Heart-Brain Retraining for Stroke Rehabilitation

Stroke Clinical Trial

Official title:

Heart-Brain Retraining: Forced Aerobic Exercise for Stroke Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076776
• Other study ID #: R03HD073566
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: November 2014

Study information

• Verified date: August 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Repetitive Task Practice (RTP)
This group will preform arm and hand therapy.
• Voluntary cycling + RTP
This group will preform arm and hand therapy and cycle on a bike.
• Assisted cycling + RTP
This group will preform arm and hand therapy and cycle on a bike.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Stroke Impact Scale (SIS)	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.	Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
Primary	Wolf Motor Function Test (WMFT)	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.	Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
Secondary	The Fugl-Meyer Assessment (FMA)	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.	Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)