[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Vic - Central University of Catalonia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":241},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,50,83,110,144,180,208],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100631613","effectiveness-of-a-multimodal-outpatient-supervised-physical-activity-program-to-improve-tolerance-and-efficacy-of-chemotherapy-in-adults-with-breast-lung-and-colon-cancer-100631613",false,"NCT07502963","Effectiveness of a Multimodal Outpatient Supervised Physical Activity Program to Improve Tolerance and Efficacy of Chemotherapy in Adults With Breast, Lung and Colon Cancer","Effectiveness of a Multimodal Outpatient Supervised Physical Activity Program to Improve Tolerance and Efficacy of Chemotherapy in Adults With Breast, Lung and Colon Cancer: Randomized Clinical Trial.","PREDU","Inclusion Criteria:\n\n* Women and men aged 35 to 65 years\n* Diagnosed with stage II, III, or IV breast, lung, or colon cancer\n* Scheduled to start neoadjuvant chemotherapy\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Musculoskeletal or neurological disorders that prevent proper execution of the exercises\n* Uncontrolled infections or symptoms\n* Comorbidities such as chronic obstructive pulmonary disease (COPD), respiratory failure, or recent cardiovascular events within the past 6 months\n* Body mass index (BMI) over 35\n* Pregnant women\n* Difficulty understanding the purpose and procedures of the study","ALL","35 Years","65 Years",{"count":21,"type":22},70,"ESTIMATED","INTERVENTIONAL",[25],"NA","This clinical study evaluates whether a supervised, multimodal therapeutic exercise program started before chemotherapy and continued during treatment can improve treatment outcomes in patients aged 35 to 65 years with breast, lung, or colon cancer.\n\nThe study hypothesis is that participation in this exercise program improves tolerance to chemotherapy, allowing patients to receive more than 85% of the planned relative dose intensity. In addition, the program is expected to enhance treatment effectiveness by increasing the rate of complete radiological response.\n\nThe main objective of the study is to assess the effectiveness of a supervised, multimodal therapeutic exercise program performed before and during chemotherapy in improving both treatment tolerance and treatment efficacy in patients with breast, lung, and colon cancer.",[28,29,30,31,32,33],"Breast Cancer","Lung Cancer (Non-Small Cell)","Colorectal Cancer","Physical Activity","Neoadjuvant Chemotherapy Tolerance","Strength and Endurance",[28,29,35,31,36,32],"Colorectal cancer","Strength and endurance","NOT_YET_RECRUITING","2026-03-24",{"date":40,"type":41},"2026-03-31","ACTUAL",{"date":43,"type":22},"2026-04",{"date":45,"type":22},"2027-10",{"name":47,"class":48},"University of Vic - Central University of Catalonia","OTHER",3,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100631021","effectiveness-of-combined-super-inductive-system-sis-therapy-with-therapeutic-exercise-and-health-education-in-lateral-elbow-tendinopathy-100631021","NCT07495254","Effectiveness of Combined Super Inductive System (SIS) Therapy With Therapeutic Exercise and Health Education in Lateral Elbow Tendinopathy","Effectiveness of Combined Super Inductive System (SIS) Therapy With Therapeutic Physical Therapy Exercise and Health Education in Lateral Elbow Tendinopathy","SIS","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Clinical diagnosis of lateral elbow tendinopathy confirmed by a Family Care Physician, Rehabilitation Physiatrist, Orthopedic Surgeon, or Rheumatologist.\n* Referral to one of the three participating Rehabilitation and Physical Therapy Services (Mataró, Sant Andreu, or Drassanes).\n* Presence of at least one positive provocative test (Cozen's test or Mill's test).\n* Ability and willingness to participate in the study after reading the patient information sheet and signing the informed consent, including consent for image use.\n\nExclusion Criteria:\n\n* Medial elbow tendinopathy.\n* Recent traumatic injury to the affected upper limb within the past 6 months.\n* Passive elbow joint range of motion limited by more than 20°.\n* Injection in the affected elbow within 6 weeks prior to baseline assessment.\n* Systemic inflammatory, autoimmune, infectious, or neoplastic disease.\n* Pregnancy.\n* Metal implants in the affected elbow region.\n* Pacemaker or implantable defibrillator.\n* Radial tunnel syndrome \u002F Frohse arcade syndrome.\n* Coagulation disorders.\n* Cognitive or sensory impairment that precludes participation in the study procedures.\n* Central sensitization syndromes (e.g., fibromyalgia, chronic fatigue syndrome).","18 Years",{"count":60,"type":22},224,[25],"Background Lateral epicondylalgia is the most common cause of lateral elbow pain and affects approximately 1% to 3% of the population. It reduces strength, functionality, and quality of life, leading to limitations in work and daily activities and representing a relevant public health concern.\n\nCurrent scientific evidence suggests conservative physical therapy as the first-line treatment; however, heterogeneity exists among approaches, and clinical guidelines remain unclear. Rest and pharmacological treatment may provide short-term relief but do not resolve the underlying condition and may lead to recurrences.\n\nTherapeutic exercise has been shown to improve pain, strength, and function and is recommended as a first-line conservative intervention due to its favorable cost-benefit ratio. Thermotherapy and electrotherapy may also reduce pain and improve function compared with placebo.\n\nThis study aims to evaluate the efficacy of the Super Inductive System (SIS) combined with a conventional physical therapy program.\n\nHypothesis SIS therapy, combined with an upper extremity therapeutic exercise program and health education, will reduce pain, improve mobility and limb function, increase grip strength, facilitate return to activities of daily living (ADLs), and enhance perceived quality of life in individuals with lateral elbow tendinopathy.\n\nObjective To assess the effectiveness of SIS combined with therapeutic exercise and health education in adults aged 18 years and older with lateral elbow tendinopathy, compared with the application of SIS at a non therapeutic dose combined with conventional therapeutic exercise and health education.\n\nMethodology A prospective, experimental, randomized clinical trial will be conducted using a triple blind design (principal investigator, assessor, and participant). The study will include an intervention group (IG) (SIS at a therapeutic dose plus therapeutic exercise and health education) and a control group (CG) (SIS at a non therapeutic dose plus therapeutic exercise and health education).\n\nThis multicenter study will take place at three Rehabilitation and Physical Therapy Services (Mataró, Sant Andreu-Barcelona, and Drassanes-Barcelona), all part of the Primary Care network of the Catalan Health Institute (ICS).\n\nData collection will occur at baseline, post treatment, and at 3 and 6 month follow ups.\n\nOutcome measures will assess pain using the Visual Analog Scale (VAS) and algometry, mobility through goniometric evaluation, upper limb function using the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH), grip strength with dynamometry, health related quality of life with the EQ 5D 5L, and elbow specific pain and functional status using the Patient-Rated Tennis Elbow Evaluation (PRTEE).\n\nInferential analyses will be performed for within group and between group comparisons. Data will be processed in accordance with current legislation.\n\nData management will be performed using REDCap (Research Electronic Data Capture).\n\nExpected Outcomes A statistically significant improvement is expected in the intervention group compared with the control group. The use of SIS may contribute to reduced recovery time, fewer and shorter temporary work disabilities, and lower pharmaceutical costs among individuals with lateral epicondylalgia.\n\nApplicability and Relevance SIS is an innovative non invasive therapeutic technology that reduces acute and chronic pain, improves joint mobility, and promotes muscle strengthening in tendinopathies. Demonstrating its effectiveness and cost efficiency may support its incorporation into routine clinical practice, potentially reducing treatment duration, recovery time, and reliance on pharmacological therapy.\n\nThis study will provide evidence to inform the implementation of SIS as an additional therapeutic tool in primary care physical therapy and rehabilitation settings.",[64,65,66],"Lateral Epicondylitis (Tennis Elbow)","Lateral Epicondylalgia","Lateral Elbow Tendinopathy",[68,69,70,71,72,73],"Lateral Epicondylitis","Super Inductive System","high-intensity electromagnetic stimulation","exercises","pain","functionality","2026-03-22",{"date":76,"type":41},"2026-03-27",{"date":78,"type":22},"2026-03-30",{"date":80,"type":22},"2028-09-01",{"name":47,"class":48},1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":82},"100595867","nutrition-in-action-service-learning-project-100595867","NCT07038031","Nutrition in Action: Service-Learning Project","NA_SL","Inclusion Criteria:\n\n* University students enrolled in the Food Education Strategies subject of the Nutrition and Dietetics Degree at the UVic-UCC.\n\nExclusion Criteria:\n\n* Online students.\n* Students who do not voluntarily agree to participate in the study",{"count":91,"type":22},65,"OBSERVATIONAL","Service-learning methodology (SL) combines training and community processes in a single project where participants are trained while working on real needs of the environment with the aim of improving it. This methodology enhances the professional skills of the students, their personal and competence development, and develops a deeper sense of civic responsibility.\n\nThe Human Nutrition and Dietetics Degree (ND) of the Faculty of Health and Welfare Sciences (FCSB) of the University of Vic-Central University of Catalonia decided to incorporate this methodology, according to University's training model, with the aim of generating learning situations that allow them to act, reflect and solve problems based on significant learning. We applied SL in the subject of Food Education Strategies designing and implementing a small food education program with 1 contact to detect the needs of the users, and 3 educational sessions. The implementation of the SL is based on the SL guide proposed by the Service Learning Network of Catalan Universities and we make it with 4 local social entities.\n\nThe teacher responsible for the SL is coordinated with responsibles from entities who act as facilitators, authorizing the collection of data from the people of the entities, recruiting, informing and collecting the willingness to participate from the users.\n\nWe plan to study the experience of participating in the SL activity in terms of student acquisition of skills and satisfaction of all the parties involved, based on an observational study carried out during 4 academic years (2025-2029).\n\nThrough convenience sampling, a participation of 65 people is expected (20 students, 40 users, 5 responsible from entities).\n\nData collection plans to compile information on: a.Experience of the SL of the university student body. b. Assessments of the users and responsibles from entities on the impact, quality and satisfaction with the SL activity. c. Proposal for improving the SL activity with the entities using the rubric for self-assessment and improvement of SL projects.\n\nData collection will take place at the end of the activity using the REDCap platform (Research Electronic Data Capture) and the statistic analysis is planned using the SPSS statistical program.",[95,96],"Skills Acquisition","Satisfaction",[98,99,100,101],"Service-learning","Skills","Food habits","Higher education","2025-06-25",{"date":104,"type":41},"2025-06-26",{"date":106,"type":22},"2026-02-01",{"date":108,"type":22},"2026-06-30",{"name":47,"class":48},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":121,"conditions":122,"keywords":127,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},"100594261","immersive-functional-virtual-reality-in-people-with-acquired-brain-injury-and-unilateral-spatial-neglect-100594261","NCT07017140","Immersive Functional Virtual Reality in People With Acquired Brain Injury and Unilateral Spatial Neglect","Immersive Functional Virtual Reality in People With Acquired Brain Injury and Unilateral Spatial Neglect: A Feasibility and Usability Study","REVINE","Inclusion Criteria:\n\n* Age 18 years or older.\n* Diagnosis of acquired brain injury (stroke or traumatic brain injury) in the subacute phase (\\>7 days to 6 months) or chronic phase (\\>6 months).\n* Presence of unilateral spatial neglect, defined as omission of 6 or more bells on the left hemifield in the Bells Cancellation Test.\n* Currently receiving care at the Outpatient Rehabilitation Service of the Consorci Hospitalari de Vic or at Vall d'Hebron University Hospital, or listed in the historical patient registry of these centers.\n* Presence of mild to moderate upper limb impairment, defined as a score \\>29 on the Fugl-Meyer Upper-Extremity scale.\n* Medically stable and eligible to begin a rehabilitation program.\n* Willing to participate in the study and able to provide signed informed consent.\n\nExclusion Criteria:\n\n* Delirium and\u002For behavioral disturbances that prevent the participant from following simple instructions.\n* Severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score below 18, that interferes with the use of virtual reality.\n* Severe visual and\u002For auditory impairment that prevents the use of immersive VR goggles.\n* Severe language comprehension difficulties that interfere with the instructions during the intervention.\n* Hypersensitivity that prevents the placement of the VR headset.\n* Headache or dizziness induced by the use of VR goggles.\n* History of photosensitive epilepsy.",{"count":119,"type":22},30,[25],"Unilateral spatial neglect (USN) is a common and highly disabling condition following acquired brain injury (ABI), significantly impairing individuals' ability to perform daily activities and reducing their autonomy. It frequently affects patients who have suffered a stroke or traumatic brain injury, and it is often associated with worse functional outcomes and increased care needs. Despite advances in neurorehabilitation, conventional assessment and treatment tools for USN have shown limitations in sensitivity and ecological validity.\n\nImmersive Functional Virtual Reality (IFVR) is an emerging and promising technology that creates controlled, interactive environments, facilitating both assessment and rehabilitation in a motivating and safe way. The REVINE study explores the feasibility, usability, and preliminary clinical effects of an immersive VR-based intervention tailored to address motor and spatial deficits in adults with ABI and USN.\n\nThis is a prospective, non-controlled feasibility study using a single-group interrupted time series design. Participants (N=30) will be recruited from two neurorehabilitation services in Catalonia (Spain): the Neurological Rehabilitation and Brain Injury Unit at Vall d'Hebron University Hospital and the Outpatient Rehabilitation Service at Consorci Hospitalari de Vic. Eligible participants will be adults with ABI in the subacute or chronic phase, presenting USN (as measured by the Catherine Bergego Scale and the Bells Cancellation Test) and mild-to-moderate upper limb impairment.\n\nThe intervention consists of 12 supervised individual IFVR sessions (30 minutes\u002Fsession, 3 times\u002Fweek for 4 weeks), using the KINESIX system (NeuroGroup XR Inc., Montreal, Canada). A progressive series of gamified tasks will be delivered through immersive VR, targeting spatial exploration and upper limb function, with adjustable difficulty and real-time feedback.\n\nParticipants will undergo three pre-intervention and three post-intervention evaluations, spaced one month apart. Clinical outcomes include the degree of USN (measured by the Catherine Bergego Scale, the Bells Cancellation Test, and the KINESIX light-reaching test), usability (System Usability Scale), and satisfaction (User Satisfaction Evaluation Questionnaire). Feasibility outcomes include recruitment and retention rates, adherence to treatment, session completion times, adverse events, and therapist assistance level.\n\nWe hypothesize that IFVR will be a viable and well-accepted intervention, with high user satisfaction, minimal adverse effects, and measurable improvements in neglect-related outcomes. This study aims to inform the future design of larger-scale trials and support the integration of IFVR into routine neurorehabilitation settings or home-based telerehabilitation programs.",[123,124,125,126],"Acquired Brain Injury Including Stroke","Unilateral Spatial Neglect (USN)","Stroke","Traumatic Brain Injury",[128,129,130,131,132,133,134],"acquired brain injury","unilateral spatial neglect","stroke","traumatic brain injury","cognitive and motor rehabilitation","virtual reality-based therapy","virtual reality","2025-06-10",{"date":137,"type":41},"2025-06-12",{"date":139,"type":22},"2025-10-01",{"date":141,"type":22},"2029-02-01",{"name":47,"class":48},2,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":152,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},"100560944","keep-on-keep-up-bladder-health-co-creating-and-testing-a-self-management-technological-solution-for-ageing-well-100560944","NCT06583733","Keep On Keep Up Bladder Health: Co-creating and Testing a Self-management Technological Solution for Ageing Well","On Any Page, Select Quit to Stop Entering Data. Data Entered on Previous Pages Will be Retained: To Complete Data Entry Later, Open the Record From the Home Page","KOKU Bladder","Inclusion Criteria:\n\n* Age ≥50 (range used in the literature covering the late-life process, including prostate issues and the perimenopause period)\n* Self-reported UI (at least 1 leakage\u002Fmonth)\n* Ability to read and understand the national languages\n* Have a mobile phone\u002Ftablet\n* Sign informed consent.\n\nExclusion Criteria:\n\n* Red-flag symptoms (e.g., bleeding)\n* Unstable health conditions.","50 Years","100 Years",{"count":155,"type":22},120,[25],"KOKU Bladder aims to develop and test an evidence based digital health program with behavior change techniques to improve bladder health of adults aged 50 and over. A novel module embedded in the approved app \"Keep-on-Keep-up\" (KOKU) will be co-created with end-users, researchers, health professionals, and stakeholders through a participatory and appreciative action and reflection methodology. After a comprehensive literature review and consultation with 4-6 experts, 6 focus groups will be undertaken in Kaunas(Lithuanian), Catalonia (Spain) and Manchester (UK) to co-create the contents of the module. Data will be analyzed using thematic analysis. Gamification and the Honeycomb model for user experience will be followed to achieve an appropriate technological solution that will be tested through a randomized controlled trial with at least 120 individuals. A mixed methods approach (quantitative\u002Fqualitative analysis) will be used to assess the feasibility and acceptability of the program. Open data and science, gender and ethical aspects, as well as a risk management plan are considered. A plan for communication, dissemination, exploitation of results will be considered. KOKU Bladder will be highly scalable and will have wide reach and impact. This proposal is in line with EU policy initiatives on Active and Healthy Ageing (bladder health and continence will be promoted), targeting aspects such as eHealth, Innovation and Digital Care Transformation, by supporting users to demand more responsive and integrated care programs for chronic conditions and enhancing self-management strategies, independence and health intelligence.",[159],"Urinary Incontinence in Old Age",[161,162,163,164,165,166,167,168,169],"pelvic health","urinary incontinence","aged","eHealth","behavior change","physical activity","sedentary behavior","bladder health","technology","RECRUITING","2025-03-27",{"date":173,"type":41},"2025-03-30",{"date":175,"type":41},"2025-03-24",{"date":177,"type":22},"2028-10-01",{"name":47,"class":48},4,{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":187,"sex":17,"minAge":188,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":23,"phases":191,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":82},"100584514","a-service-learning-program-for-comprehensive-geriatric-assessment-and-health-promotion-in-older-adults-100584514","NCT06890325","A Service-Learning Program for Comprehensive Geriatric Assessment and Health Promotion in Older Adults","GEROS","Inclusion Criteria:\n\nA) For users:\n\n* Any person aged 60 or older who can move to the facility (Faculty of Health Sciences and Welfare) independently or accompanied by a caregiver.\n\nB) For students:\n\n* Students from Nursing, Physiotherapy, Nutrition and Dietetics, Occupational Therapy and Psychology degrees of UVic-UCC.\n\nExclusion Criteria:\n\n* For users: Individuals institutionalized in a long-term care institution.",true,"60 Years",{"count":190,"type":22},100,[25],"The GEROS Project aims to develop and implement a Service-Learning (S-L) program that integrates Comprehensive Geriatric Assessment (CGA) and health promotion, for students at the Faculty of Health Sciences and Welfare at the University of Vic - Central University of Catalonia (UVic-UCC). This initiative engages university students, healthcare professionals, and older adults (60+) in a participatory, intergenerational approach that fosters mutual learning and community engagement.\n\nThe study follows a non-experimental mixed-method design, involving students from Nursing, Physiotherapy, Human Nutrition and Dietetics, Occupational Therapy, and Psychology. Participants include older adults (60+) who can independently travel to the university.\n\nThe project is integrated into different subjects, in groups of 4-5 students, participants conduct a Comprehensive Geriatric Assessment (CGA), evaluating frailty using VIG-Frail, intrinsic capacity with ICOPE, quality of life with EUROQOL 5D-5L, and specific health indicators with Nursing Outcomes Classification (NOC).\n\nTo assess the program's effectiveness, several outcome measures will be analyzed including students' perceived knowledge, competencies, and skills, as well as older adults' awareness of their health status, lifestyle, and risk factors. Additionally, the satisfaction levels of both will be evaluated. The items will be evaluated using a 1-5 Likert Scale, and the analysis will be conducted with SPSS. Data recording will be carried out through REDCap.\n\nThe GEROS Project aligns with the United Nations' Sustainable Development Goals (SDGs), specifically SDG 3 (Good Health and Well-being) and SDG 10 (Reduced Inequalities). By offering care to the aging population and providing them with personalized health recommendations, the project promotes preventive strategies, active aging, and intergenerational learning.\n\nFurthermore, GEROS integrates innovative educational methodologies, encouraging experiential learning, collaboration with healthcare professionals, and the development of practical skills in real-world contexts. The program's scalability and adaptability could serve as a model for other universities and healthcare institutions aiming to enhance geriatric care through service-learning initiatives.",[194,195,196,197,198,199,200],"Frailty","Older People","Comprehensive Geriatric Assessment","Health Promotion","SERVICE LEARNING","Students","Student Education","2025-03-19",{"date":175,"type":41},{"date":204,"type":41},"2024-11-11",{"date":206,"type":22},"2025-12-20",{"name":47,"class":48},{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":187,"sex":17,"minAge":216,"maxAge":217,"enrollmentInfo":218,"targetDuration":220,"studyType":92,"phases":4,"briefSummary":221,"conditions":222,"keywords":228,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":82},"100574863","association-between-motor-skills-and-sensory-profiles-in-children-with-typical-and-atypical-development-aged-4-to-11-years-100574863","NCT06764810","Association Between Motor Skills and Sensory Profiles in Children With Typical and Atypical Development Aged 4 to 11 Years","Association Between Motor Skills and Sensory Profiles in Children With Typical and Atypical Development Aged 4 to 11 Years: A Cross-Sectional Observational Case-Control Study","MOTISEN","Inclusion Criteria:\n\n* Children aged 4 to 11 years.\n* Typical or atypical neurodevelopment, defined as follows:\n* ASD: Subclinical symptoms or Level 1 diagnosis.\n* ADHD: Predominantly inattentive, hyperactive\u002Fimpulsive, or combined presentation. For children under 6, typical symptoms of the disorder (e.g., impulsivity, hyperactivity).\n* DCD: Diagnosed or meeting the following criteria:\n\n  * Motor skills below age expectations.\n  * Significant impact on daily activities or school performance.\n  * Difficulties not attributable to another condition.\n* Parental\u002Flegal guardian consent.\n\nExclusion Criteria:\n\n* Moderate to severe intellectual disability (IQ ≤ 51).\n* Neurological disorders (e.g., cerebral palsy) or syndromes.\n* Severe visual and\u002For auditory impairments.\n* Severe behavioral disorders.\n* Severe mental health disorders (e.g., depression, severe anxiety).","4 Years","11 Years",{"count":219,"type":22},40,"1 Month","Background and Justification Childhood developmental disorders, such as Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), and Developmental Coordination Disorder (DCD), pose significant challenges for children and their families. These disorders impact children's growth and learning, leading to difficulties in key areas such as language, communication, behavior, social interaction, and motor skills. Research in this area is limited, particularly regarding fine and gross motor skills in relation to sensory processing in children with these diagnoses.\n\nHypothesis and Objectives There is an association between motor skills and sensory processing in children aged 4 to 11 years, depending on whether they have typical or atypical neurodevelopment, such as ASD, ADHD, and DCD.\n\nMain Objective:\n\nTo evaluate the association between motor skills and sensory processing in children aged 4 to 11 years with either typical or atypical neurodevelopment (e.g., ASD, ADHD, and DCD).\n\nSecondary Objectives:\n\nTo describe and compare motor skills among children aged 4 to 11 years with typical or atypical neurodevelopment, such as ASD, ADHD, and DCD.\n\nTo describe and compare sensory processing among children aged 4 to 11 years with typical or atypical neurodevelopment, such as ASD, ADHD, and DCD.\n\nMethodology The study is a cross-sectional observational case-control study. Participants are users of the Child Development and Early Intervention Center (CDIAP) Tris Tras, Neuro Xics, or Criv in Vic.\n\nThe sample will include 30 children as controls (typical neurodevelopment) and 10 children as cases (atypical neurodevelopment: ASD, ADHD, DCD).\n\nChildren will be assessed using the Infant Motor Profile (IMP) to measure motor development and the Short Sensory Profile-2 (SSP-2) to evaluate sensory processing.\n\nStatistical Analysis Quantitative variables will be described using means and standard deviations, while categorical variables will be presented as frequencies and percentages. Statistical tests such as the Student's t-test will be used to compare means between two groups, ANOVA for comparisons among more than two groups, and the Chi-square test to analyze associations between categorical variables.\n\nExpected Results The study is expected to provide essential insights into the differences in motor development between children with typical and atypical neurodevelopment, as well as the relationship between biological and external factors and these differences. These findings could help improve clinical and educational interventions for these children by tailoring them to their specific needs, thereby enhancing their overall well-being and development.\n\nEthical Considerations The study protocol will be submitted to the Research Ethics Committee (CER) of UVic-UCC, adhering to good clinical practice guidelines in accordance with the Declaration of Helsinki. Participants will be assigned a code to ensure data pseudonymization, with data securely stored on the Microsoft 365 server of UVic-UCC. Participants will have the right to withdraw from the study at any time, and personal data will be deleted once the study is completed.\n\nResearchers will ensure confidentiality as dictated by Organic Law 3\u002F2018 of December 5 on the Protection of Personal Data and Guarantee of Digital Rights, Regulation (EU) 2016\u002F679 of April 27, 2016, on data protection, and complementary regulations, as well as Organic Law 1\u002F1982 of May 5 on the right to honor, personal and family privacy, and self-image.",[223,224,225,226,227],"Developmental Disability","Autism Spectrum Disorder","Development Coordination Disorder","Attention Deficit Disorder With Hyperactivity","Typical Development",[229,230,231,232],"motor skills disorders","physical therapy modalities","pediatrics","child development","2025-01-09",{"date":235,"type":41},"2025-01-13",{"date":237,"type":41},"2024-12-01",{"date":239,"type":22},"2026-12-20",{"name":47,"class":48},""]