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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repetitive Task Practice (RTP) | Active Comparator | This group focuses on RTP. |
|
| Voluntary cycling + RTP | Experimental | This group involves one biking session and one RTP session three times per week for eight weeks. |
|
| Assisted cycling + RTP | Experimental | This group involves one biking session and one RTP session three times per week for eight weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Task Practice (RTP) | Behavioral | This group will preform arm and hand therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Alberts, PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32918907 | Derived | 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. | |
| 31778659 | Derived | 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. |
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One participant consented to the study, but had abnormal stress test results. This participant declined follow-up care and withdrew from the study before completing the baseline and randomization process.
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| ID | Title | Description |
|---|---|---|
| FG000 | Repetitive Task Practice (RTP) | This group focuses on RTP. Repetitive Task Practice (RTP): This group will preform arm and hand therapy. |
| FG001 | Voluntary Cycling + RTP | This group involves one biking session and one RTP session three times per week for eight weeks. Voluntary cycling + RTP: This group will preform arm and hand therapy and cycle on a bike. |
| FG002 | Assisted Cycling + RTP | This group involves one biking session and one RTP session three times per week for eight weeks. Assisted cycling + RTP: This group will preform arm and hand therapy and cycle on a bike. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Repetitive Task Practice (RTP) | This group focuses on RTP. Repetitive Task Practice (RTP): This group will preform arm and hand therapy. |
| BG001 | Voluntary Cycling + RTP | This group involves one biking session and one RTP session three times per week for eight weeks. Voluntary cycling + RTP: This group will preform arm and hand therapy and cycle on a bike. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Repetitive Task Practice (RTP) | This group focuses on RTP. Repetitive Task Practice (RTP): This group will preform arm and hand therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrent stroke | General disorders | Non-systematic Assessment | One participant had a fatal recurrent stroke approximately 36 hours after the intervention. Upon reviewing the subject's medical history and stress test, the Patient Safety Monitoring Board unanimously concluded it was not due to the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jay Alberts | Cleveland Clinic | 216 445-3222 | albertj@ccf.org |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C102600 | N-myc downstream-regulated gene 1 protein |
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| 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. |
|
| 30543801 | Derived | 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. |
| 26114455 | Derived | 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. |
| BG002 | Assisted Cycling + RTP | This group involves one biking session and one RTP session three times per week for eight weeks. Assisted cycling + RTP: This group will preform arm and hand therapy and cycle on a bike. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Wolf Motor Function Test | Upper extremity function test. Total Functional Ability Score is reported. Scores range from 0-75 and higher scores indicate better function. | Mean | Standard Deviation | units on a scale |
|
| Fugl-Meyer Assessment | Upper extremity motor test. Total score is reported. Scores range from 0-66 and higher scores indicate less impairment. | Mean | Standard Deviation | units on a scale |
|
| Stroke Impact Scale | Quality of life questionnaire. Normalized Hand Function score is reported. Scores range from 0-100, with higher values indicating better self-reported quality of life. | Mean | Standard Deviation | units on a scale |
|
| OG002 | Assisted Cycling + RTP | This group involves one biking session and one RTP session three times per week for eight weeks. Assisted cycling + RTP: This group will preform arm and hand therapy and cycle on a bike. |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks) |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Voluntary Cycling + RTP | This group involves one biking session and one RTP session three times per week for eight weeks. Voluntary cycling + RTP: This group will preform arm and hand therapy and cycle on a bike. | 1 | 8 | 1 | 8 | 0 | 8 |
| EG002 | Assisted Cycling + RTP | This group involves one biking session and one RTP session three times per week for eight weeks. Assisted cycling + RTP: This group will preform arm and hand therapy and cycle on a bike. | 0 | 6 | 0 | 6 | 0 | 6 |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
|
| EOT+4 |
|
|
| EOT+4 |
|