Home-Based Exergame Rehabilitation for Upper Limb Function in People W

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

Not yet recruitingNot a drug-phase studyMS (type not specified)NCT07430462

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Exergame-Based Upper Limb Rehabilitation Program

Compared with

  • Conventional Home-Based Physiotherapy

What it measured

Main measures

  • Action Research Arm Test (ARAT)

    Baseline (V0), Week 8 (V1), Week 16 (V2)

    Arm and hand function

Other measures (5)

  • EuroQol EQ-5D-5L

    Baseline, Week 8, Week 16

    Quality of life (reported by participants)

  • Wolf Motor Function Test (WMFT)

    Baseline, Week 8, Week 16

    Physical function

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

    Baseline, Week 8, Week 16

    Walking and mobilityArm and hand functionPain

  • ABILHAND Questionnaire

    Baseline, Week 8, Week 16

    Quality of life (reported by participants)

  • Postural Compensations

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

Who could take part

MS (type not specified) · 18 and over · EDSS 2.0 to 6.5

Show the full criteria

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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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History

    1. Started

      Apr 2026

    2. Main results due

      Sept 2026

    3. Finished

      Dec 2026

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