 25 km\u002Fkg²), each participant's body fat percentage will be measured using the TANITA and compared to the body fat percentage reference values. Participants with exceeding BMI but falling into the healthy fat percentage range (which is sex-, age- and ethnicity dependent will be excluded.\n* Pregnant, currently breastfeeding or given birth in preceding year.\n* Currently receiving dietary or exercise interventions or received in the past 6 weeks.\n* Show evidence of specific spinal pathology based on self-report (e.g., hernia, spi-nal stenosis, spondylolisthesis, infection, spinal fracture or malignancy), or a se-vere underlying comorbidity specific diagnoses that interfere with treatment (e.g., diagnosed diabetes, cardiovascular problems, metabolic diseases)\n* Other severe diseases based on current medication intake or being currently treated by a medical doctor for a specific diagnosis, (e.g. diagnosed eating disorders).\n* Ongoing problems or cases with insurance companies regarding their back.",{"count":530,"type":23},252,[81],"Chronic low back pain (CLBP) is the most expensive cause of workrelated disability: it causes the highest number of years lived with disability. The most severe and debilitated CLBP patients often have comorbidities such as overweight and obesity. Despite the growing body of scientific literature pointing towards the close interaction between overweight\u002Fobesity and CLBP, few treatment programs for people with CLBP nowadays take overweight into account. Therefore this study will examine the added value of a behavioral weight reduction program (changes in diet, behavior and physical exercise) to current best evidence rehabilitation (pain neuroscience education plus cognition-targeted exercise therapy) for overweight or obese people with CLBP. An international, multicenter randomized controlled trial comparing a behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy versus pain neuroscience education and cognition-targeted exercise therapy alone, will be conducted. The primary outcome is pain and the primary endpoint was chosen at 12 months follow-up; secondary outcomes include health care use and daily functioning (see detailed description of outcomes for an overview of all secondary outcomes). If the promising results of the proof of concept study are corroborated, the new intervention will have a high socio-economic impact, including an annual health care cost reduction of €66 million in Switzerland, and €60 million in Flanders, and is expected to increase life expectancy in the long term.",[534,535],"Overweight or Obesity","Chronic Low-back Pain",{"date":491,"type":59},{"date":538,"type":59},"2023-04-13",{"date":540,"type":23},"2026-11",{"name":65,"class":66},{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":18,"sex":19,"minAge":549,"maxAge":144,"enrollmentInfo":550,"targetDuration":4,"studyType":166,"phases":4,"briefSummary":552,"conditions":553,"keywords":555,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":565,"locationsCount":236},"100602218","pain-and-sleep-disturbances-in-children-living-beyond-cancer-a-case-control-study-100602218","NCT07120646","Pain and Sleep Disturbances in Children Living Beyond Cancer: A Case-Control Study","The Co-Morbidity of Pain and Sleep Disturbances in Children Living Beyond Cancer: A Case-Control Study","Inclusion Criteria:\n\n* CBC: 1) current age 6-12yo; 2) history of any cancer diagnosis; 3) ≤ 5y post- treatment completion; 4) ≥ 3 months since last cancer treatment (since pain and insomnia during treatment can be directly related to therapy and recover spontaneously); 5) fluent Dutch speaker and reader (age-dependent)\n* Healthy controls (age- and sex-matched): 1) current age 6-12yo; 2) no history of cancer ; 3) fluent Dutch speaker and reader (age-dependent)\n* Parents: 1) fluent Dutch speaker and reader\n\nExclusion Criteria:\n\n* CBC: 1) receiving palliative therapy; 2) psychiatric disorder; 3) severe intellectual disability\n* Healthy controls: 1) history of cancer; 2) psychiatric disorder; 3) severe intellectual disability","6 Years",{"count":551,"type":23},76,"Children living beyond cancer (CBC) represent a unique and growing population of young people in need of long-term clinical support. Studies suggest that 11-44% of CBC experience chronic pain, negatively impacting a wide range of child biopsychosocial outcomes and creating high financial burden for their families and society. Often comorbid with pain, one of the most chronic and disturbing side effects reported by CBC are sleep disturbances, and in particular, difficulties initiating and maintaining sleep. Indeed, \\>50% of CBC report some form of sleep disturbance even 9 to 15 years after the cancer diagnosis. Much attention has been paid to sleep and pain as independent constructs within pediatric oncology, yet Belgian data is lacking. Additionally, little is known about how these domains interact with one another and subsequent indications for prevention and intervention. Although evidence shows an interrelationship between pain and sleep in adult and pediatric populations, this interrelationship is understudied in childhood cancer patients and CBC. (Chronic) pain may serve as a modifiable target for interventions to improve sleep quality and vice versa, and understanding this relationship is crucial for providing comprehensive care to CBC. Therefore, this cross-sectional case-control study aims to explore the differences in pain and sleep disturbances in CBC compared to healthy age- and sex-matched healthy controls, as well as the interrelationship between both outcomes.",[554],"Childhood Cancer Survivors",[556,253,557,558],"children living beyond cancer","sleep disturbances","case-control","2025-08-11",{"date":561,"type":59},"2025-08-13",{"date":563,"type":23},"2025-08",{"date":234,"type":23},{"name":65,"class":66},{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":18,"sex":19,"minAge":76,"maxAge":386,"enrollmentInfo":573,"targetDuration":4,"studyType":24,"phases":575,"briefSummary":577,"conditions":578,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":236},"100506896","phase-3-the-role-of-the-brain-in-mental-and-physical-fatigue-100506896","NCT05880342","The Role of the Brain in Mental and Physical Fatigue","Investigating Fundamental Mechanisms of Mental and Physical Fatigue Using Neurotransmitter Reuptake Inhibitors and Electroencephalography: a Randomized Counterbalanced Crossover Trial","Inclusion Criteria:\n\n* Healthy trained individuals (exercises at least 1x per week, no neurological, cardiovascular internal or musculoskeletal disorders of any kind)\n* No use of chronic or occasional prescribed medication (except for contraceptives)\n* Non-smoker\n\nExclusion Criteria:\n\n* Injuries of any kind in the past 6 months\n* Pregnancy\n* Specific food or drink allergies (e.g. lactose and\u002For gluten intolerance)\n* Suffering from a chronic health condition (could be neurological, cardiovascular, internal and musculoskeletal)\n* Participating in any concomitant care or research trials\n* History of suffering from any mental\u002Fpsychiatric disorders:\n\nSuffering from a higher risk of burn out, indicated by a total score of more than 2.59 on the Burn out assessment tool (BAT) Suffering from high general fatigue, indicated by a score of more than 57 on the Multidimensional fatigue inventory (MFI) Suffering from depression, indicated by a score of more than16 on the Beck depression inventory-II (BDI-II)\n\n* Use of medication Chronic use with an exception for contraceptives Prescribed medication in between or before trials Use of non-prescribed occasional medication 24 hours prior each trial\n* Use of caffeine and heavy efforts 24 hours prior each trial\n* Suffering from colour vision deficiencies\n* Not eating a standardized meal, the morning of each trial",{"count":574,"type":23},62,[576],"PHASE3","The goal of this clinical trial is to determine the role of brain neurotransmission in the onset of fatigue, identify the brain areas involved, and determine how brain activity and neuromuscular efficiency changes during onset of fatigue. Three different experimental studies (physical fatigue, mental fatigue and combined) will be performed with a randomized, single-blinded, placebo controlled, counter-balanced, cross-over design.\n\nThe objectives of the projects are as follows:\n\n* To experimentally assess the role of a dopamine, and a noradrenalin reuptake inhibitor in the onset of exercise-induced fatigue\n* To identify changes in brain activation associated with altered PF and fatigue perception\n* To experimentally assess the effect of a NA or DA reuptake inhibitor on MF, brain activation and the sources of changes in brain activation\n* To experimentally assess the role of brain neurotransmitters (DA, NA) in the interaction between mental and PF from a neurophysiological perspective.\n\nParticipants will be healthy young adults. In each study, they will start with a familiarization trial followed by two experimental trials and one control trial with a randomized treatment order. At each visit, different drugs will be administered to elicit different neurotransmitter response. The trials will be performed at the MFYS exercise lab (BLITS, VUB campus Etterbeek, Boulevard General Jaques 271, 1050 Elsene (Brussels)).\n\nDepending on the type of study they are participating in, participants will perform three distinct tasks:\n\n* In the first experimental study participants will perform a 60-min Stroop Task to elicit mental fatigue.\n* In the second experimental study participants will perform a knee-extension exercise until exhaustion to elicit physical fatigue.\n* In third experimental study participants will first preform a mental fatiguing task (Stroop taks) followed by physical fatigue task (knee extension).\n\nWhile participants will perform above mentioned task their EEG signal and heart rate will be measured. At the same time, participants will report on their subjective feeling of fatigue during these tasks. In addition, all participants will be administered cognitive tasks before and after the study, along with questionnaires. In the second and third experiments, tensiomyography and electromyography will also be recorded from the quadriceps muscle of the leg used for knee extension.\n\nResearchers will compare physiological and behavioural changes in response to specific neurotransmitter drug to answer the main question: what the role of a DA and a NA reuptake inhibitor on the onset of mental and physical fatigue is.",[393],"2025-06-15",{"date":581,"type":59},"2025-06-18",{"date":583,"type":59},"2023-05-03",{"date":585,"type":23},"2025-12-31",{"name":65,"class":66},{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":593,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":19,"minAge":76,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":24,"phases":597,"briefSummary":598,"conditions":599,"keywords":601,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":236},"100593452","combi-smi-multicenter-study-a-person-centered-cognitive-behavioral-intervention-for-severe-mental-illness-100593452","NCT07006623","\"CoMBI-SMI Multicenter Study: A Person-Centered Cognitive-Behavioral Intervention for Severe Mental Illness\"","A Multicenter Study of the Cognitive Model for Behavioral Interventions (CoMBI) as a Personalized Cognitive Behavioral Intervention for Patients With Severe Mental Illness","CoMBI-SMI","Inclusion Criteria:\n\n* Psychogeriatric inpatients aged 18 years and older\n* Clinical diagnosis of a severe mental illness (SMI)\n* Presence of behavioral problems not understood by caregivers\n* Willingness and ability to participate in the study\n\nExclusion Criteria:\n\n\\- Diagnosis of dementia",{"count":596,"type":23},99,[81],"This observational multicenter study aims to evaluate whether the Cognitive Model for Behavioral Interventions - Severe Mental Illness (CoMBI-SMI) can reduce challenging behaviors and psychological symptoms in adults (aged 18 and older) with severe mental illness (SMI). The study is conducted across multiple sites in the Netherlands, Belgium, and the Caribbean, using a stepped-wedge design. All participating departments initially continue their usual care. At different time points, each team receives training in the CoMBI-SMI approach and begins implementing the intervention. This design allows for a comparison between standard care and CoMBI-SMI-based care.\n\nParticipants first receive their usual treatment, during which baseline data are collected on their behavior and psychological symptoms. After the care team is trained in CoMBI-SMI, participants receive CoMBI-SMI-based care for four weeks. They complete questionnaires on behavior, psychological symptoms, and quality of life before and after the intervention. The study aims to assess whether CoMBI-SMI helps reduce challenging behaviors such as aggression or repetitive actions, improve quality of life, and reduce stress for both caregivers and treatment teams. Findings from this study may help improve care for individuals with severe mental illness and provide better support for mental health professionals managing complex behaviors.",[600],"Mental Illness Persistent",[602,41,603,604,605,606],"Severe mental illness","adults","mediationtherapie","Cognitive behavioral therapie","Nursing interventions","2025-06-11",{"date":579,"type":59},{"date":610,"type":23},"2025-09-01",{"date":612,"type":23},"2029-09",{"name":65,"class":66},{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":4,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":19,"minAge":76,"maxAge":20,"enrollmentInfo":621,"targetDuration":4,"studyType":24,"phases":623,"briefSummary":624,"conditions":625,"keywords":626,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":105},"100425766","weight-reduction-in-clbp-100425766","NCT04824248","Weight Reduction in CLBP","The Added Value of a Behavioral Weight Reduction Program to Blended Rehabilitation in Patients With Chronic Low Back Pain: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Overweight (BMI ≥ 25 kg\u002Fm2) or obese (BMI ≥ 30 kg\u002Fm2) with chronic low back pain\n* Non-specific low back pain for at least 3 months' duration\n* Currently seeking care for low back pain\n* Native Dutch speaker\n* Access to internet and computer\u002Ftablet\u002Fsmartphone\n\nExclusion Criteria:\n\n* Leg pain of 7 or higher (on a maximum of 10) on a numeric rating scale\n* Evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy)\n* Evidence of a severe underlying comorbidity (e.g. diabetes, cardiovascular problems, metabolic diseases)\n* BMI ≥ 40 kg\u002Fm2\n* Being pregnant or given birth in the preceding year\n* Currently receiving dietary or exercise interventions",{"count":622,"type":23},84,[81],"We will recruit overweight\u002F obese participants between the age of 18 and 65 with chronic nonspecific low back pain . The participants will be randomly assigned to one of two interventions (each lasting 10 weeks). All interventions will be delivered in a blended format and will be a combination of online education material and face-to-face sessions with a physical therapist. The first group (experimental intervention) will receive a behavioral weight reduction program combined with pain neuroscience education plus cognition-targeted exercise therapy. Participants in the second group (control intervention) will receive pain neuroscience education and cognition-targeted exercise therapy alone. Allocation to the groups will be at random. Participants and assessors will be blinded for group allocation. The primary outcomes is pain intensity. Secondary outcomes include other pain related outcomes, body composition, physical activity, sedentary behavior, dietary intake and function.",[535,534],[627,628,629,630,631,632],"chronic low back pain","chronic pain","physiotherapy","physical therapy","weight reduction","pain management","2025-05-20",{"date":635,"type":59},"2025-05-25",{"date":637,"type":59},"2025-05-01",{"date":639,"type":23},"2026-12-01",{"name":65,"class":66},{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":647,"eligibilityCriteria":648,"healthyVolunteers":18,"sex":19,"minAge":76,"maxAge":649,"enrollmentInfo":650,"targetDuration":4,"studyType":24,"phases":652,"briefSummary":653,"conditions":654,"keywords":657,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":664,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":669,"locationsCount":670},"100583434","implementation-and-evaluation-of-nutrition-interventions-100583434","NCT06876272","Implementation and Evaluation of Nutrition Interventions","Implementation and Evaluation of Two Multicomponent Nutrition Interventions in Higher Education Students","EATFITS","Inclusion Criteria:\n\n* Higher education students:\n\n  * Participant is willing and able to give informed consent for par-ticipation in the study;\n  * Male, female or X, aged 18-24 years;\n  * Healthy higher education students from institution X or campus Y.\n* Adopters and implementers:\n\n  * Persons who are involved in the design, implementation, daily operations or management of the nutrition intervention.\n  * Persons who have knowledge of the specific goals of the nutrition intervention.\n\nExclusion Criteria:\n\n* Higher education students:\n\n  * Students who speak insufficient Dutch;\n  * Students who are less than 18 years old.\n* Adopters and implementers:\n\n  * Persons who speak insufficient Dutch.","24 Years",{"count":651,"type":23},653,[81],"This project aims to implement and evaluate two multi-component dietary interventions focused on promoting healthy and sustainable eating behaviors and preventing weight gain among Flemish higher education students. These interventions will take place over a period of eight weeks and are specifically designed to support healthy lifestyle choices during the transition from secondary school to higher education, a critical period where unhealthy eating behaviors and weight gain are common.\n\nThe interventions will be conducted at a university and a college, utilizing nudges in student restaurants, social media campaigns via Instagram, and workshops to encourage healthy and sustainable eating habits. Effectiveness will be measured using questionnaires administered at three points in time: before the intervention (baseline), immediately after the intervention (post-intervention), and five months later (follow-up). Two other campuses will serve as a control group to compare results.\n\nIn addition to assessing effectiveness, a process evaluation will also be conducted. This will involve focus groups with students and stakeholders, as well as a process questionnaire, to gain insights into the implementation of the interventions and the experiences of those involved. If the interventions prove successful, they may be scaled up to other Flemish institutions as part of a broader strategy for cancer prevention.",[192,655,656],"Nutrition Intervention","Higher Education Students",[658,659,660,661,662],"Nutrition interventions","Healthy eating","Higher education students","Process evaluation","Effect evaluation","2025-03-26",{"date":665,"type":59},"2025-04-01",{"date":667,"type":59},"2025-02-17",{"date":585,"type":23},{"name":65,"class":66},4,{"id":672,"slug":673,"hasResults":12,"nctId":674,"briefTitle":675,"officialTitle":675,"acronym":676,"eligibilityCriteria":677,"healthyVolunteers":12,"sex":19,"minAge":678,"maxAge":77,"enrollmentInfo":679,"targetDuration":165,"studyType":166,"phases":4,"briefSummary":680,"conditions":681,"keywords":683,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":685,"lastUpdatePostDateStruct":686,"startDateStruct":687,"completionDateStruct":688,"leadSponsor":690,"locationsCount":4},"100585591","reliability-and-validity-of-physical-tests-and-musculoskeletal-ultrasound-as-an-add-on-in-classifying-anterior-knee-pain-100585591","NCT06904352","Reliability and Validity of Physical Tests and Musculoskeletal Ultrasound As an Add-on in Classifying Anterior Knee Pain","AKP","Eligibility criteria are subjects, aged 7 to 50 years, with clinically confirmed non-traumatic anterior knee pain (AKP). Subjects must be able to read, understand, and speak Dutch. Before participation, the study protocol was expressed verbally and in writing, and subsequently informed consent was obtained. In addition, we assessed whether participants did understand it.\n\nInclusion Criteria:\n\n* All consecutive patients presenting clinical symptoms of AKP were screened for eligibility.\n\nExclusion Criteria:\n\n* patients with knee effusion, patients having patella instability, surgeries or previous fractured knee joint in the past, systemic pathology including inflammatory joint disease, and patients with interventions in the last three months including corticosteroid injection or physiotherapy.","7 Years",{"count":79,"type":23},"Musculoskeletal ultrasound (MSU) or sonography is a non-invasive diagnostic technique and can extend the clinical examination of Anterior Knee Pain by visualizing musculoskeletal pathology to detect invisible flaws, it is safe, cheap and easy to use in primary care and therefore ensuring substitution of care. The European Society of Musculoskeletal Radiology (ESSR) has concluded that MSU can accurately classify APK pathologies. Protocol-based MSU can detect pathologic changes including cartilage swelling, fragmentation of the tibial tubercle ossification center, patellar tendon lesions, and reactive bursitis of the deep or superficial tibial patellar bursae and is increasingly used by physical therapists in the diagnostic process.\n\nIt is hypothesized that the validity of the physical examination is insufficient to accurately classify different conditions in AKP in patients aged 7-50 years. Therefore the use of MSU as an add-on is essential.\n\nThe purpose of this study is at first to assess the validity of the physical examination and second to evaluate the inter-rater reliability of protocol-based MSU and physical examination, in patients with AKP, in primary care physiotherapy.\n\nThe study is a cross-sectional observational study with four measurements within 60 minutes, without any intervention, performed with a single-gate diagnostic design with the same eligibility criteria for all participants including one group for comparison and measurement. The Strengthening the Reporting of Observational Studies in Epidemiology Statement was used as a guideline.",[682],"Anterior Knee Pain Syndrome",[684],"musculoskeletal ultrasound-physical tests-anterior knee pain-reliability","2025-03-24",{"date":665,"type":59},{"date":665,"type":23},{"date":689,"type":23},"2025-10-01",{"name":65,"class":66},""]