Stroke
Conditions
Keywords
Stroke, Exercise, Rehabilitation, Neuroplasticity, Task Practice
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.
Interventions
BEHAVIORALRepetitive Task Practice (RTP)
This group will preform arm and hand therapy.
BEHAVIORALVoluntary cycling + RTP
This group will preform arm and hand therapy and cycle on a bike.
BEHAVIORALAssisted cycling + RTP
This group will preform arm and hand therapy and cycle on a bike.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wolf Motor Function Test (WMFT) | 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
| Measure | Time frame | Description |
|---|---|---|
| The Fugl-Meyer Assessment (FMA) | 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
| Measure | Time frame | Description |
|---|---|---|
| The Stroke Impact Scale (SIS) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Repetitive Task Practice (RTP) This group focuses on RTP.
Repetitive Task Practice (RTP): This group will preform arm and hand therapy. | 6 |
| 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. | 8 |
| 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. | 6 |
| Total | 20 |
Baseline characteristics
| Characteristic | Voluntary Cycling + RTP | Repetitive Task Practice (RTP) | Total | Assisted Cycling + RTP |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 4 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 16 Participants | 6 Participants |
| Age, Continuous | 59.38 years STANDARD_DEVIATION 15.57 | 61.67 years STANDARD_DEVIATION 7.45 | 55.70 years STANDARD_DEVIATION 13.94 | 44.83 years STANDARD_DEVIATION 11.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 6 Participants | 20 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fugl-Meyer Assessment | 34.75 units on a scale STANDARD_DEVIATION 13.58 | 26.83 units on a scale STANDARD_DEVIATION 7.83 | 32.80 units on a scale STANDARD_DEVIATION 10.72 | 36.17 units on a scale STANDARD_DEVIATION 7.41 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 4 Participants | 13 Participants | 3 Participants |
| Region of Enrollment United States | 8 Participants | 6 Participants | 20 Participants | 6 Participants |
| Sex: Female, Male Female | 3 Participants | 0 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 16 Participants | 5 Participants |
| Stroke Impact Scale | 34.38 units on a scale STANDARD_DEVIATION 28.72 | 31.67 units on a scale STANDARD_DEVIATION 35.73 | 38.50 units on a scale STANDARD_DEVIATION 31.29 | 50.83 units on a scale STANDARD_DEVIATION 32 |
| Wolf Motor Function Test | 49.75 units on a scale STANDARD_DEVIATION 20.25 | 45.17 units on a scale STANDARD_DEVIATION 17.38 | 51.40 units on a scale STANDARD_DEVIATION 16.97 | 59.83 units on a scale STANDARD_DEVIATION 9.06 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 1 / 8 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 8 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 1 / 8 | 0 / 6 |
Outcome results
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.
Time frame: Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Repetitive Task Practice (RTP) | Wolf Motor Function Test (WMFT) | EOT | 49.80 units on a scale | Standard Deviation 18.94 |
| Repetitive Task Practice (RTP) | Wolf Motor Function Test (WMFT) | Baseline | 45.17 units on a scale | Standard Deviation 17.38 |
| Repetitive Task Practice (RTP) | Wolf Motor Function Test (WMFT) | EOT+4 | 50.80 units on a scale | Standard Deviation 21.35 |
| Voluntary Cycling + RTP | Wolf Motor Function Test (WMFT) | EOT | 48.83 units on a scale | Standard Deviation 18.1 |
| Voluntary Cycling + RTP | Wolf Motor Function Test (WMFT) | Baseline | 49.75 units on a scale | Standard Deviation 20.25 |
| Voluntary Cycling + RTP | Wolf Motor Function Test (WMFT) | EOT+4 | 50.33 units on a scale | Standard Deviation 19.35 |
| Assisted Cycling + RTP | Wolf Motor Function Test (WMFT) | Baseline | 59.83 units on a scale | Standard Deviation 9.06 |
| Assisted Cycling + RTP | Wolf Motor Function Test (WMFT) | EOT+4 | 69.50 units on a scale | Standard Deviation 5.61 |
| Assisted Cycling + RTP | Wolf Motor Function Test (WMFT) | EOT | 68.67 units on a scale | Standard Deviation 6.31 |
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.
Time frame: Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Repetitive Task Practice (RTP) | The Fugl-Meyer Assessment (FMA) | EOT | 29.80 units on a scale | Standard Deviation 11.97 |
| Repetitive Task Practice (RTP) | The Fugl-Meyer Assessment (FMA) | Baseline | 26.83 units on a scale | Standard Deviation 7.83 |
| Repetitive Task Practice (RTP) | The Fugl-Meyer Assessment (FMA) | EOT+4 | 33.40 units on a scale | Standard Deviation 15.04 |
| Voluntary Cycling + RTP | The Fugl-Meyer Assessment (FMA) | EOT | 35.33 units on a scale | Standard Deviation 14.65 |
| Voluntary Cycling + RTP | The Fugl-Meyer Assessment (FMA) | Baseline | 34.75 units on a scale | Standard Deviation 13.58 |
| Voluntary Cycling + RTP | The Fugl-Meyer Assessment (FMA) | EOT+4 | 37.00 units on a scale | Standard Deviation 17.56 |
| Assisted Cycling + RTP | The Fugl-Meyer Assessment (FMA) | Baseline | 36.17 units on a scale | Standard Deviation 7.41 |
| Assisted Cycling + RTP | The Fugl-Meyer Assessment (FMA) | EOT+4 | 51.17 units on a scale | Standard Deviation 3.06 |
| Assisted Cycling + RTP | The Fugl-Meyer Assessment (FMA) | EOT | 48.50 units on a scale | Standard Deviation 6.75 |
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.
Time frame: Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Repetitive Task Practice (RTP) | The Stroke Impact Scale (SIS) | EOT | 35.00 units on a scale | Standard Deviation 26.93 |
| Repetitive Task Practice (RTP) | The Stroke Impact Scale (SIS) | Baseline | 31.67 units on a scale | Standard Deviation 35.73 |
| Repetitive Task Practice (RTP) | The Stroke Impact Scale (SIS) | EOT+4 | 34.00 units on a scale | Standard Deviation 22.75 |
| Voluntary Cycling + RTP | The Stroke Impact Scale (SIS) | EOT | 45.00 units on a scale | Standard Deviation 41.95 |
| Voluntary Cycling + RTP | The Stroke Impact Scale (SIS) | Baseline | 34.38 units on a scale | Standard Deviation 28.72 |
| Voluntary Cycling + RTP | The Stroke Impact Scale (SIS) | EOT+4 | 51.67 units on a scale | Standard Deviation 37.24 |
| Assisted Cycling + RTP | The Stroke Impact Scale (SIS) | Baseline | 50.83 units on a scale | Standard Deviation 32 |
| Assisted Cycling + RTP | The Stroke Impact Scale (SIS) | EOT+4 | 66.67 units on a scale | Standard Deviation 22.73 |
| Assisted Cycling + RTP | The Stroke Impact Scale (SIS) | EOT | 68.33 units on a scale | Standard Deviation 15.38 |