Effectiveness and Feasibility of a Home-Based Exergame Rehabilitation Protocol for Upper Limb Function in Individuals With Multiple Sclerosis: A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Action Research Arm Test (ARAT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •Provision of written informed consent by the participant or legally authorized representative.
排除标准
- •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.
研究组 & 干预措施
Exergame-Based Semi-Autonomous Program
Participants will complete a semi-autonomous home-based exergame rehabilitation program targeting upper-limb motor and sensory function. The program integrates multisensory feedback, motor sequencing, coordination, and dual-task demands. Remote supervision will be provided by a physiotherapist.
Dose: 30-40 minutes per session, 5 sessions/week for 8 weeks
Mode of Delivery: Home-based with remote monitoring
干预措施: Exergame-Based Upper Limb Rehabilitation Program (Behavioral)
Conventional Physiotherapy Program
Participants will complete an individualized home-based physiotherapy program including strengthening exercises and functional upper-limb tasks, matched in duration and frequency to the experimental arm.
Dose: 30-40 minutes per session, 5 sessions/week for 8 weeks
Mode of Delivery: Home exercise program with standard follow-up
干预措施: Conventional Home-Based Physiotherapy (Behavioral)
结局指标
主要结局
Action Research Arm Test (ARAT)
时间窗: 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.
次要结局
- EuroQol EQ-5D-5L(Baseline, Week 8, Week 16)
- Wolf Motor Function Test (WMFT)(Baseline, Week 8, Week 16)
- Fugl-Meyer Assessment for Upper Extremity (FMA-UE)(Baseline, Week 8, Week 16)
- ABILHAND Questionnaire(Baseline, Week 8, Week 16)
- Postural Compensations(During each training session across the 8-week intervention period.)
研究者
Marina Castel Sánchez
Associate Professor
European University of Madrid