Skip to main content
OpenTrials
Completed

NCT Number: NCT02076776

Heart-Brain Retraining for Stroke Rehabilitation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive Task Practice (RTP)

Behavioral

This group will preform arm and hand therapy.

Voluntary cycling + RTP

Behavioral

This group will preform arm and hand therapy and cycle on a bike.

Assisted cycling + RTP

Behavioral

This group will preform arm and hand therapy and cycle on a bike.

Primary outcomes

  1. Wolf Motor Function Test (WMFT)

    Time frame: 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.

Secondary outcomes

  1. The Fugl-Meyer Assessment (FMA)

    Time frame: Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)

    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.

Other outcomes

  1. The Stroke Impact Scale (SIS)

    Time frame: Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)

    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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Heart-Brain Retraining: Forced Aerobic Exercise for Stroke Rehabilitation

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 4, 2014
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.