About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Exergame-Based Upper Limb Rehabilitation Program
- Conventional Home-Based Physiotherapy
Treatment groups
Sponsors and collaborators
Marina Castel Sánchez
Lead sponsor
European University of Madrid
Sponsor institution