A Motor Learning Based Walking Program Versus Body Weight Supported Treadmill Training in Community Dwelling Adults Within One Year of Stroke Onset: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Self selected over ground gait speed - 5 metre walk test
研究概览
简要总结
Stroke is a major cause of disability in Canadian adults. Following a stroke, many people have difficulty walking in their home and in the community. The purpose of this study is to compare the effect of two different approaches to walking retraining in people who have had a stroke.
Individuals living in the community who have had recently had a stroke will be asked to participate in this study. Participants will be randomly assigned to one of two five week walking training programs. In one program, individuals will re-learn to walk in a variety of real-life situations. Practice sessions will encourage active problem solving by the participants. The other program will have participants practice walking on a treadmill while some of their body weight is supported by a special harness system. Participants will also be assisted by a physiotherapist to walk in a more normal manner.
Participants' will be assessed at the beginning of the study, after the 5 week training program and again, eight weeks later. The research assistant will assess their ability to walk, their confidence level and the average daily walking activity.
Primary Hypothesis: Individuals assigned to the Motor Learning Walking Program will improve their walking ability from baseline to follow up assessment significantly more than individuals assigned to the Treadmill Training Program.
The results of this study will help physiotherapists plan effective treatment programs for individuals with walking difficulties following stroke. It will also give researchers direction for future studies in the areas of walking retraining and motor skill development post-stroke.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke onset within previous 12 months
- •Age 40 or older
- •Able to follow 2 step verbal command (English),
- •Able to walk 10 metres without human assistance (may use walking aid)
- •Independent community ambulatory prior to stroke
- •Community dwelling
- •Approval from physician for participation in study
排除标准
- •Walking speed greater than 1.0 m/s without walking aid
- •Within normal limits on Modified Mini Mental Status test (age and education adjusted)
- •Documented global aphasia
- •Legal blindness
- •Unable to exercise due to the any of the following conditions
- •A recent significant change in resting ECG suggesting ischemia
- •Recent Myocardial infarction (within 3 months) or other acute cardiac event
- •Unstable angina
- •Severe SOB at rest or with activities of daily living
- •Uncontrolled cardiac arrhythmias causing symptoms
- •Severe symptomatic aortic stenosis
- •Uncontrolled symptomatic heart failure
- •Acute pulmonary embolus or pulmonary infarction
- •Acute myocarditis or pericarditis
- •Suspected or known dissecting aneurysm
- •Acute systemic infection, accompanied by fever, body ache or swollen lymph glands
- •Uncontrolled hypertension (systolic > 200 mmHg, diastolic > 110 mmHg )
- •Severe peripheral vascular disease with sustained claudication (resulting in limited walking tolerance)
- •Severe lower extremity orthopedic problems with severe pain on weight bearing
- •Lower extremity amputation that requires prosthesis
研究组 & 干预措施
Motor Learning Walking Program
Motor Learning principles based Walking Program (MLWP) Participants practice variety of real life over ground walking related activities. Order of practice, instructions, guidance and feedback are provided in a manner that facilitates cognitive engagement of learner.
干预措施: Motor Learning Walking Program (Behavioral)
Body weight supported treadmill training
Body Weight Supported Treadmill Training. Participants walk on a treadmill while partially supported with an overhead harness system. Mass repetition of the normal gait cycle is encouraged through the support of the harness, the movement of the treadmill, and the assistance of one or two trainers to position limbs and trunk.
干预措施: Body Weight Supported Treadmill Training (Behavioral)
结局指标
主要结局
Self selected over ground gait speed - 5 metre walk test
时间窗: 8 week follow up
次要结局
- Number of trainers required per treatment session(Documented at every treatment session for both experimental and active comparison interventions.)
- Six Minute Walk Test(Post Intervention and 8 week follow up)
- Dynamic Balance - Functional Balance Test(Baseline, Post-intervention and 8 week Follow-up)
- Patient Specific Functional Scale(Baseline, Post-intervention, Follow-up (8weeks))
- Balance related Self Efficacy - Activities-specific Balance Confidence Scale(Post intervention and 8 week follow up)
- Average Daily Step Count - StepWatch 3 Step Activity Monitor(Post Intervention and 8 Week Follow up)
- Adverse event - Falls (yes or no)(Follow - up - 8 weeks after post-intervention assessment)
- Self selected over ground gait speed - 5 metre walk test(Post Intervention)
- Life Space Questionnaire(Baseline, Post-intervention, and at 8 week follow up)
- Adverse event - Self-report of a fall(s) since baseline assessment(Post Intervention Assessment)
- Serious adverse events - ie. new stroke, myocardial infarction, overnight hospital admission, death(Post-intervention, Follow up (8 weeks))
- Rating of Walking functional level - Modified Functional Walking Categories(Baseline, Post-intervention, Follow-up (8 weeks))
研究者
Vince DePaul
Physiotherapist (PT), PhD (candidate)
McMaster University