[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626040":3},{"organization":4,"outcomesModule":7,"designInfo":66,"detailedDescription":69,"studyPopulation":69,"armGroups":76,"interventions":89,"overallOfficials":69,"centralContacts":69,"locations":99,"responsibleParty":118,"collaborators":69,"id":122,"slug":69,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":69,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":69,"enrollmentInfo":130,"targetDuration":69,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":146,"whyStopped":69,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"European University of Madrid","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Action Research Arm Test (ARAT)","The ARAT assesses upper-limb functionality across four domains: grasp, grip, pinch, and gross movement. Scores range from 0 to 57, with higher scores indicating better upper-limb function and less impairment.","Baseline (V0), Week 8 (V1), Week 16 (V2)",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"EuroQol EQ-5D-5L","The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) is a standardized measure of health-related quality of life. It provides (1) a utility index score, ranging from -0.281 to 1.000, where higher scores indicate better health status, and (2) a Visual Analog Scale (VAS) ranging from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health.","Baseline, Week 8, Week 16",{"measure":19,"description":20,"timeFrame":17},"Wolf Motor Function Test (WMFT)","Assesses upper-limb motor performance through timed tasks and strength measures. Scores range from 0 to 75, with higher scores indicating better motor function.",{"measure":22,"description":23,"timeFrame":17},"Fugl-Meyer Assessment for Upper Extremity (FMA-UE)","Evaluates motor function, sensation, passive joint mobility, and joint pain. Total scores range from 0 to 66, with higher scores indicating better motor recovery.",{"measure":25,"description":26,"timeFrame":17},"ABILHAND Questionnaire","The ABILHAND Questionnaire is a patient-reported measure of perceived manual ability during bimanual activities of daily living. Each item is rated using three response categories: \"impossible,\" \"difficult,\" and \"easy.\" Responses are converted through Rasch analysis into a linear measure of manual ability. The official scoring system provides Rasch-transformed results that can be expressed on a 0-100 scale, where 0 represents the lowest manual ability and 100 represents the highest manual ability.Higher scores indicate better perceived manual ability.",{"measure":28,"description":29,"timeFrame":30},"Postural Compensations","Postural control will be evaluated as the number of compensatory postural movements detected by the digital platform during each training session. Higher values indicate poorer postural control.","During each training session across the 8-week intervention period.",[32,36,40,44,48,52,56,60,63],{"measure":33,"description":34,"timeFrame":35},"Adherence to the Rehabilitation Program","Percentage of completed sessions out of the prescribed 40 sessions. Adherence ≥80% is considered adequate.","Throughout the 8-week intervention",{"measure":37,"description":38,"timeFrame":39},"Effective Practice Dose","Total minutes of active motor or cognitive task execution, recorded by the physiotherapist.","Each session (summed across intervention period, up to 8 weeks)",{"measure":41,"description":42,"timeFrame":43},"Movement Accuracy","Movement accuracy will be quantified as the number of correctly performed task executions recorded by the digital platform during each training session. Higher values indicate better task performance and motor control.","During each training session during the 8week-intervention program",{"measure":45,"description":46,"timeFrame":47},"Perceived Effort (Modified Borg Scale 0-10)","Perceived effort will be assessed using the Modified Borg Scale, a validated measure of perceived exertion that ranges from 0 (\"nothing at all\") to 10 (\"maximal\").Higher scores indicate greater perceived exertion. Participants will report their perceived effort immediately after each training session.","End of each session (up to 40 minutes)",{"measure":49,"description":50,"timeFrame":51},"Professional Workload","Total number of minutes the physiotherapist dedicates to preparing, supervising, and documenting each session.","Each session across the 8 week-intevention program",{"measure":53,"description":54,"timeFrame":55},"Usability (System Usability Scale, SUS)","Assesses usability of the exergame system. Scores range from 0 to 100. Higher scores indicate better usability.","Week 8",{"measure":57,"description":58,"timeFrame":59},"Social Value","Social value will be assessed by estimating the healthcare resource use avoided due to the intervention (e.g., reduced need for follow-up visits, unscheduled care, or additional rehabilitation). Results will be reported as the estimated number of avoided healthcare contacts during the study period. Higher values indicate greater social value generated by the intervention.","Week 8 and Week 16",{"measure":61,"description":62,"timeFrame":55},"Patient Satisfaction (5-point Likert Scale)","Patient satisfaction will be assessed using a 5-point Likert scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction with the intervention. The variable will be analyzed as an ordinal outcome.",{"measure":64,"description":65,"timeFrame":59},"Cost-Effectiveness","Cost-effectiveness will be evaluated by calculating the Incremental Cost-Effectiveness Ratio (ICER), expressed as cost per quality-adjusted life year (€\u002FQALY) gained. The ICER will be derived by comparing the total direct costs of the intervention (including professional time, materials, and technical support) with the health utility outcomes measured through the EQ-5D-5L. Higher ICER values indicate lower cost-effectiveness.",{"allocation":67,"interventionModel":68,"interventionModelDescription":69,"primaryPurpose":70,"observationalModel":69,"timePerspective":69,"maskingInfo":71},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":72,"maskingDescription":73,"whoMasked":74},"SINGLE","Outcome assessors will remain blinded to group allocation throughout the study. Participants and therapists will not be blinded due to the nature of the interventions.",[75],"OUTCOMES_ASSESSOR",[77,83],{"label":78,"type":79,"description":80,"interventionNames":81},"Exergame-Based Semi-Autonomous Program","EXPERIMENTAL","Participants will complete a semi-autonomous home-based exergame rehabilitation program targeting upper-limb motor and sensory function. The program integrates multisensory feedback, motor sequencing, coordination, and dual-task demands. Remote supervision will be provided by a physiotherapist.\n\nDose: 30-40 minutes per session, 5 sessions\u002Fweek for 8 weeks\n\nMode of Delivery: Home-based with remote monitoring",[82],"Behavioral: Exergame-Based Upper Limb Rehabilitation Program",{"label":84,"type":85,"description":86,"interventionNames":87},"Conventional Physiotherapy Program","ACTIVE_COMPARATOR","Participants will complete an individualized home-based physiotherapy program including strengthening exercises and functional upper-limb tasks, matched in duration and frequency to the experimental arm.\n\nDose: 30-40 minutes per session, 5 sessions\u002Fweek for 8 weeks\n\nMode of Delivery: Home exercise program with standard follow-up",[88],"Behavioral: Conventional Home-Based Physiotherapy",[90,95],{"type":91,"name":92,"description":93,"armGroupLabels":94,"otherNames":69},"BEHAVIORAL","Exergame-Based Upper Limb Rehabilitation Program","Participants in the experimental group will complete a semi-autonomous home-based exergame rehabilitation program targeting upper-limb motor, sensory, and perceptual function. The intervention integrates intensive motor practice, multisensory feedback, dual-task demands, visuomotor coordination, and progressive task difficulty. Remote supervision will be provided by a physiotherapist to monitor adherence, adjust progression, and ensure safety.\n\nDose and Schedule:\n\n5 sessions per week 30-40 minutes per session Duration: 8 weeks\n\nMode of Delivery:\n\nHome-based training using therapeutic exergames, with remote monitoring and session review by a physiotherapist.",[78],{"type":91,"name":96,"description":97,"armGroupLabels":98,"otherNames":69},"Conventional Home-Based Physiotherapy","Participants in the control group will follow a conventional individualized physiotherapy program focused on upper-limb motor rehabilitation. The program includes strengthening exercises, functional upper-limb tasks, and repetitive practice designed to match the dose and duration of the experimental group.\n\nDose and Schedule:\n\n5 sessions per week 30-40 minutes per session Duration: 8 weeks\n\nMode of Delivery:\n\nHome-based exercises with standard clinical follow-up and therapist support as needed.",[84],[100],{"facility":101,"status":69,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":113},"Universidad Europea de Madrid","Villaviciosa de Odón","Madrid","28670","Spain","ES",{"type":108,"coordinates":109},"Point",[110,111],-3.9043,40.3581,{"lat":111,"lon":110},[114],{"name":115,"role":116,"phone":69,"phoneExt":69,"email":117},"Marina Castel-Sánchez, PhD","CONTACT","marina.castel@universidadeuropea.es",{"type":119,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":69,"oldOrganization":69},"SPONSOR_INVESTIGATOR","Marina Castel Sánchez","Associate Professor","100626040",false,"NCT07430462","Home-Based Exergame Rehabilitation for Upper Limb Function in People With Multiple Sclerosis","Effectiveness and Feasibility of a Home-Based Exergame Rehabilitation Protocol for Upper Limb Function in Individuals With Multiple Sclerosis: A Randomized Controlled Pilot Trial","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Clinical diagnosis of Multiple Sclerosis with EDSS score between 2.0 and 6.5, with upper-limb involvement.\n* Ability to maintain independent sitting and to stand with or without assistive devices.\n* Upper-limb functional capacity between 11 and 54 points on the ARAT, indicating limited to substantial impairment.\n* Cognitive ability to understand and follow simple instructions, demonstrated by a Mini-Mental State Examination score ≥ 23.\n* Provision of written informed consent by the participant or legally authorized representative.\n\nExclusion Criteria:\n\n* Acute illness, musculoskeletal injury, or pain interfering with the ability to perform the intervention exercises.\n* Uncompensated visual or hearing impairments that limit participation.\n* Disruptive behavior or other conditions that significantly hinder participation in the rehabilitation program.\n* Active epilepsy or any medical contraindication to physical exercise.\n* Botulinum toxin treatment in the upper limb within the previous 6 months.","ALL","18 Years",{"count":131,"type":132},40,"ESTIMATED","INTERVENTIONAL",[135],"NA","This randomized pilot clinical trial aims to evaluate the effectiveness, feasibility, and cost-effectiveness of a semi-autonomous upper-limb rehabilitation program based on therapeutic exergames in people with Multiple Sclerosis (MS). The intervention integrates intensive motor practice, multisensory feedback, and cognitively demanding tasks to enhance upper-limb function, dexterity, and patient autonomy. Participants will be randomly assigned to either an exergame-based home rehabilitation program with remote physiotherapist supervision or a dose-matched conventional home-based physiotherapy program.\n\nThe primary outcome is upper-limb functionality measured by the Action Research Arm Test (ARAT). Secondary outcomes include motor function, manual ability, quality of life, usability, adherence, and digital performance metrics related to the execution of motor and cognitive tasks. Follow-up at 16 weeks will assess the sustainability of treatment effects.\n\nThis study seeks to generate evidence on whether exergame-based rehabilitation can serve as an accessible, scalable, and patient-centered alternative to conventional home-based upper-limb rehabilitation for individuals with MS.",[138],"Multiple Sclerosis",[138,140,141,142,143,144,145],"Upper Limb Rehabilitation","Exergames","Home-Based Rehabilitation","Virtual Reality Rehablitation","Cost-effectiveness","Usability","NOT_YET_RECRUITING","2026-02-18",{"date":149,"type":150},"2026-02-24","ACTUAL",{"date":152,"type":132},"2026-04",{"date":154,"type":132},"2026-12",{"name":120,"class":6},1]