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

NCT07430462 | Not Yet Recruiting

• 1 other identifier: NEUROREAVIRTEM
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Upper Limb Rehabilitation; Exergames; Home-Based Rehabilitation; Virtual Reality Rehablitation; Cost-effectiveness; Usability

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• EuroQol EQ-5D-5L

  Baseline, Week 8, Week 16

• Wolf Motor Function Test (WMFT)

  Baseline, Week 8, Week 16

• Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

  Baseline, Week 8, Week 16

• ABILHAND Questionnaire

  Baseline, Week 8, Week 16

• Postural Compensations

  During each training session across the 8-week intervention period.

Other Outcomes (9)

• Adherence to the Rehabilitation Program

  Throughout the 8-week intervention

• Effective Practice Dose

  Each session (summed across intervention period, up to 8 weeks)

• Movement Accuracy

  During each training session during the 8week-intervention program

Study Arms (2)

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. 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

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. 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

Interventions

Exergame-Based Upper Limb Rehabilitation Program BEHAVIORAL

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.

Exergame-Based Semi-Autonomous Program

Conventional Home-Based Physiotherapy BEHAVIORAL

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.

Conventional Physiotherapy Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marina Castel Sánchez: lead

Study Sites (1)

Universidad Europea de Madrid

Villaviciosa de Odón, Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

ES (1)