Cost-effectiveness and Efficacy of a Combined Intervention to Facilitate Motor Recovery Following Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Action Research Arm Test (ARAT)
Study Overview
Brief Summary
The purpose of this study is to investigate whether aerobic exercise improves the participant's ability to recover function in the arm and leg affected by the participant's stroke. The investigators are also calculating the cost effectiveness of the rehabilitation interventions.
Detailed Description
The aims of the study are to determine the clinical efficacy and cost-effectiveness of combining aerobic exercise training with upper extremity motor task practice to improve motor recovery following stroke. It is hypothesized that the neurophysiologic impact of aerobic exercise may augment motor recovery associated with motor task practice. To test this hypothesize, 60 individuals with chronic stroke will be recruited to participate in this randomized clinical trial. Following screening and informed consent, all participants will undergo an exercise stress test to determine response to maximal exertion. Following the stress test, baseline clinical assessments will be obtained to quantify upper extremity function, gait, endurance, and self-reported quality of life. Additionally, variables to determine degree of disability will be obtained. Individuals will be randomized to one of two interventions: 45 min of forced-rate aerobic exercise paired with 45 min of upper limb repetitive task practice or two back-to-back 45-minute sessions of upper limb repetitive task practice. The interventions will occur 3 times per week for 8 weeks. Outcomes assessing motor function and disability will be repeated at mid-treatment, end of treatment, and at 4 weeks, 6-months and 12-months following end of treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Aerobic Exercise & Repetitive Task Practice
Participants will perform the following:
- 45 minutes of cycling
- 45 minutes of upper extremity repetitive arm exercises
Intervention: Aerobic Exercise (Behavioral)
Aerobic Exercise & Repetitive Task Practice
Participants will perform the following:
- 45 minutes of cycling
- 45 minutes of upper extremity repetitive arm exercises
Intervention: Upper Extremity Repetitive Task Practice (Behavioral)
Upper Extremity Repetitive Task Practice Only
Participants will perform the following:
1. 90 minutes of upper extremity repetitive arm exercises
Intervention: Upper Extremity Repetitive Task Practice (Behavioral)
Outcomes
Primary Outcomes
Action Research Arm Test (ARAT)
Time Frame: end of treatment +1 year (14 months from Baseline)
The Action Research Arm Test 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. The test includes 4 subscales: grasp (6 items, score range 0-18), grip (4 items, score range 0-12), pinch (6 items, score range 0-18), and gross motor (3 items, score range 0-9 ) which are added up for the total score. For all subscales, higher scores indicate better function.
Fugl-Meyer Assessment (FMA)
Time Frame: end of treatment +1 year (14 months from Baseline)
The Fugl-Meyer Assessment 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.
Action Research Arm Test (ARAT)
Time Frame: end of treatment +1 year (14 months from Baseline)
The Action Research Arm Test 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. The test includes 4 subscales: grasp (6 items, score range 0-18), grip (4 items, score range 0-12), pinch (6 items, score range 0-18), and gross motor (3 items, score range 0-9 ) which are added up for the total score. For all subscales, higher scores indicate better function.
Fugl-Meyer Assessment (FMA)
Time Frame: Baseline
The Fugl-Meyer Assessment 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.
Fugl-Meyer Assessment (FMA)
Time Frame: midpoint (4 weeks from Baseline)
The Fugl-Meyer Assessment 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.
Fugl-Meyer Assessment (FMA)
Time Frame: end of treatment (8 weeks from Baseline)
The Fugl-Meyer Assessment 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.
Fugl-Meyer Assessment (FMA)
Time Frame: end of treatment +4 weeks (12 weeks from Baseline)
The Fugl-Meyer Assessment 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.
Fugl-Meyer Assessment (FMA)
Time Frame: end of treatment +6 months (8 months from Baseline)
The Fugl-Meyer Assessment 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.
Action Research Arm Test (ARAT)
Time Frame: Baseline
The Action Research Arm Test 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. The test includes 4 subscales: grasp (6 items, score range 0-18), grip (4 items, score range 0-12), pinch (6 items, score range 0-18), and gross motor (3 items, score range 0-9 ) which are added up for the total score. For all subscales, higher scores indicate better function.
Action Research Arm Test (ARAT)
Time Frame: end of treatment (8 weeks from Baseline)
The Action Research Arm Test 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. The test includes 4 subscales: grasp (6 items, score range 0-18), grip (4 items, score range 0-12), pinch (6 items, score range 0-18), and gross motor (3 items, score range 0-9 ) which are added up for the total score. For all subscales, higher scores indicate better function.
Action Research Arm Test (ARAT)
Time Frame: end of treatment +4 weeks (12 weeks from Baseline)
The Action Research Arm Test 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.
Action Research Arm Test (ARAT)
Time Frame: end of treatment +6 months (8 months from Baseline)
The Action Research Arm Test 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. The test includes 4 subscales: grasp (6 items, score range 0-18), grip (4 items, score range 0-12), pinch (6 items, score range 0-18), and gross motor (3 items, score range 0-9 ) which are added up for the total score. For all subscales, higher scores indicate better function.
Secondary Outcomes
- Patient-Reported Outcomes Measurement Information System (PROMIS-29)(end of treatment +1 year (14 months from Baseline))
- Center for Epidemiological Studies-Depression (CES-D)(end of treatment +1 year (14 months from Baseline))
- Six-Minute Walk Test (6MWT)(end of treatment +1 year (14 months from Baseline))
- Paretic Step Length(end of treatment (8 weeks from Baseline))
- Wolf Motor Function Test (WMFT)(end of treatment (8 weeks from baseline))
- Stroke Impact Scale (SIS)(end of treatment +1 year (14 months from Baseline))
- Patient-Reported Outcomes Measurement Information System (PROMIS-29)(end of treatment +1 year (14 months from Baseline))
- Center for Epidemiological Studies-Depression (CES-D)(end of treatment +1 year (14 months from Baseline))
- Non-Paretic Step Length(end of treatment (8 weeks from Baseline))
- Non-Paretic Single Limb Percentage(end of treatment (8 weeks from Baseline))
- Modified Rankin Scale(end of treatment (8 weeks from Baseline))
- Walking Cadence(end of treatment (8 weeks from Baseline))
- Paretic Single Limb Percentage(end of treatment (8 weeks from Baseline))
- Paretic Knee Range of Motion(end of treatment (8 weeks from Baseline))
- Non-Paretic Knee Range of Motion(end of treatment (8 weeks from Baseline))
- Paretic Ankle Range of Motion(end of treatment (8 weeks from Baseline))
- Non-Paretic Ankle Range of Motion(end of treatment (8 weeks from Baseline))
- Paretic Hip Range of Motion (Sagittal Plane)(end of treatment (8 weeks from Baseline))
- Non-Paretic Hip Range of Motion (Sagittal Plane)(end of treatment (8 weeks from Baseline))
- Wolf Motor Function Test (WMFT) Functional Ability Score(Baseline)
- Wolf Motor Function Test (WMFT) Grip Strength(baseline)
- Wolf Motor Function Test (WMFT) Weight to Box(baseline)
- Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity(end of treatment + 12 months (14 months from baseline))
- Non-Paretic Step Length(Baseline)
- Patient-Reported Outcomes Measurement Information System (PROMIS-29)(end of treatment +6 months (8 months from Baseline))
- Paretic Step Length(Baseline)
- Wolf Motor Function Test (WMFT)(Baseline)
- Stroke Impact Scale (SIS)(Baseline)
- Center for Epidemiological Studies-Depression (CES-D)(Baseline)
- Stroke Impact Scale (SIS)(end of treatment (8 weeks from Baseline))
- Stroke Impact Scale (SIS)(end of treatment +6 months (8 months from Baseline))
- Patient-Reported Outcomes Measurement Information System (PROMIS-29)(Baseline)
- Patient-Reported Outcomes Measurement Information System (PROMIS-29)(end of treatment (8 weeks from Baseline))
- Six-Minute Walk Test (6MWT)(end of treatment +6 months (8 months from Baseline))
- Center for Epidemiological Studies-Depression (CES-D)(end of treatment (8 weeks from Baseline))
- Center for Epidemiological Studies-Depression (CES-D)(end of treatment +6 months (8 months from Baseline))
- Six-Minute Walk Test (6MWT)(Baseline)
- Six-Minute Walk Test (6MWT)(end of treatment (8 weeks))
- Six-Minute Walk Test (6MWT)(end of treatment +4 weeks (12 weeks from Baseline))
- Non-Paretic Single Limb Percentage(Baseline)
- Modified Rankin Scale(Baseline)
- Walking Cadence(Baseline)
- Paretic Single Limb Percentage(Baseline)
- Paretic Knee Range of Motion(Baseline)
- Non-Paretic Knee Range of Motion(Baseline)
- Paretic Ankle Range of Motion(Baseline)
- Non-Paretic Ankle Range of Motion(Baseline)
- Paretic Hip Range of Motion (Sagittal Plane)(Baseline)
- Non-Paretic Hip Range of Motion (Sagittal Plane)(Baseline)
- Wolf Motor Function Test (WMFT) Functional Ability Score(End of Treatment (8 weeks from baseline))
- Wolf Motor Function Test (WMFT) Grip Strength(End of Treatment (8 weeks from baseline))
- Wolf Motor Function Test (WMFT) Weight to Box(End of Treatment (8 weeks from baseline))
- Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity(End of Treatment (8 weeks following baseline))
- Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity(Baseline)
- Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity(end of treatment + 6 months (8 months from baseline))
Investigators
Susan Linder
Project Scientist, Principle Investigator
The Cleveland Clinic