Heart-Brain Retraining for Stroke Rehabilitation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Repetitive Task Practice (RTP)

This group focuses on RTP.

Group Type ACTIVE_COMPARATOR

Repetitive Task Practice (RTP)

Intervention Type BEHAVIORAL

This group will preform arm and hand therapy.

Voluntary cycling + RTP

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

Group Type EXPERIMENTAL

Voluntary cycling + RTP

Intervention Type BEHAVIORAL

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

Assisted cycling + RTP

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

Group Type EXPERIMENTAL

Assisted cycling + RTP

Intervention Type BEHAVIORAL

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

Interventions

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Repetitive Task Practice (RTP)

This group will preform arm and hand therapy.

Intervention Type BEHAVIORAL

Voluntary cycling + RTP

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

Intervention Type BEHAVIORAL

Assisted cycling + RTP

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No