Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Upper Limb Rehabilitation, Exergames, Home-Based Rehabilitation, Virtual Reality Rehablitation, Cost-effectiveness, Usability
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.
Interventions
BEHAVIORALExergame-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.
BEHAVIORALConventional 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.
Sponsors
Marina Castel Sánchez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test (ARAT) | 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
| Measure | Time frame | Description |
|---|---|---|
| EuroQol EQ-5D-5L | 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. |
| Wolf Motor Function Test (WMFT) | 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. |
| Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | 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. |
| ABILHAND Questionnaire | 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. |
| Postural Compensations | 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. |
Countries
Spain
Outcome results
None listed