Scale-out of a Home-based Arm and Hand Exercise Program for Stroke: A Multisite Implementation-efficacy Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Fugl Meyer Assessment (upper extremity)
研究概览
简要总结
The goal of this multisite clinal trial is to evaluate the implementation of the home-based Graded Repetitive Arm Supplementary Program (GRASP) at rehabilitation clinics across several hospitals. The main questions it aims to answer is:
• the efficacy of the home-based GRASP program relative to the conventional occupational therapy intervention on improving health outcomes, including UE motor function, daily function, quality of life, and motor control strategies.
Stroke participants will be randomly assigned to either the Home-based GRASP group or the conventional occupational therapy home program group. Each group will undergo an 4 to 6-week intervention (3 sessions/week) with evaluations conducted before, immediately after, and 3 months post-trial, assessing clinical and kinematic measures. Interviews and surveys will be conducted to gain insights into the perspectives of patients regarding the implementation of the home-based GRASP program.
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)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are aged 20 years or older
- •have upper extremity hemiparesis due to the first-ever stroke
- •have some voluntary movement in the affected UE
- •are able to follow 2-step instructions
排除标准
- •orthopedic conditions affecting the arm/hand or other neurological conditions
- •severe pain that prevents movement in the affected arm and hand
- •unstable medical status
结局指标
主要结局
Fugl Meyer Assessment (upper extremity)
时间窗: Baseline, post-test (1 month after baseline), 3-month followup
The FMA-UE is one of the most widely used assessments to quantify UE sensorimotor impairment of the shoulder, elbow, forearm, wrist, and hand. It is based on a 3-point scale (0 cannot perform; 1 can perform partially; 2 can perform fully). The total scores range between 0 and 66, with a higher FMA-UE score indicating less motor impairment.
次要结局
未报告次要终点
研究者
Chieh-ling Yang
Assistant Professor
Chang Gung Memorial Hospital