Effects of Repetition Home-based Constraint Induced Movement Therapy (CIMT) Compared With Repetition Clinic-based CIMT on Outcomes Post Stroke: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- upper limb Fugl Meyer motor assessment
研究概览
简要总结
Constraint induced movement therapy (CIMT) is based on the theoretical basis that constraining the unaffected limb following injury of the brain such as stroke can help overcome learned non-use. It comprises of constraint of the unaffected limb, massed tasks practice with the affected limb and a behavioral contract known as the transfer package whereby use of the affected limb is extended to the real-world situations. home-based rehabilitation is likely to be cost-effective, and it may reduce cost for patients in terms of hospital charges and transport fares. However, one of the major problems with the existing home-based CIMT protocols is that, they used number of hours spent carrying out tasks practice as the measure of intensity of practice, and it has been argued that, such method is not clear and it does not reflect the correct intensity of practice.
详细描述
The aim of this study is to determine the effects of home-based CIMT compared with clinic-based CIMT that use number of repetition of tasks practice on motor impairment, motor function, quantity and quality of use of the limb in everyday life, community integration, stroke self-efficacy and quality of life. Constraint induced movement therapy (CIMT) can be administered either at home or in the clinic. The home-based CIMT is used to make CIMT easier for the patients
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have stroke 1-2 years before
- •moderate disability
- •a score of 1 to 3 on the motor arm item of the National Institutes of Health Stroke Scale (NIHSS)
- •a score of 3 or more on the upper arm item of the Motor Assessment Scale (MAS)
- •no significant cognitive impairment (a score of ≥24 points on Minimental state examination)
排除标准
- •patients with re-stroke
- •serious orthopaedic conditions such joint contracture, osteoarthritis and burns that will interfere with carrying out CIMT
- •who are receiving rehabilitation at the time of the study
结局指标
主要结局
upper limb Fugl Meyer motor assessment
时间窗: 3 months follow up
valid and reliable instrument that assesses motor impairment following stroke . Items in the instrument are scored on a scale between 0 and 2, with a score 0 indicating cannot perform, a score of 1 indicating performs partially, and a score of 2 indicating performs fully. Scores obtained from the instrument can range from 0 to 66, with higher scores denoting higher ability.
Wolf motor function test (WMFT)
时间窗: 3 months follow up
valid and reliable tool comprising of 17 items that assess motor function of the upper limb following stroke. Each of the items is rated on a scale of zero to 5, with higher scores denoting higher motor function. Similarly, the MAL is a valid and reliable instrument comprising of 30 items that separately assess quantity and quality of the use of upper extremity in real world following a stroke. Each of the items contained in the instrument are rated on a scale of zero to 5, with higher scores denoting higher quantity or quality of use of the limb in the real world.
motor activity log (MAL)
时间窗: 3 months follow up
valid and reliable instrument comprising of 30 items that separately assess quantity and quality of the use of upper extremity in real world following a stroke. Each of the items contained in the instrument are rated on a scale of zero to 5, with higher scores denoting higher quantity or quality of use of the limb in the real world.
community integration measure (CIM)
时间窗: 3 months follow up
valid and reliable 10-item measure of social interactions following a disease or illness. Each item is rated on a 5 point scale, with possible scores ranging from 0 to 50.
stroke self-efficacy questionnaire (SSEQ)
时间窗: 3 months follow up
The SSEQ is a valid and reliable measure of how confident patients with stroke are in carrying out activities of daily living. The most recent version of the questionnaire is scored on a scale of 0 to 3, with higher scores denoting increasing confidence.
stroke specific quality of life (SSQoL)
时间窗: 3 months follow up
valid and reliable measure of quality of life specifically for patients with stroke. It consists of 49 items measuring 12 domains.
次要结局
未报告次要终点
研究者
Shamay Ng
Professor
The Hong Kong Polytechnic University