Atlantic Canada Modified Constraint Induced Movement Therapy Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change in arm and hand function at 10 weeks, 6 and 12 months relative to baseline performance
研究概览
简要总结
The purpose of this study is to examine the effectiveness and feasibility of a modified constraint induced movement therapy (mCIMT) intervention on upper limb function in two groups of patients acutely post-stroke; 1) an experimental group that will participate in a 10 week mCIMT intervention designed to improve upper limb function, in addition to usual care, and 2) a control group that will participate in a program of usual care consisting of a rehabilitation intervention for the affected upper limb that is dose-matched to the experimental group.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first symptomatic stroke (either ischemic or hemorrhagic) resulting in upper limb hemiparesis
- •the ability to perform a two-step command
- •age ≥ 18 years
- •residence within a 75 km radius of the Queen Elizabeth II Health Sciences Centre
- •with regard to the affected upper limb, subjects will meet standard criteria for modified constraint induced movement therapy (mCIMT) including at least 10 degrees of active wrist extension, at least 10 degrees of thumb abduction/extension, and at least 10 degrees of extension in two additional digits, repeated three times in one minute
排除标准
- •have excessive pain in the affected upper limb (defined as > 4 on a 10 centimeter visual analog scale)
- •presence of dementia or aphasia as defined by a score of < 26 on the Montreal Cognitive Assessment
- •have a diagnosis of pre-stroke dementia
- •have a terminal illness, life-threatening co-morbidity or concomitant neurological or psychiatric illness
- •excessive tone in the upper limb (> 3 on the modified Ashworth Scale)
- •Motor Activity Log score > 2.5 (amount of use sub-scale)
结局指标
主要结局
Change in arm and hand function at 10 weeks, 6 and 12 months relative to baseline performance
时间窗: At 0 weeks, 10 weeks, 6 months and 12 months
Change in arm and hand function will be performed using the Action Research Arm Test, which measures function of the arm and hand using 19 tasks in four different categories (grip, grasp, pinch and gross motor). Performance on each task is scored from 0 (cannot perform any part of the test) to 3 (performs the test normally) for a possible score of 0-57. Improved arm and hand function will be determined by detecting a change in score by comparing performance at each of the post-treatment assessment points (10 weeks, 6 and 12 months) relative to baseline performance.
次要结局
- Change in the quality and amount of arm and hand use at 10 weeks, 6 and 12 months relative to baseline.(At 0 weeks, 10 weeks, 6 months and 12 months)
- Improved return to normal activities in the experimental treatment group as measured by higher scores on the Re-integration to Normal Living Index (RNLI) 6 months post-treatment(At 6 months)
- Change in the amount of use of the arm and hand in everyday life at 10 weeks, 6 and 12 months relative to baseline as detected with accelerometers(At 0 weeks, 10 weeks, 6 months and 12 months)
- Greater satisfaction with treatment compared to the usual care group based on higher scores on the Satisfaction with Stroke Care Questionnaire (SASC-19) in the experimental treatment group(At 10 weeks)
- Improved return to normal activities in the experimental treatment group as measured by higher scores on the Re-integration to Normal Living Index (RNLI) 12 months post-treatment(At 12 months)
研究者
Shaun Boe
Affiliate Scientist
Nova Scotia Health Authority