Mechanisms of Response to Locomotor Training After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- The Primary Outcome Measure Was Pre-treatment to Post-treatment Change in Self-selected Walking Speed.
研究概览
简要总结
This is a research study to examine a new type of walking therapy for people after they have had a stroke. We will study how people move and how their muscles work to see how the therapy helps people to walk better and to see how the therapy can be improved.
详细描述
Persons will be asked to walk indoors on a walkway at their own speed and then as fast as they can safely. The walkway measures the speed of their walking and the size of their steps. Participants can use any assistive device that they typically use. A physical therapist will walk beside them as they walk across the walkway. Participants will be asked to walk several times across the walkway for distances of approximately 20 feet each time. If persons meet all the study requirements, they will be scheduled for further testing and for the training. We will contact their physician and inform him/her of their interest in participating in this study and the study criteria for participation. We will need to receive their physician's written medical approval for their participation in this study before we begin the training.
Persons will first have an exercise tolerance test to make sure that it is safe for them to participate in the exercise program that is a part of this study. In the exercise test, they will be asked to ride a stationary bicycle at a specific speed while a cardiologist (a doctor who specializes in testing how well the heart works) or a nurse practitioner with a PhD who specializes in cardiology will monitor their heart rate, blood pressure, the EKG (the electrical signals produced by their heart). The cardiologist or nurse practitioner will conduct, supervise, and interpret findings for the exercise tolerance test. Every minute, the resistance of the bicycle will be increased until their heart rate rises to a certain level. The test will be stopped immediately if they have any atypical or abnormal reactions to the test. If the test has to be stopped for these reasons, we will refer them back to their doctor, and they will not be able to participate in the study. A therapist or research assistant will assist them on and off the bicycle and be sure that they are comfortable.
Clinical Testing. We will first evaluate the severity of their stroke and the effects of their stroke on their ability to move their arms and their legs. Next we will test their walking speed, their balance, their strength, and how much they walk over a typical 4-day period. We will repeat the clinical tests after completion of training, and again 6 months after they finish their training.
Walking Testing: Persons will be asked to wear shorts and low-heeled walking shoes (tennis shoes preferred). Small, dime-sized light-reflecting markers will be placed on their head, shoulder, arm, hand, trunk, hip, knee, ankle, and foot to study and assist in recording the position of their joints while moving. They may be asked to have their muscle activity and leg motions recorded while they walk overground and on the treadmill. For the walking testing, we may need to shave small areas of their legs to attach small sensors to their skin to record activity of their leg muscles. We may also attach small angle measurement devices to the skin over their hips, knee, or ankle joints on their legs. We will film their walking with video cameras. When they are walking, a therapist will guard them or assist as necessary.
They will be asked to begin walking over 1) treadmill and 2) overground at their comfortable speed and as fast as possible. During all treadmill walking, they will wear a harness attached to a mobile device attached to the ceiling. This harness is only used for their safety to prevent a fall (it will catch them should they lose their balance or stumble). However, it will not support any of their weight while they are walking. If they use braces and/or assistive devices, they may be asked to do some walking with and without them, according to their comfort and safety. A therapist will stand beside them to provide any physical assistance they may need.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >= 18,
- •stroke within past 6 months to 5 years,
- •residual paresis in the lower extremity (Fugl-Meyer LE motor score < 34),
- •ability to sit unsupported for 30 seconds,
- •ability to walk at least 10 feet with maximum 1 person assist,
- •self selected 10 meter gait speed less than 0.8 m/s,
- •ability to follow a three step command,
- •provision of informed consent, and
- •successful completion of an exercise tolerance test
排除标准
- •Lived in nursing home prior to stroke,
- •Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking less than 200 meters,
- •Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living). Anyone meeting New York Heart Association criteria for Class 3 or Class 4 heart disease will be excluded,
- •History of serious chronic obstructive pulmonary disease or oxygen dependence,
- •Severe weight bearing pain,
- •Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia, or previous stroke with residual neurological deficits,
- •History of major head trauma,
- •Lower extremity amputation,
- •Non-healing ulcers on the lower extremity,
- •Renal dialysis or end stage liver disease,
- •Legal blindness or severe visual impairment,
- •A history of significant psychiatric illness defined by diagnosis of bipolar affective disorder, psychosis, schizophrenia or medication refractory depression,
- •Life expectancy less than one year,
- •Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10, knee flexion ROM < 90, hip flexion contracture > 25, and ankle plantar flexion contracture > 15,
- •History of sustained alcoholism or drug abuse in the last six months,
- •major post-stroke depression (PHQ-9 10),
- •History of deep venous thrombosis or pulmonary embolism within 6 months,
- •Uncontrollable diabetes with recent weight loss, diabetic coma, or frequent insulin reactions,
- •Severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest,
- •Previous or current enrollment in a clinical trial to enhance stroke motor recovery,
- •Lives more than 50 miles from the training sites,
- •Unable to travel 3 times per week for outpatient training programs, and
- •Intracranial hemorrhage related to aneurysmal rupture or an arteriovenous malformation (hemorrhagic infarctions will not be excluded).
- •Inclusion and Exclusion criteria will be determined by a chart review, depression screen and subject interview by study physician or project coordinator. After initial chart and subject interview, each subject's treating physician will be asked to review our inclusion and exclusion criteria and provide a letter supporting inclusion in the study. All subjects who meet selection criteria must successfully complete an exercise tolerance test.
结局指标
主要结局
The Primary Outcome Measure Was Pre-treatment to Post-treatment Change in Self-selected Walking Speed.
时间窗: Pre and post Treatment
Walking speed is a continuous measure descriptive of overall ambulatory function. This is easily captured with a pressure-sensitive walkway. Three of the 30 participants who completed the study had incomplete data sets, so outcomes are reported on an n=27.
次要结局
未报告次要终点