跳至主要内容
临床试验/NCT02076776
NCT02076776已完成不适用

Heart-Brain Retraining: Forced Aerobic Exercise for Stroke Rehabilitation

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2012年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Wolf Motor Function Test (WMFT)

研究概览

简要总结

The purpose of this study is to gain a better understanding of how different types of exercise can help people after a stroke. The investigators want to study if different types of exercise will improve the use of arm and hand function after a stroke.

详细描述

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
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Repetitive Task Practice (RTP)

Active Comparator

This group focuses on RTP.

干预措施: Repetitive Task Practice (RTP) (Behavioral)

Voluntary cycling + RTP

Experimental

This group involves one biking session and one RTP session three times per week for eight weeks.

干预措施: Voluntary cycling + RTP (Behavioral)

Assisted cycling + RTP

Experimental

This group involves one biking session and one RTP session three times per week for eight weeks.

干预措施: Assisted cycling + RTP (Behavioral)

结局指标

主要结局

Wolf Motor Function Test (WMFT)

时间窗: Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)

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.

次要结局

  • The Fugl-Meyer Assessment (FMA)(Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jay Alberts

Principle Investigator

The Cleveland Clinic

研究点 (2)

Loading locations...

相似试验