A Randomized Controlled Trial Assessing the Efficacy, Feasibility, and Usability of an Exergame-Based Semi-Autonomous Upper-Limb Rehabilitation Program in Individuals With Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 主要终点
- Upper-Limb Functionality (Action Research Arm Test, ARAT)
研究概览
简要总结
This study is a randomized controlled trial designed to evaluate the effectiveness of a semi-autonomous upper-limb rehabilitation program based on exergames in adults with chronic stroke. Participants will be randomly assigned (1:1) to either an exergame-based intervention or an individually delivered conventional home-based therapy program. The primary outcome is upper-limb functionality as measured by the Action Research Arm Test (ARAT). Secondary outcomes include upper-limb motor function and quality of life. The study also examines adherence, usability, and the feasibility of remote monitoring for long-term implementation.
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 assignment throughout the study.
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
- •Adults aged 18 years or older.
- •Confirmed diagnosis of chronic stroke with more than 6 months of evolution.
- •Ability to maintain independent sitting and standing (with or without assistive devices).
- •Upper-limb functional capacity ranging from limited to moderate, defined as an ARAT score between 11 and 54 points.
- •Ability to understand and follow simple instructions (Mini-Mental State Examination ≥ 23).
- •Ability to provide informed consent personally or through a legal representative.
排除标准
- •Acute illness, musculoskeletal pathology, or pain that interferes with the performance of rehabilitation exercises.
- •Uncompensated sensory deficits, including significant visual or hearing impairments.
- •Disruptive behavior or neuropsychiatric conditions that may limit participation.
- •Active epilepsy or any medical contraindication to physical exercise.
- •Botulinum toxin treatment affecting the upper limb within the previous 6 months.
研究组 & 干预措施
Exergame-Based Rehabilitation
Participants assigned to the experimental group will complete a semi-autonomous upper-limb rehabilitation program based on exergames. The intervention includes task-oriented, progressive training targeting upper-limb motor function, visuomotor coordination, and cognitive engagement (e.g., attention, decision-making). Difficulty is adjusted individually based on performance, and sessions are remotely monitored by clinicians.
干预措施: Exergame-Based Upper-Limb Training (Behavioral)
Conventional Home-Based Rehabilitation
Participants in the control group will receive an individualized home-based upper-limb rehabilitation program delivered through conventional therapeutic exercises equivalent in duration and content focus (motor control, coordination, precision). The intervention is prescribed by a therapist and supervised periodically, without digital gaming components.
干预措施: Conventional Individual Rehabilitation (Behavioral)
结局指标
主要结局
Upper-Limb Functionality (Action Research Arm Test, ARAT)
时间窗: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2)
The ARAT assesses upper-limb functionality through 19 tasks categorized into grasp, grip, pinch, and gross movement. It provides a standardized, performance-based measure of upper-limb motor ability in individuals with stroke.
次要结局
- Health-Related Quality of Life (EQ-5D-5L)(Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2).)
- Upper-Limb Functional performance (Wolf Motor Function Test, WMFT)(Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2).)
- Upper-Limb Motor Function (Fugl-Meyer Assessment for Upper Extremity, FMA-UE)(Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2).)
- Perceived Manual Function (ABILHAND Questionnaire)(Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2))
研究者
Marina Castel Sánchez
Associate Professor
European University of Madrid