[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intensive-care-unit-icu-acquired-weakness-icu---aw\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intensive-care-unit-icu-acquired-weakness-icu---aw":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,80],{"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":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100603008","functional-electrical-stimulation-to-treat-critical-neuromyopathy-after-severe-stroke-a-pilot-study-100603008",false,"NCT07130929","Functional Electrical Stimulation to Treat Critical Neuromyopathy After Severe Stroke: a Pilot Study.","Intensive Rehabilitation by Functional Electrical Stimulation for the Treatment of Critical Neuromyopathy in Patients With Severe Stroke Admitted to the Highly Specialized Intensive Rehabilitation Unit: a Pilot Study","RISE","Inclusion Criteria:\n\n* Diagnosis of ischemic or hemorrhagic vascular GCA involving unilateral motor deficit \\\u003C 3 months;\n* Premorbid Modified Rankin Scale \\\u003C2;\n* Age \\>18 years and \\\u003C80 years;\n* Level of Cognitive Functioning \\> 4 for active participation in treatment.\n* MRC total sum score \\\u003C= 48 (range 0 -60) for clinical suspicion of ICU-AW\n* Clinical diagnosis of tetra\u002Fparaparesis of peripheral origin confirmed by neurophysiological examination;\n* Signature of informed consent by the patient or, if incapacitated, by their legal representative.\n\nExclusion Criteria:\n\n* Clinical cardio-respiratory or internal instability such as to prevent treatment;\n* History of previous comorbidity for ICU-AW;\n* Previous known chronic neuropathy;\n* Severe coagulopathy;\n* Skin integrity problems at the interface surfaces with the electrostimulator;\n* Epilepsy not controlled by medication;\n* Presence of implanted electronic devices;\n* Pregnancy or breastfeeding;\n* Severe spasticity with a score of \\>3 on the modified Ashworth scale;\n* Treatment with botulinum toxin;\n* Recent malignant neoplasm;\n* Conditions that put you at risk for neuropathies, e.g., history of diabetes mellitus, renal failure, hepatic failure, vitamin deficiencies, chronic alcoholism, vasculitis, previous use of neurotoxic drugs.","ALL","18 Years","80 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study aims to evaluate the effectiveness of physiotherapy treatment combined with functional electrical stimulation (FES) in a small group of patients with severe acquired brain injury (SABI) of vascular origin and with a clinical and instrumental diagnosis of \"Intensive Care Unit-Acquired Weakness\" (ICU-AW). Functional electrical stimulation is a technology that uses electrical impulses, generated by an external device, to reactivate the neuromuscular system through electrodes applied to the skin. In functional electrical stimulation, this process is integrated into physiotherapy sessions, with the active involvement of the patient, through the performance of exercises with the assistance and supervision of the physiotherapist. The rationale behind this is to stimulate neuroplasticity processes by facilitating movement through the application of electrical stimuli and the active participation of the patient in performing a motor task, in an attempt to promote improvement in an impaired function.\n\nIn particular, the objectives that will be pursued are: improvement of lower limb neuromyopathy assessed clinically using the Medical Research Council (MRC) scale, the Fugl-Meyer scale for lower limbs, the Short Physical Performance Battery (SPPB) scale, the assessment of active and passive Range Of Motion (ROM) of the main joints of the lower limb (hip, knee, ankle) and measured instrumentally by neurophysiological examination and ultrasound examination.\n\nAfter randomization, patients in the control arm will be treated with physiotherapy and speech therapy sessions as per the conventional protocol, and an additional 15 physiotherapy sessions lasting 60 minutes over a period of 5 weeks. Alternatively, patients in the experimental group will receive, in addition to conventional rehabilitation treatment, a treatment consisting of 15 physiotherapy sessions combined with FES lasting 60 minutes over a period of 5 weeks.\n\nAt the end of the treatment period, baseline characteristics and clinical and instrumental outcome variables will be compared between the two groups using the chi-square test for dichotomous and categorical variables and the t-test for independent samples or the Mann-Whitney U test for continuous variables, depending on whether or not they are normally distributed. In all analyses, a p-value \\\u003C0.05 will be considered significant.",[28,29],"Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)","Acquired Brain Injury (Including Stroke)",[31,32,33,34,35],"stroke","Intensive Care Unit (ICU) acquired weakness (ICU - AW)","Functional Electrical Stimulation","FES","Rehabilitation","RECRUITING","2025-12-04",{"date":39,"type":40},"2025-12-11","ACTUAL",{"date":42,"type":40},"2025-09-23",{"date":44,"type":22},"2027-03-23",{"name":46,"class":47},"Fondazione Don Carlo Gnocchi Onlus","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":48},"100607683","functional-assessment-in-critically-ill-patients-100607683","NCT07191743","Functional Assessment in Critically Ill Patients","Assessment of Physical Function in Critically Ill Patients With the Chelsea Critical Care Assessment Tool (CPAX)","Inclusion Criteria: All adult patients admitted to the Pedro Ernesto University Hospital (HUPE) General ICU over 18 years of age and with an ICU stay greater than or equal to 48 hours will be included.\n\nExclusion Criteria:\n\n* Pregnancy\n* Inability to record the CPAx score within the first 48 hours of ICU admission or on the day of ICU discharge\n* ICU readmission\n* Known comorbidities causing generalized weakness, such as neuromuscular or neurological diseases",{"count":57,"type":22},186,"10 Days","OBSERVATIONAL","This longitudinal, prospective observational study aims to evaluate functional status in critically ill adult patients in the Intensive Care Unit using the Chelsea Critical Care Physical Assessment Tool (CPAx). The primary objective is to analyze CPAx score variation as a potential predictor of clinical outcomes, including mortality and duration of mechanical ventilation. Functional assessments will be performed at intensive care unit (ICU) admission and discharge to monitor changes in physical function and to predict adverse clinical outcomes.",[62,28],"Intensive Care Unit Acquired Weakness",[64,65,66,67,68,69,70,35],"Critical Care","Intensive Care Units","Physical Therapy Department, Hospital","Muscle Weakness","Functional Status","Physical Functional Performance","Outcome Assessment, Health Care","2025-09-21",{"date":73,"type":40},"2025-09-25",{"date":75,"type":40},"2025-01-01",{"date":77,"type":22},"2027-12-01",{"name":79,"class":47},"Universidade Federal do Rio de Janeiro",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":88,"targetDuration":90,"studyType":59,"phases":4,"briefSummary":91,"conditions":92,"keywords":101,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":4},"100571890","the-nrc-dataset-developing-a-minimum-dataset-for-multidisciplinary-rehabilitation-a-modified-e-delphi-study-100571890","NCT06726135","The NRC Dataset. Developing a Minimum Dataset for Multidisciplinary Rehabilitation: a Modified E-Delphi Study","The National Rehabilitation Centre Dataset. Development of a Minimum Dataset for Multidisciplinary Rehabilitation: a Modified E-Delphi Study","Inclusion Criteria:\n\nThe panel will aim to include clinicians with a minimum of 5 years' experience from a variety of professional backgrounds within the following specialist areas:\n\n* Neuro Rehab\n* Trauma Rehab\n* Community Rehab\n* Outpatient Rehabilitation services\n* Defence medical services\n* Psychology services\n* Amputee Rehab\n* Speech and Language therapy\n* Emergency department\n* Critical Care\n* Trauma and Orthopaedics\n* Rehabilitation Medicine\n\nIt is expected that the expert panel will include:\n\n* Medical Doctors\n* Dietitians\n* Physiotherapists\n* Psychologists\n* Prosthetists\n* Occupational therapists\n* Speech and Language therapists\n* Data-base managers\n* Researchers\u002FAcademics\n* Commissioners\n* Local service managers\n* A department of work and pensions representative\n* An epidemiologist\u002Fdata-scientist with healthcare financial modelling experience\n\nExclusion Criteria:\n\nIndividuals will be excluded from the expert panel for any of the following reasons:\n\n1. They do not have 5 years' experience in their specialist field\n2. They do not have an understanding of various health indicators and the appropriate outcome measure instruments required to evaluate these health indicators.\n3. They have no understanding of how demographic and socio-economic variables impact health outcomes\n4. They have no understanding of how to evaluate clinical effectiveness and cost efficiency of inpatient rehabilitation services.\n5. Their professional background is not represented in the above noted specialist areas",true,{"count":89,"type":22},50,"6 Months","Several rehabilitation datasets are presently in use for specific patient groups in England. The 'National Clinical Audit of Specialist Rehabilitation for patients with complex needs following major injury' (NCASRI) evaluated outcomes within a cohort of Major Trauma patients between 2015 and 2018 using data from two of these datasets. The NCASRI project outlined some of the shortcomings of the pre-existing datasets and highlighted the need for a single National Rehabilitation Dataset to provide long term evaluation of a variety of patient presentations.\n\nThe proposed study will seek to develop such a dataset by means of an E-delphi study. This study will seek consensus from a panel of experts on the data items required to measure the effectiveness and socio-economic impact of multidisciplinary inpatient rehabilitation. Providing commissioners, researchers and clinicians with the data required to improve patient care, conduct research and develop rehabilitation services.\n\nThere are three potential phases to this study:\n\n* Phase one involves the establishment of a core domain set, outlining what information (data) should be included in the NRC core dataset.\n* Phase one will consist of at least 2 rounds of voting, with successive rounds of voting undertaken until an a-priori consensus of 70% is reached for all core data items marked as mandatory\u002Fcritical data in fitting OMERACT guidelines.\n* After 2 rounds, any data item that have reached consensus will be included in the final dataset. These core domain (data items) will then be excluded from subsequent rounds of voting.\n* A maximum of 4 rounds will be allowed in Phase 1. At which point the highest-ranking data items remaining with a consensus above 60% from each of the pre-identified categories will be included in the final dataset.\n* Phase two will explore what tools should be used to collect the core domains (outcome measure instruments) for each category outlined in phase 1.\n* Phase 2 will follow the same protocol for including outcome measure instruments into the core outcome set as were required to include core data items from phase 1.\n* If a consensus of equal or greater than 60% cannot be reached using an E-Delphi method in either phase 1 or phase 2 then a virtual meeting will be held amongst all expert panel members to reach consensus using a nominal group technique (phase 3).",[93,94,95,96,97,98,99,28,100],"Pain","Traumatic Brain Injury","Major Trauma","Multiple Sclerosis","Amputees \u002F Rehabilitation","Spinal Cord Injuries (SCI)","Functional Neurological Disorder","Trauma Related Injuries",[102,103,104,35,105,106,107,108,109],"E-delphi","Delphi","Multidisciplinary","Core outcome set","Dataset","national rehabilitation centre","outcome measure instruments","inpatient","NOT_YET_RECRUITING","2024-12-15",{"date":113,"type":40},"2024-12-19",{"date":115,"type":22},"2025-01",{"date":117,"type":22},"2025-06",{"name":119,"class":47},"ThomasCorbett"]