- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03819764
Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation
Cost-effectiveness and Efficacy of a Combined Intervention to Facilitate Motor Recovery Following Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Main Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥ 6 months following single ischemic or hemorrhagic stroke confirmed with neuroimaging,
- Fugl-Meyer motor score 19-55 in the involved upper extremity,
- Ambulatory ≥ 20 meters with no more than contact guard assistance, and
- 18-85 years of age.
Exclusion Criteria:
- hospitalization for myocardial infarction, heart failure or heart surgery within 3 months,
- cardiac arrhythmia,
- hypertrophic cardiomyopathy,
- severe aortic stenosis,
- pulmonary embolus,
- significant contractures,
- anti-spasticity injection within 3 months of enrollment and
- other contraindication to exercise
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aerobic Exercise & Repetitive Task Practice
Participants will perform the following:
|
Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
Repetitive arm exercises
|
Active Comparator: Upper Extremity Repetitive Task Practice Only
Participants will perform the following: 1. 90 minutes of upper extremity repetitive arm exercises |
Repetitive arm exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fugl-Meyer Assessment (FMA)
Time Frame: Baseline
|
This is a 33 item assessment of post-stroke upper extremity impairment.
Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
|
Baseline
|
Fugl-Meyer Assessment (FMA)
Time Frame: midpoint (4 weeks from Baseline)
|
This is a 33 item assessment of post-stroke upper extremity impairment.
Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
|
midpoint (4 weeks from Baseline)
|
Fugl-Meyer Assessment (FMA)
Time Frame: end of treatment (8 weeks from Baseline)
|
This is a 33 item assessment of post-stroke upper extremity impairment.
Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
|
end of treatment (8 weeks from Baseline)
|
Fugl-Meyer Assessment (FMA)
Time Frame: end of treatment +4 weeks (12 weeks from Baseline)
|
This is a 33 item assessment of post-stroke upper extremity impairment.
Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
|
end of treatment +4 weeks (12 weeks from Baseline)
|
Fugl-Meyer Assessment (FMA)
Time Frame: end of treatment +6 months (8 months from Baseline)
|
This is a 33 item assessment of post-stroke upper extremity impairment.
Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
|
end of treatment +6 months (8 months from Baseline)
|
Fugl-Meyer Assessment (FMA)
Time Frame: end of treatment +1 year (14 months from Baseline)
|
This is a 33 item assessment of post-stroke upper extremity impairment.
Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
|
end of treatment +1 year (14 months from Baseline)
|
Action Research Arm Test (ARAT)
Time Frame: Baseline
|
This is an assessment of post-stroke upper extremity function.
Total score is reported, scores range from 0-57, with higher scores indicating a better outcome.
|
Baseline
|
Action Research Arm Test (ARAT)
Time Frame: end of treatment (8 weeks from Baseline)
|
This is an assessment of post-stroke upper extremity function.
Total score is reported, scores range from 0-57, with higher scores indicating a better outcome.
|
end of treatment (8 weeks from Baseline)
|
Action Research Arm Test (ARAT)
Time Frame: end of treatment +4 weeks (12 weeks from Baseline)
|
This is an assessment of post-stroke upper extremity function.
Total score is reported, scores range from 0-57, with higher scores indicating a better outcome.
|
end of treatment +4 weeks (12 weeks from Baseline)
|
Action Research Arm Test (ARAT)
Time Frame: end of treatment +6 months (8 months from Baseline)
|
This is an assessment of post-stroke upper extremity function.
Total score is reported, scores range from 0-57, with higher scores indicating a better outcome.
|
end of treatment +6 months (8 months from Baseline)
|
Action Research Arm Test (ARAT)
Time Frame: end of treatment +1 year (14 months from Baseline)
|
This is an assessment of post-stroke upper extremity function.
Total score is reported, scores range from 0-57, with higher scores indicating a better outcome.
|
end of treatment +1 year (14 months from Baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wolf Motor Function Test (WMFT)
Time Frame: Baseline
|
This consists of 2 strength tasks and 15 timed tasks of both the affected upper extremity and the unaffected upper extremity.
Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome.
|
Baseline
|
Wolf Motor Function Test (WMFT)
Time Frame: end of treatment (8 weeks from Baseline)
|
This consists of 2 strength tasks and 15 timed tasks of both the affected upper extremity and the unaffected upper extremity.
Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome.
|
end of treatment (8 weeks from Baseline)
|
Stroke Impact Scale (SIS)
Time Frame: Baseline
|
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
|
Stroke Impact Scale (SIS)
Time Frame: end of treatment (8 weeks from Baseline)
|
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.
|
end of treatment (8 weeks from Baseline)
|
Stroke Impact Scale (SIS)
Time Frame: end of treatment +6 months (8 months from Baseline)
|
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.
|
end of treatment +6 months (8 months from Baseline)
|
Stroke Impact Scale (SIS)
Time Frame: end of treatment +1 year (14 months from Baseline)
|
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.
|
end of treatment +1 year (14 months from Baseline)
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time Frame: Baseline
|
A self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference.
|
Baseline
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time Frame: end of treatment (8 weeks from Baseline)
|
A self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference.
|
end of treatment (8 weeks from Baseline)
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time Frame: end of treatment +6 months (8 months from Baseline)
|
A self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference.
|
end of treatment +6 months (8 months from Baseline)
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time Frame: end of treatment +1 year (14 months from Baseline)
|
A self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference.
|
end of treatment +1 year (14 months from Baseline)
|
Center for Epidemiological Studies-Depression (CES-D)
Time Frame: Baseline
|
This is a 20 item assessment of depressive symptomology.
Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression.
|
Baseline
|
Center for Epidemiological Studies-Depression (CES-D)
Time Frame: end of treatment (8 weeks from Baseline)
|
This is a 20 item assessment of depressive symptomology.
Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression.
|
end of treatment (8 weeks from Baseline)
|
Center for Epidemiological Studies-Depression (CES-D)
Time Frame: end of treatment +6 months (8 months from Baseline)
|
This is a 20 item assessment of depressive symptomology.
Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression.
|
end of treatment +6 months (8 months from Baseline)
|
Center for Epidemiological Studies-Depression (CES-D)
Time Frame: end of treatment +1 year (14 months from Baseline)
|
This is a 20 item assessment of depressive symptomology.
Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression.
|
end of treatment +1 year (14 months from Baseline)
|
Six-Minute Walk Test (6MWT)
Time Frame: Baseline
|
Total distance (feet) traveled over a 6 minute period.
|
Baseline
|
Six-Minute Walk Test (6MWT)
Time Frame: end of treatment (8 weeks)
|
Total distance (feet) traveled over a 6 minute period.
|
end of treatment (8 weeks)
|
Six-Minute Walk Test (6MWT)
Time Frame: end of treatment +4 weeks (12 weeks from Baseline)
|
Total distance (feet) traveled over a 6 minute period.
|
end of treatment +4 weeks (12 weeks from Baseline)
|
Six-Minute Walk Test (6MWT)
Time Frame: end of treatment +6 months (8 months from Baseline)
|
Total distance (feet) traveled over a 6 minute period.
|
end of treatment +6 months (8 months from Baseline)
|
Six-Minute Walk Test (6MWT)
Time Frame: end of treatment +1 year (14 months from Baseline)
|
Total distance (feet) traveled over a 6 minute period.
|
end of treatment +1 year (14 months from Baseline)
|
Modified Rankin Scale
Time Frame: Baseline
|
0-6 scale to determine degree of disability in individuals with a disabling condition.
A score of 0 indicates no symptoms, 1 indicates no significant disability despite symptoms, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe level of disability, 5 indicates severe disability, and 6 indicates death.
|
Baseline
|
Modified Rankin Scale
Time Frame: end of treatment (8 weeks from Baseline)
|
0-6 scale to determine degree of disability in individuals with a disabling condition.
A score of 0 indicates no symptoms, 1 indicates no significant disability despite symptoms, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe level of disability, 5 indicates severe disability, and 6 indicates death.
|
end of treatment (8 weeks from Baseline)
|
Modified Rankin Scale
Time Frame: end of treatment +6 months (8 months from Baseline)
|
0-6 scale to determine degree of disability in individuals with a disabling condition.
A score of 0 indicates no symptoms, 1 indicates no significant disability despite symptoms, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe level of disability, 5 indicates severe disability, and 6 indicates death.
|
end of treatment +6 months (8 months from Baseline)
|
Modified Rankin Scale
Time Frame: end of treatment +1 year (14 months from Baseline)
|
0-6 scale to determine degree of disability in individuals with a disabling condition.
A score of 0 indicates no symptoms, 1 indicates no significant disability despite symptoms, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe level of disability, 5 indicates severe disability, and 6 indicates death.
|
end of treatment +1 year (14 months from Baseline)
|
Right Step Length
Time Frame: Baseline
|
Mean right step length (cm) across two 2-minute walking trials
|
Baseline
|
Right Step Length
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean right step length (cm) across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Left Step Length
Time Frame: Baseline
|
Mean left step length (cm) across two 2-minute walking trials
|
Baseline
|
Left Step Length
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean left step length (cm) across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Right Step Width
Time Frame: Baseline
|
Mean right step width (cm) across two 2-minute walking trials
|
Baseline
|
Right Step Width
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean right step width (cm) across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Left Step Width
Time Frame: Baseline
|
Mean left step width (cm) across two 2-minute walking trials
|
Baseline
|
Left Step Width
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean left step width (cm) across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Right Stance Time
Time Frame: Baseline
|
Mean time (in seconds) spent in stance phase on the right lower extremity across two 2-minute walking trials
|
Baseline
|
Right Stance Time
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean time (in seconds) spent in stance phase on the right lower extremity across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Left Stance Time
Time Frame: Baseline
|
Mean time (in seconds) spent in stance phase on the left lower extremity across two 2-minute walking trials
|
Baseline
|
Left Stance Time
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean time (in seconds) spent in stance phase on the left lower extremity across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Right Swing Time
Time Frame: Baseline
|
Mean time (in seconds) spent in swing phase on the right lower extremity across two 2-minute walking trials
|
Baseline
|
Right Swing Time
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean time (in seconds) spent in swing phase on the right lower extremity across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Left Swing Time
Time Frame: Baseline
|
Mean time (in seconds) spent in swing phase on the left lower extremity across two 2-minute walking trials
|
Baseline
|
Left Swing Time
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean time (in seconds) spent in swing phase on the left lower extremity across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Walking Speed
Time Frame: Baseline
|
Mean m/s across two 2-minute walking trials
|
Baseline
|
Walking Speed
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean m/s across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Walking Cadence
Time Frame: Baseline
|
Mean steps/minute across two 2-minute walking trials
|
Baseline
|
Walking Cadence
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean steps/minute across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Left Knee Range of Motion
Time Frame: Baseline
|
Mean peak degree of left knee flexion across two 2-minute walking trials
|
Baseline
|
Left Knee Range of Motion
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean peak degree of left knee flexion across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Right Knee Range of Motion
Time Frame: Baseline
|
Mean peak degree of right knee flexion across two 2-minute walking trials
|
Baseline
|
Right Knee Range of Motion
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean peak degree of right knee flexion across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Left Ankle Range of Motion
Time Frame: Baseline
|
Mean peak degree of left ankle dorsiflexion across two 2-minute walking trials
|
Baseline
|
Left Ankle Range of Motion
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean peak degree of left ankle dorsiflexion across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Right Ankle Range of Motion
Time Frame: Baseline
|
Mean peak degree of right ankle dorsiflexion across two 2-minute walking trials
|
Baseline
|
Right Ankle Range of Motion
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean peak degree of right ankle dorsiflexion across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Left Hip Range of Motion (sagittal plane)
Time Frame: Baseline
|
Mean peak degree of left hip flexion across two 2-minute walking trials
|
Baseline
|
Left Hip Range of Motion (sagittal plane)
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean peak degree of left hip flexion across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Right Hip Range of Motion (sagittal plane)
Time Frame: Baseline
|
Mean peak degree of right hip flexion across two 2-minute walking trials
|
Baseline
|
Right Hip Range of Motion (sagittal plane)
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean peak degree of right hip flexion across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Left Hip Range of Motion (coronal plane)
Time Frame: Baseline
|
Mean peak degree of left hip abduction across two 2-minute walking trials
|
Baseline
|
Left Hip Range of Motion (coronal plane)
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean peak degree of left hip abduction across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Right Hip Range of Motion (coronal plane)
Time Frame: Baseline
|
Mean peak degree of right hip abduction across two 2-minute walking trials
|
Baseline
|
Right Hip Range of Motion (coronal plane)
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean peak degree of right hip abduction across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Left Hip Range of Motion (transverse plane)
Time Frame: Baseline
|
Mean peak degree of left hip external rotation across two 2-minute walking trials
|
Baseline
|
Left Hip Range of Motion (transverse plane)
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean peak degree of left hip external rotation across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Right Hip Range of Motion (transverse plane)
Time Frame: Baseline
|
Mean peak degree of right hip external rotation across two 2-minute walking trials
|
Baseline
|
Right Hip Range of Motion (transverse plane)
Time Frame: end of treatment (8 weeks from Baseline)
|
Mean peak degree of right hip external rotation across two 2-minute walking trials
|
end of treatment (8 weeks from Baseline)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susan Linder, DPT, The Cleveland Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-734
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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