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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Exergame-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 minut
• Поведенческое Conventional 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.

Первичные конечные точки

• Action Research Arm Test (ARAT) [Срок оценки: Baseline (V0), Week 8 (V1), Week 16 (V2)]

Вторичные конечные точки (5)

• EuroQol EQ-5D-5L [Срок оценки: Baseline, Week 8, Week 16]
• Wolf Motor Function Test (WMFT) [Срок оценки: Baseline, Week 8, Week 16]
• Fugl-Meyer Assessment for Upper Extremity (FMA-UE) [Срок оценки: Baseline, Week 8, Week 16]
• ABILHAND Questionnaire [Срок оценки: Baseline, Week 8, Week 16]
• Postural Compensations [Срок оценки: During each training session across the 8-week intervention period.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Universidad Europea de Madrid — Villaviciosa de Odón

Идентификаторы

NCT: NCT07430462 · NEUROREAVIRTEM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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