Stroke Inpatient Rehabilitation Reinforcement of Walking Speed
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 29
- 主要终点
- Gait speed
研究概览
简要总结
The primary purpose of this study is to determine the effects of reinforcement of walking speed on recovery of walking speed over the course of inpatient rehabilitation for people after stroke. The study will also examine the relationship between short distance walking speed and walking distance over a fixed time.
详细描述
This study is a single-blind, randomized, multi-center trial design. People who are admitted post-stroke for inpatient rehabilitation will be examined for eligibility by the treating physician. Subjects who satisfy the selection criteria and who agree to participate will be randomized to either the experimental group or the control group.
Intervention
All subjects will receive usual therapy during their inpatient rehabilitation stay.
Subjects in the experimental group (Daily Reinforcement of Speed or DRS group) will receive encouragement to walk faster with feedback on their performance every day for the duration of their inpatient stay. During one of the daily therapy sessions (preferably morning), the experimental subjects will be encouraged by their physical therapist to walk at least 10 m (25 feet) along a straight hallway. Subjects in the experimental group will be timed with a stopwatch by their treating physical therapist each day during the 10-meter walking task. If a subject is not able to walk 10 meters, then a shorter distance is used until the 10-meter distance can be achieved (if possible). Before starting the timed walk, the therapist will remind the subject to "walk as fast as safely possible" and to try to walk the distance "a few seconds faster than what you were able to do in the past few days". The therapist can provide the assistance of another person and use aids, and whatever is needed for safety. The timed test should be stopped or not performed on any one day if this is best for patient care. The subject's safety must not be compromised. At the end of the timed walk, the therapist will provide the results for that day in a positive tone, such as "Very good! You walked that in xx seconds". Then, (a) 'This is better by x seconds', or (b) 'This shows you are holding your own', or (c) 'I believe that you will soon be able to walk a bit faster with a better walking pattern'."
Subjects who are randomized to the control group (No Reinforcement of Speed or NRS group) will not be timed during a daily 10-meter walk, nor specifically encouraged to walk faster each day.
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
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •35 years or older
- •suffered a stroke from any cause that is unlikely to progress or recur within 2 years of onset (thrombotic infarct, cardioembolus, intracerebral hemorrhage)
- •unilateral hemiparesis with strength of the proximal leg muscles ≤4/5
- •able to follow simple instructions and understand verbal reinforcement about walking speed
- •able to take 5 steps with not more than the assistance of one person
排除标准
- •premorbid walking difficulty in the community, such as a prior stroke with residual impairment, arthritis with pain on stepping, dyspnea or angina on modest exertion, limited walking endurance due to cardiopulmonary or other disease
- •history of dementia
- •current medical disease that will limit physical therapy at the time of randomization, such as critical illness myopathy/neuropathy, serious infection, thrombophlebitis, orthostatic hypertension, decubitus ulcer, congestive heart failure, chronic obstructive lung disease, organ transplantation, recent surgery (including coronary bypass), or pain with weigh bearing
结局指标
主要结局
Gait speed
时间窗: Admission, 2 weeks, 4 weeks, 6 weeks, 8 weeks, discharge, 3 months, 6 months
次要结局
- Distance walked in 3 minutes(4 weeks, discharge, 3 months, 6 months)
- Functional Ambulation Classification (FAC)(Admission, 2 weeks, 4 weeks, 6 weeks, 8 weeks, discharge, 3 months, 6 months)
- Number of falls post inpatient rehabilitation(3 months, 6 months)