Constraint Induced Movement Therapy for Walking in Individuals Post Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in walking speed
研究概览
简要总结
To compare the effect of constraint induced movement therapy (CIMT) vs. treadmill training only on walking function in individuals post-stroke, a 6 week, single-blind, randomized training study will be conducted with three assessments of gait to determine the training effect. Subjects will be randomized to either the CIMT or treadmill training only groups at the initial test. Following the initial test, individuals from the 2 groups will undergo intensive locomotor training. Training will be performed 3 times per week for 6 weeks with the training time for each visit set to 45 minutes as tolerated. Data collection will proceed until 36 subjects from 2 groups have been trained.
详细描述
To determine the effect of constraint induced movement therapy (CIMT) on locomotor function in individuals post stroke. In order to compare the effect of CIMT vs. treadmill training only on walking function in individuals post-stroke, a 6 week, single-blind, randomized training study will be conducted with three assessments of gait to determine the training effect. Subjects will be blocked by gait speed into slow (< 0.4 m/s) or fast (≥ 0.4 m/s) subgroups and randomized to either the CIMT or treadmill training only groups at the initial test. Following the initial test, individuals from the 2 groups will undergo intensive locomotor training. Training will be performed 3 times per week for 6 weeks with the training time for each visit set to 45 minutes as tolerated, excluding set up time. Data collection will proceed until 36 subjects from 2 groups have been trained.
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 measures of each subject will be evaluated before training, after 6 weeks of training, and at 8 weeks after the end of training by a physical therapist who is blinded by subject group assignment, and subjects will be requested not to disclose his/her group assignment to this physical therapist.
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 21 and 75 years;
- •history of unilateral, supratentorial, ischemic or hemorrhagic stroke;
- •no prior stroke;
- •demonstration of impaired walking function (self-selected walking speed ≤ 0.80 m/s);
- •able to stand and walk (>10 meters) without physical assistance.
排除标准
- •significant cardiorespiratory/metabolic disease;
- •other neurological or orthopedic injury that impairs locomotion;
- •scores on the Mini Mental Status examination < 24;
- •stroke of the brainstem or cerebellar lesions;
- •uncontrolled hypertension (systolic > 200 mm Hg, diastolic > 110 mm Hg);
- •botox injection within 6 months of starting the study.
结局指标
主要结局
Change in walking speed
时间窗: pre, post 6 weeks training, and 8 weeks after the end of training.
Overground gait speed will be collected on a 10 m instrumented walkway
Change in 6-minute walking distance
时间窗: pre, post 6 weeks training, and 8 weeks after the end of training.
walking distance covered by subjects in 6 minutes
次要结局
- Change in Berg Balance Scale(pre, post 6 weeks training, and 8 weeks after the end of training.)
研究者
Ming Wu
Research Scientist
Shirley Ryan AbilityLab