Home-Based Exergame Rehabilitation for Upper Limb Function in People With Multiple Sclerosis

February 18, 2026 updated by: Marina Castel Sánchez

Effectiveness and Feasibility of a Home-Based Exergame Rehabilitation Protocol for Upper Limb Function in Individuals With Multiple Sclerosis: A Randomized Controlled Pilot Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Clinical diagnosis of Multiple Sclerosis with EDSS score between 2.0 and 6.5, with upper-limb involvement.
  • Ability to maintain independent sitting and to stand with or without assistive devices.
  • Upper-limb functional capacity between 11 and 54 points on the ARAT, indicating limited to substantial impairment.
  • Cognitive ability to understand and follow simple instructions, demonstrated by a Mini-Mental State Examination score ≥ 23.
  • Provision of written informed consent by the participant or legally authorized representative.

Exclusion Criteria:

  • Acute illness, musculoskeletal injury, or pain interfering with the ability to perform the intervention exercises.
  • Uncompensated visual or hearing impairments that limit participation.
  • Disruptive behavior or other conditions that significantly hinder participation in the rehabilitation program.
  • Active epilepsy or any medical contraindication to physical exercise.
  • Botulinum toxin treatment in the upper limb within the previous 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exergame-Based Semi-Autonomous Program

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.

Dose: 30-40 minutes per session, 5 sessions/week for 8 weeks

Mode of Delivery: Home-based with remote monitoring
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.

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.
Active Comparator: Conventional Physiotherapy Program

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.

Dose: 30-40 minutes per session, 5 sessions/week for 8 weeks

Mode of Delivery: Home exercise program with standard follow-up
Behavioral: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Action Research Arm Test (ARAT)
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.
Baseline (V0), Week 8 (V1), Week 16 (V2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postural Compensations
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.
During each training session across the 8-week intervention period.
EuroQol EQ-5D-5L
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.
Baseline, Week 8, Week 16
Wolf Motor Function Test (WMFT)
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.
Baseline, Week 8, Week 16
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
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.
Baseline, Week 8, Week 16
ABILHAND Questionnaire
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.
Baseline, Week 8, Week 16

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction (5-point Likert Scale)
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.
Week 8
Adherence to the Rehabilitation Program
Time Frame: Throughout the 8-week intervention
Percentage of completed sessions out of the prescribed 40 sessions. Adherence ≥80% is considered adequate.
Throughout the 8-week intervention
Effective Practice Dose
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.
Each session (summed across intervention period, up to 8 weeks)
Movement Accuracy
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.
During each training session during the 8week-intervention program
Perceived Effort (Modified Borg Scale 0-10)
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.
End of each session (up to 40 minutes)
Professional Workload
Time Frame: Each session across the 8 week-intevention program
Total number of minutes the physiotherapist dedicates to preparing, supervising, and documenting each session.
Each session across the 8 week-intevention program
Usability (System Usability Scale, SUS)
Time Frame: Week 8
Assesses usability of the exergame system. Scores range from 0 to 100. Higher scores indicate better usability.
Week 8
Social Value
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.
Week 8 and Week 16
Cost-Effectiveness
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.
Week 8 and Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marina Castel Sánchez

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEUROREAVIRTEM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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