Heart-Brain Retraining for Stroke Rehabilitation
Heart-Brain Retraining: Forced Aerobic Exercise for Stroke Rehabilitation
研究概览
地位
条件
详细说明
Stroke is the leading cause of disability in the United States with approximately 795,000 new or recurrent strokes per year. An estimated two thirds of patients post-stroke cannot incorporate the affected upper extremity (UE) into their activities of daily living. In addition, stroke survivors experience a 60% decrease in cardiovascular capacity, which contributed to disability and diminished quality of life. Developing rehabilitation techniques to optimize motor recovery while improving cardiovascular endurance would benefit the stroke population.
Animal studies using a forced exercise (FE) paradigm, in which the rodent is exercised on a motorized treadmill at a rate greater than its voluntary rate, indicate an endogenous increase in neurotrophic factors such as brain-derived neurotrophic factor (BDNF) and glial-derived neurotrophic factor (GDNF). These neurotrophic factors are thought to underlie neuroplasticity and motor learning. It is hypothesized that patients with stroke, due to decreased motor cortical output, cannot sustain high rates of voluntary exercise necessary to trigger the endogenous release of neurotrophic factors; therefore, forced-exercise is necessary to augment their voluntary efforts and will be superior to voluntary exercise in facilitating motor recovery. When coupled with repetitive task practice (RTP) of the UE, an effective form of UE rehabilitation, FE will prime the brain for neuroplasticity. We have developed a safe and effective method of delivering forced-exercise to Parkinson's disease (PD) patients (NIH R21HD056316). Clinical and imaging data with PD patients indicate forced-exercise, but not voluntary exercise, triggers a neurophysiologic response in the central nervous system resulting in global improvements in motor and non-motor functioning and increased cortical and subcortical activation. The aim of this project is to conduct a preliminary trial to compare the effects of forced to voluntary exercise when coupled with RTP in promoting the recovery of motor function in patients with stroke.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Able to provide informed consent
- Within 6-12 months of diagnosis of single ischemic or hemorrhagic stroke, confirmed with neuroimaging
- Fugl-Meyer Motor Score 19-55 in involved upper extremity
- Approval from patient's primary care physician
- Age between 18 and 85 years
Exclusion Criteria:
- Hospitalization for myocardial infarction, congestive heart failure, or heart surgery (CABG or valve replacement) within 3 months of study enrollment
- Serious cardiac arrhythmia
- Hypertrophic cardiomyopathy
- Severe aortic stenosis
- Cardiac pacemaker
- Pulmonary embolus
- Other medical or musculoskeletal contraindication to exercise
- Significant cognitive impairment (unable to follow 1-2 step commands) or major psychiatric disorder (major depression, generalized anxiety) that will cause difficulty in study participation
- Anti-spasticity injection (botox) in upper extremity within 3 months of study enrollment
- Pregnancy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Repetitive Task Practice (RTP)
This group focuses on RTP.
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This group will preform arm and hand therapy.
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实验性的:Voluntary cycling + RTP
This group involves one biking session and one RTP session three times per week for eight weeks.
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This group will preform arm and hand therapy and cycle on a bike.
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实验性的:Assisted cycling + RTP
This group involves one biking session and one RTP session three times per week for eight weeks.
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This group will preform arm and hand therapy and cycle on a bike.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Wolf Motor Function Test (WMFT)
大体时间:Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
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This consists of 2 strength tasks and 15 timed tasks of both the affected UE and the unaffected UE.
Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome.
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Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The Fugl-Meyer Assessment (FMA)
大体时间:Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
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This is a 33 item assessment of post-stroke UE impairment.
Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
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Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The Stroke Impact Scale (SIS)
大体时间:Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
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This is a self-reported questionnaire evaluating quality of life.
Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome.
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Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
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合作者和调查者
出版物和有用的链接
一般刊物
- Linder SM, Davidson S, Rosenfeldt A, Lee J, Koop MM, Bethoux F, Alberts JL. Forced and Voluntary Aerobic Cycling Interventions Improve Walking Capacity in Individuals With Chronic Stroke. Arch Phys Med Rehabil. 2021 Jan;102(1):1-8. doi: 10.1016/j.apmr.2020.08.006. Epub 2020 Sep 9.
- Linder SM, Davidson S, Rosenfeldt A, Penko A, Lee J, Koop MM, Phelan D, Alberts JL. Predictors of Improved Aerobic Capacity in Individuals With Chronic Stroke Participating in Cycling Interventions. Arch Phys Med Rehabil. 2020 Apr;101(4):717-721. doi: 10.1016/j.apmr.2019.10.187. Epub 2019 Nov 25.
- Rosenfeldt AB, Linder SM, Davidson S, Clark C, Zimmerman NM, Lee JJ, Alberts JL. Combined Aerobic Exercise and Task Practice Improve Health-Related Quality of Life Poststroke: A Preliminary Analysis. Arch Phys Med Rehabil. 2019 May;100(5):923-930. doi: 10.1016/j.apmr.2018.11.011. Epub 2018 Dec 10.
- Linder SM, Rosenfeldt AB, Rasanow M, Alberts JL. Forced Aerobic Exercise Enhances Motor Recovery After Stroke: A Case Report. Am J Occup Ther. 2015 Jul-Aug;69(4):6904210010p1-8. doi: 10.5014/ajot.2015.015636.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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