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NCT Number: NCT07430462

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Europea de Madrid

Villaviciosa de Odón, Madrid, 28670, Spain

Location contact

Marina Castel-Sánchez, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Marina Castel Sánchez

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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