Universidad Europea de Madrid
Villaviciosa de Odón, Madrid, 28670, Spain
NCT Number: NCT07430462
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.
The 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.
This 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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Villaviciosa de Odón, Madrid, 28670, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Dose and Schedule:
5 sessions per week 30-40 minutes per session Duration: 8 weeks
Mode of Delivery:
Home-based training using therapeutic exergames, with remote monitoring and session review by a physiotherapist.
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.
Dose and Schedule:
5 sessions per week 30-40 minutes per session Duration: 8 weeks
Mode of Delivery:
Home-based exercises with standard clinical follow-up and therapist support as needed.
Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)
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.
Time frame: Baseline, Week 8, Week 16
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.
Time frame: Baseline, Week 8, Week 16
Assesses upper-limb motor performance through timed tasks and strength measures. Scores range from 0 to 75, with higher scores indicating better motor function.
Time frame: Baseline, Week 8, Week 16
Evaluates motor function, sensation, passive joint mobility, and joint pain. Total scores range from 0 to 66, with higher scores indicating better motor recovery.
Time frame: Baseline, Week 8, Week 16
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.
Time frame: During each training session across the 8-week intervention period.
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.
Time frame: Throughout the 8-week intervention
Percentage of completed sessions out of the prescribed 40 sessions. Adherence ≥80% is considered adequate.
Time frame: Each session (summed across intervention period, up to 8 weeks)
Total minutes of active motor or cognitive task execution, recorded by the physiotherapist.
Time frame: During each training session during the 8week-intervention program
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.
Time frame: End of each session (up to 40 minutes)
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.
Time frame: Each session across the 8 week-intevention program
Total number of minutes the physiotherapist dedicates to preparing, supervising, and documenting each session.
Time frame: Week 8
Assesses usability of the exergame system. Scores range from 0 to 100. Higher scores indicate better usability.
Time frame: Week 8 and Week 16
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.
Time frame: Week 8
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.
Time frame: Week 8 and Week 16
Cost-effectiveness will be evaluated by calculating the Incremental Cost-Effectiveness Ratio (ICER), expressed as cost per quality-adjusted life year (€/QALY) 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.
Marina Castel Sánchez
Other
Effectiveness and Feasibility of a Home-Based Exergame Rehabilitation Protocol for Upper Limb Function in Individuals With Multiple Sclerosis: A Randomized Controlled Pilot Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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