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Heart-Brain Retraining for Stroke Rehabilitation

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive Task Practice (RTP)
Voluntary cycling + RTP
Assisted cycling + RTP
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Exercise, Rehabilitation, Neuroplasticity, Task Practice

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Repetitive Task Practice (RTP)

Voluntary cycling + RTP

Assisted cycling + RTP

Arm Description

This group focuses on RTP.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 24, 2014
Last Updated
August 2, 2018
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02076776
Brief Title
Heart-Brain Retraining for Stroke Rehabilitation
Official Title
Heart-Brain Retraining: Forced Aerobic Exercise for Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Exercise, Rehabilitation, Neuroplasticity, Task Practice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Repetitive Task Practice (RTP)
Arm Type
Active Comparator
Arm Description
This group focuses on RTP.
Arm Title
Voluntary cycling + RTP
Arm Type
Experimental
Arm Description
This group involves one biking session and one RTP session three times per week for eight weeks.
Arm Title
Assisted cycling + RTP
Arm Type
Experimental
Arm Description
This group involves one biking session and one RTP session three times per week for eight weeks.
Intervention Type
Behavioral
Intervention Name(s)
Repetitive Task Practice (RTP)
Intervention Description
This group will preform arm and hand therapy.
Intervention Type
Behavioral
Intervention Name(s)
Voluntary cycling + RTP
Intervention Description
This group will preform arm and hand therapy and cycle on a bike.
Intervention Type
Behavioral
Intervention Name(s)
Assisted cycling + RTP
Intervention Description
This group will preform arm and hand therapy and cycle on a bike.
Primary Outcome Measure Information:
Title
Wolf Motor Function Test (WMFT)
Description
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.
Time Frame
Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
Secondary Outcome Measure Information:
Title
The Fugl-Meyer Assessment (FMA)
Description
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.
Time Frame
Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
Other Pre-specified Outcome Measures:
Title
The Stroke Impact Scale (SIS)
Description
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.
Time Frame
Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Alberts, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32918907
Citation
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.
Results Reference
derived
PubMed Identifier
31778659
Citation
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.
Results Reference
derived
PubMed Identifier
30543801
Citation
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.
Results Reference
derived
PubMed Identifier
26114455
Citation
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.
Results Reference
derived

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Heart-Brain Retraining for Stroke Rehabilitation

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