Brain Diseases, Cardiovascular Diseases, Central Nervous System Diseases, Cerebrovascular Disorders, Nervous System Diseases, Stroke, Vascular Diseases
Conditions
Keywords
stroke, aerobic exercise, forced exercise, repetitive task practice, arm function, upper extremity
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.
Interventions
BEHAVIORALAerobic Exercise
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
BEHAVIORALUpper Extremity Repetitive Task Practice
Repetitive arm exercises
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
1. ≥ 6 months following single ischemic or hemorrhagic stroke confirmed with neuroimaging, 2. Fugl-Meyer motor score 19-55 in the involved upper extremity, 3. Ambulatory ≥ 20 meters with no more than contact guard assistance, and 4. 18-85 years of age.
Exclusion criteria
1. hospitalization for myocardial infarction, heart failure or heart surgery within 3 months, 2. cardiac arrhythmia, 3. hypertrophic cardiomyopathy, 4. severe aortic stenosis, 5. pulmonary embolus, 6. significant contractures, 7. anti-spasticity injection within 3 months of enrollment and 8. other contraindication to exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment (FMA) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Baseline | The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is 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. * A score of 50 represents the population mean. * A score of 40 is one standard deviation lower than the mean of the reference population. * A score of 60 is one standard deviation higher than the mean of the reference population. * For PROMIS measures, higher scores for domains measuring symptoms is indicative of greater symptom burden. Therefore, higher scores are worse for fatigue, anxiety, depression, sleep disturbance, and pain interference. For the domains of Physical Function and Participation, higher scores indicate better function and better participation, respectively. |
| Center for Epidemiological Studies-Depression (CES-D) | Baseline | The Center for Epidemiological Studies-Depression (CES-D) 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. A score of 16 or more is indicative of depression. |
| Six-Minute Walk Test (6MWT) | Baseline | The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period. |
| Paretic Step Length | Baseline | Mean Paretic step length (cm) across two 2-minute walking trials |
| Non-Paretic Step Length | Baseline | Mean Non-Paretic step length (cm) across two 2-minute walking trials |
| Non-Paretic Single Limb Percentage | Baseline | Percentage of gait cycle spent in single limb support |
| Modified Rankin Scale | Baseline | The modified Rankin Scale is a global outcome on a scale of 0-6 used to assess the degree of disability in patients with stroke as follows: 0 No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead |
| Walking Cadence | Baseline | Steps walked per minute during two 2-minute walking trials |
| Paretic Single Limb Percentage | Baseline | Percentage of gait cycle spent in single limb support |
| Wolf Motor Function Test (WMFT) | Baseline | The Wolf Motor Function Test includes 15 timed tasks for the affected upper extremity. Times for timed tasks are transformed and reported as geometric mean (standard deviation). Lower times indicate better performance. |
| Non-Paretic Knee Range of Motion | Baseline | Mean peak degree of non-paretic knee flexion across two 2-minute walking trials |
| Paretic Ankle Range of Motion | Baseline | Mean peak degree of paretic ankle dorsiflexion across two 2-minute walking trials |
| Non-Paretic Ankle Range of Motion | Baseline | Non-Paretic peak degree of non-paretic dorsiflexion across two 2-minute walking trials |
| Paretic Hip Range of Motion (Sagittal Plane) | Baseline | Mean peak degree of paretic hip flexion across two 2-minute walking trials |
| Non-Paretic Hip Range of Motion (Sagittal Plane) | Baseline | Mean peak degree of non-paretic hip flexion across two 2-minute walking trials |
| Wolf Motor Function Test (WMFT) Functional Ability Score | End of Treatment (8 weeks from baseline) | The Wolf Motor Function Test Functional Ability Score quantifies movement quality. Scores range from 0-75, with higher scores indicating a better outcome. |
| Wolf Motor Function Test (WMFT) Grip Strength | End of Treatment (8 weeks from baseline) | The Wolf Motor Function Test includes Grip strength measured by dynamometer |
| Wolf Motor Function Test (WMFT) Weight to Box | End of Treatment (8 weeks from baseline) | The Wolf Motor Function Test includes the amount of weight the individual can lift onto a box using a wrist cuff weight ranging from 1-20 pounds. Higher indicates greater strength. |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity | End of Treatment (8 weeks following baseline) | The Patient-Reported Outcomes Measurement Information System includes pain rated on a 0-10 scale with higher scores indicative of greater pain. |
| Paretic Knee Range of Motion | Baseline | Mean peak degree of paretic knee flexion across two 2-minute walking trials |
| Stroke Impact Scale (SIS) | Baseline | The Stroke Impact Scale is a self-reported questionnaire evaluating quality of life. 8 domains are assessed including: physical problems, memory and thinking, feelings, communication, activities of daily living (ADLs), mobility, hand use, and meaningful activities. Scores for all domains are normalized and range from 0-100, with higher scores indicating a better self-perceived quality of life. The last domain (stroke recovery) asks the individual to rate their recovery on a scale of 0-100, with 0 indicating no recovery and 100 indicating full recovery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aerobic Exercise & Repetitive Task Practice Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: 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
Upper Extremity Repetitive Task Practice: Repetitive arm exercises | 30 |
| Upper Extremity Repetitive Task Practice Only Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Upper Extremity Repetitive Task Practice Only | Total | Aerobic Exercise & Repetitive Task Practice |
|---|---|---|---|
| Age, Continuous | 60.2 years STANDARD_DEVIATION 9.8 | 60.5 years STANDARD_DEVIATION 10.6 | 60.8 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 60 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 47 Participants | 23 Participants |
| Sex: Female, Male Female | 17 Participants | 29 Participants | 12 Participants |
| Sex: Female, Male Male | 13 Participants | 31 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 1 / 30 |
| other Total, other adverse events | 5 / 30 | 8 / 30 |
| serious Total, serious adverse events | 2 / 30 | 2 / 30 |
Outcome results
Primary
Action Research Arm Test (ARAT)
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.
Time frame: end of treatment +1 year (14 months from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Grasp | 14.2 score on a scale | Standard Deviation 6 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Pinch | 10.0 score on a scale | Standard Deviation 7.5 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Grip | 7.1 score on a scale | Standard Deviation 4 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Gross | 7.3 score on a scale | Standard Deviation 2.5 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Total | 38.5 score on a scale | Standard Deviation 18.4 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Gross | 8.0 score on a scale | Standard Deviation 1.6 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Total | 40.9 score on a scale | Standard Deviation 17.6 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Grasp | 14.1 score on a scale | Standard Deviation 6.3 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Grip | 8.0 score on a scale | Standard Deviation 4.1 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Pinch | 10.7 score on a scale | Standard Deviation 7.2 |
Primary
Action Research Arm Test (ARAT)
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.
Time frame: end of treatment +4 weeks (12 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Grasp | 13.7 score on a scale | Standard Deviation 6 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Pinch | 10.4 score on a scale | Standard Deviation 7.1 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Grip | 7.8 score on a scale | Standard Deviation 4.1 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Gross | 7.4 score on a scale | Standard Deviation 2.4 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Total | 39.3 score on a scale | Standard Deviation 18.2 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Gross | 7.2 score on a scale | Standard Deviation 2.41 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Total | 36.2 score on a scale | Standard Deviation 19.8 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Grasp | 12.6 score on a scale | Standard Deviation 6.8 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Grip | 7.0 score on a scale | Standard Deviation 4.4 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Pinch | 9.4 score on a scale | Standard Deviation 7.3 |
Primary
Action Research Arm Test (ARAT)
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.
Time frame: end of treatment +6 months (8 months from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Grasp | 13.2 score on a scale | Standard Deviation 6.4 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Pinch | 9.1 score on a scale | Standard Deviation 7.8 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Grip | 7.5 score on a scale | Standard Deviation 4.2 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Gross | 7.2 score on a scale | Standard Deviation 2.5 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Total | 37.1 score on a scale | Standard Deviation 19.4 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Gross | 8.0 score on a scale | Standard Deviation 1.7 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Total | 39.1 score on a scale | Standard Deviation 18.3 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Grasp | 13.6 score on a scale | Standard Deviation 6.6 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Grip | 7.4 score on a scale | Standard Deviation 4.2 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Pinch | 10.2 score on a scale | Standard Deviation 7.2 |
Primary
Action Research Arm Test (ARAT)
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.
Time frame: end of treatment (8 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Grasp | 13.0 score on a scale | Standard Deviation 6.2 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Pinch | 9.9 score on a scale | Standard Deviation 6.9 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Grip | 7.6 score on a scale | Standard Deviation 3.6 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Gross | 7.2 score on a scale | Standard Deviation 2.4 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Total | 37.7 score on a scale | Standard Deviation 17.9 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Gross | 7.3 score on a scale | Standard Deviation 2.1 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Total | 36.4 score on a scale | Standard Deviation 18.5 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Grasp | 12.6 score on a scale | Standard Deviation 6.6 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Grip | 7.1 score on a scale | Standard Deviation 4 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Pinch | 9.4 score on a scale | Standard Deviation 7.1 |
Primary
Action Research Arm Test (ARAT)
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.
Time frame: Baseline
Population: individuals with chronic stroke and residual upper limb paresis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Grasp | 11.2 score on a scale | Standard Deviation 5.7 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Pinch | 8.0 score on a scale | Standard Deviation 6.6 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Grip | 6.8 score on a scale | Standard Deviation 3.1 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Gross | 6.5 score on a scale | Standard Deviation 2.3 |
| Aerobic Exercise & Repetitive Task Practice | Action Research Arm Test (ARAT) | ARAT Total | 32.5 score on a scale | Standard Deviation 16.6 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Gross | 6.9 score on a scale | Standard Deviation 2.3 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Total | 32.8 score on a scale | Standard Deviation 18.6 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Grasp | 11.4 score on a scale | Standard Deviation 6.8 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Grip | 6.0 score on a scale | Standard Deviation 3.9 |
| Upper Extremity Repetitive Task Practice Only | Action Research Arm Test (ARAT) | ARAT Pinch | 8.5 score on a scale | Standard Deviation 7 |
Primary
Fugl-Meyer Assessment (FMA)
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.
Time frame: end of treatment +1 year (14 months from Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Fugl-Meyer Assessment (FMA) | 44.8 score on a scale | Standard Deviation 12.9 |
| Upper Extremity Repetitive Task Practice Only | Fugl-Meyer Assessment (FMA) | 46.8 score on a scale | Standard Deviation 13.6 |
Primary
Fugl-Meyer Assessment (FMA)
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.
Time frame: end of treatment +6 months (8 months from Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Fugl-Meyer Assessment (FMA) | 45.1 score on a scale | Standard Deviation 12.8 |
| Upper Extremity Repetitive Task Practice Only | Fugl-Meyer Assessment (FMA) | 43.7 score on a scale | Standard Deviation 14.3 |
Primary
Fugl-Meyer Assessment (FMA)
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Fugl-Meyer Assessment (FMA) | 32.5 score on a scale | Standard Deviation 16.6 |
| Upper Extremity Repetitive Task Practice Only | Fugl-Meyer Assessment (FMA) | 32.8 score on a scale | Standard Deviation 18.6 |
Primary
Fugl-Meyer Assessment (FMA)
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.
Time frame: midpoint (4 weeks from Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Fugl-Meyer Assessment (FMA) | 44.0 score on a scale | Standard Deviation 11.8 |
| Upper Extremity Repetitive Task Practice Only | Fugl-Meyer Assessment (FMA) | 41.2 score on a scale | Standard Deviation 13.4 |
Primary
Fugl-Meyer Assessment (FMA)
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.
Time frame: end of treatment (8 weeks from Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Fugl-Meyer Assessment (FMA) | 44.6 score on a scale | Standard Deviation 12.5 |
| Upper Extremity Repetitive Task Practice Only | Fugl-Meyer Assessment (FMA) | 42.1 score on a scale | Standard Deviation 13.5 |
Primary
Fugl-Meyer Assessment (FMA)
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.
Time frame: end of treatment +4 weeks (12 weeks from Baseline)
Population: individuals with chronic stroke and residual upper limb paresis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Fugl-Meyer Assessment (FMA) | 44.6 score on a scale | Standard Deviation 12.5 |
| Upper Extremity Repetitive Task Practice Only | Fugl-Meyer Assessment (FMA) | 42.1 score on a scale | Standard Deviation 13.5 |
Secondary
Center for Epidemiological Studies-Depression (CES-D)
The Center for Epidemiological Studies-Depression (CES-D) 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. A score of 16 or more is indicative of depression.
Time frame: end of treatment (8 weeks from Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Center for Epidemiological Studies-Depression (CES-D) | 9.9 units on a scale | Standard Deviation 9.3 |
| Upper Extremity Repetitive Task Practice Only | Center for Epidemiological Studies-Depression (CES-D) | 8.8 units on a scale | Standard Deviation 9.3 |
Secondary
Center for Epidemiological Studies-Depression (CES-D)
The Center for Epidemiological Studies-Depression (CES-D) 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. A score of 16 or more is indicative of depression.
Time frame: end of treatment +1 year (14 months from Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Center for Epidemiological Studies-Depression (CES-D) | 9.3 units on a scale | Standard Deviation 8.3 |
| Upper Extremity Repetitive Task Practice Only | Center for Epidemiological Studies-Depression (CES-D) | 9.7 units on a scale | Standard Deviation 9.7 |
Secondary
Center for Epidemiological Studies-Depression (CES-D)
The Center for Epidemiological Studies-Depression (CES-D) 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. A score of 16 or more is indicative of depression.
Time frame: end of treatment +6 months (8 months from Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Center for Epidemiological Studies-Depression (CES-D) | 9.3 units on a scale | Standard Deviation 7.8 |
| Upper Extremity Repetitive Task Practice Only | Center for Epidemiological Studies-Depression (CES-D) | 8.6 units on a scale | Standard Deviation 8.5 |
Secondary
Center for Epidemiological Studies-Depression (CES-D)
The Center for Epidemiological Studies-Depression (CES-D) 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. A score of 16 or more is indicative of depression.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Center for Epidemiological Studies-Depression (CES-D) | 11.3 units on a scale | Standard Deviation 8.5 |
| Upper Extremity Repetitive Task Practice Only | Center for Epidemiological Studies-Depression (CES-D) | 9.6 units on a scale | Standard Deviation 7.4 |
Secondary
Modified Rankin Scale
The modified Rankin Scale is a global outcome on a scale of 0-6 used to assess the degree of disability in patients with stroke as follows: 0 No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
Time frame: end of treatment (8 weeks from Baseline)
Population: individuals with chronic stroke and residual hemiparesis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Modified Rankin Scale | 2 score on a scale |
| Upper Extremity Repetitive Task Practice Only | Modified Rankin Scale | 2 score on a scale |
Secondary
Modified Rankin Scale
The modified Rankin Scale is a global outcome on a scale of 0-6 used to assess the degree of disability in patients with stroke as follows: 0 No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Modified Rankin Scale | 2 score on a scale |
| Upper Extremity Repetitive Task Practice Only | Modified Rankin Scale | 2 score on a scale |
Secondary
Non-Paretic Ankle Range of Motion
Non-Paretic peak degree of non-paretic dorsiflexion across two 2-minute walking trials
Time frame: Baseline
Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Non-Paretic Ankle Range of Motion | 23.3 Degrees | Standard Deviation 8.74 |
| Upper Extremity Repetitive Task Practice Only | Non-Paretic Ankle Range of Motion | 23.7 Degrees | Standard Deviation 7.28 |
Secondary
Non-Paretic Ankle Range of Motion
Mean peak degree of non-paretic ankle dorsiflexion across two 2-minute walking trials
Time frame: end of treatment (8 weeks from Baseline)
Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Non-Paretic Ankle Range of Motion | 24.8 Degrees | Standard Deviation 8.48 |
| Upper Extremity Repetitive Task Practice Only | Non-Paretic Ankle Range of Motion | 23.2 Degrees | Standard Deviation 6.89 |
Secondary
Non-Paretic Hip Range of Motion (Sagittal Plane)
Mean peak degree of non-paretic hip flexion across two 2-minute walking trials
Time frame: end of treatment (8 weeks from Baseline)
Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Non-Paretic Hip Range of Motion (Sagittal Plane) | 39.9 Degrees | Standard Deviation 9.37 |
| Upper Extremity Repetitive Task Practice Only | Non-Paretic Hip Range of Motion (Sagittal Plane) | 43.0 Degrees | Standard Deviation 5.89 |
Secondary
Non-Paretic Hip Range of Motion (Sagittal Plane)
Mean peak degree of non-paretic hip flexion across two 2-minute walking trials
Time frame: Baseline
Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Non-Paretic Hip Range of Motion (Sagittal Plane) | 36.9 Degrees | Standard Deviation 9.35 |
| Upper Extremity Repetitive Task Practice Only | Non-Paretic Hip Range of Motion (Sagittal Plane) | 41.3 Degrees | Standard Deviation 6.14 |
Secondary
Non-Paretic Knee Range of Motion
Mean peak degree of non-paretic knee flexion across two 2-minute walking trials
Time frame: end of treatment (8 weeks from Baseline)
Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Non-Paretic Knee Range of Motion | 54.8 Degrees | Standard Deviation 10.9 |
| Upper Extremity Repetitive Task Practice Only | Non-Paretic Knee Range of Motion | 62.4 Degrees | Standard Deviation 6.41 |
Secondary
Non-Paretic Knee Range of Motion
Mean peak degree of non-paretic knee flexion across two 2-minute walking trials
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Non-Paretic Knee Range of Motion | 53.6 Degrees | Standard Deviation 11.85 |
| Upper Extremity Repetitive Task Practice Only | Non-Paretic Knee Range of Motion | 60.5 Degrees | Standard Deviation 9.12 |
Secondary
Non-Paretic Single Limb Percentage
Mean percentage of gait cycle spent in stance phase on the Non-Paretic lower extremity across two 2-minute walking trials
Time frame: end of treatment (8 weeks from Baseline)
Population: individuals with chronic stroke and residual upper limb paresis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Non-Paretic Single Limb Percentage | 29.8 Percent | Standard Deviation 4.73 |
| Upper Extremity Repetitive Task Practice Only | Non-Paretic Single Limb Percentage | 30.5 Percent | Standard Deviation 2.3 |
Secondary
Non-Paretic Single Limb Percentage
Percentage of gait cycle spent in single limb support
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Non-Paretic Single Limb Percentage | 29.1 Percent | Standard Deviation 4.79 |
| Upper Extremity Repetitive Task Practice Only | Non-Paretic Single Limb Percentage | 30.1 Percent | Standard Deviation 2.64 |
Secondary
Non-Paretic Step Length
Mean Non-Paretic step length (cm) across two 2-minute walking trials
Time frame: end of treatment (8 weeks from Baseline)
Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Non-Paretic Step Length | 45.0 Centimeters | Standard Deviation 15.3 |
| Upper Extremity Repetitive Task Practice Only | Non-Paretic Step Length | 46.1 Centimeters | Standard Deviation 11.5 |
Secondary
Non-Paretic Step Length
Mean Non-Paretic step length (cm) across two 2-minute walking trials
Time frame: Baseline
Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Non-Paretic Step Length | 40.1 Centimeters | Standard Deviation 15.5 |
| Upper Extremity Repetitive Task Practice Only | Non-Paretic Step Length | 44.2 Centimeters | Standard Deviation 14.9 |
Secondary
Paretic Ankle Range of Motion
Mean peak degree of paretic ankle dorsiflexion across two 2-minute walking trials
Time frame: Baseline
Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Paretic Ankle Range of Motion | 17.8 Degrees | Standard Deviation 5.38 |
| Upper Extremity Repetitive Task Practice Only | Paretic Ankle Range of Motion | 19.5 Degrees | Standard Deviation 6.45 |
Secondary
Paretic Ankle Range of Motion
Mean peak degree of paretic ankle dorsiflexion across two 2-minute walking trials
Time frame: end of treatment (8 weeks from Baseline)
Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Paretic Ankle Range of Motion | 19.1 Degrees | Standard Deviation 5.46 |
| Upper Extremity Repetitive Task Practice Only | Paretic Ankle Range of Motion | 19.1 Degrees | Standard Deviation 6.1 |
Secondary
Paretic Hip Range of Motion (Sagittal Plane)
Mean peak degree of paretic hip flexion across two 2-minute walking trials
Time frame: end of treatment (8 weeks from Baseline)
Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Paretic Hip Range of Motion (Sagittal Plane) | 35.6 Degrees | Standard Deviation 10 |
| Upper Extremity Repetitive Task Practice Only | Paretic Hip Range of Motion (Sagittal Plane) | 39.5 Degrees | Standard Deviation 7.64 |
Secondary
Paretic Hip Range of Motion (Sagittal Plane)
Mean peak degree of paretic hip flexion across two 2-minute walking trials
Time frame: Baseline
Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Paretic Hip Range of Motion (Sagittal Plane) | 33.2 Degrees | Standard Deviation 9.39 |
| Upper Extremity Repetitive Task Practice Only | Paretic Hip Range of Motion (Sagittal Plane) | 37.4 Degrees | Standard Deviation 10.4 |
Secondary
Paretic Knee Range of Motion
Mean peak degree of paretic knee flexion across two 2-minute walking trials
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Paretic Knee Range of Motion | 43.0 Degrees | Standard Deviation 16.9 |
| Upper Extremity Repetitive Task Practice Only | Paretic Knee Range of Motion | 54.1 Degrees | Standard Deviation 14.4 |
Secondary
Paretic Knee Range of Motion
Mean peak degree of paretic knee flexion across two 2-minute walking trials
Time frame: end of treatment (8 weeks from Baseline)
Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Paretic Knee Range of Motion | 44.0 Degrees | Standard Deviation 17.5 |
| Upper Extremity Repetitive Task Practice Only | Paretic Knee Range of Motion | 53.4 Degrees | Standard Deviation 12.5 |
Secondary
Paretic Single Limb Percentage
Percentage of gait cycle spent in single limb support
Time frame: end of treatment (8 weeks from Baseline)
Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Paretic Single Limb Percentage | 27.9 Percent | Standard Deviation 3.4 |
| Upper Extremity Repetitive Task Practice Only | Paretic Single Limb Percentage | 28.9 Percent | Standard Deviation 2.7 |
Secondary
Paretic Single Limb Percentage
Percentage of gait cycle spent in single limb support
Time frame: Baseline
Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Paretic Single Limb Percentage | 26.8 Percentage | Standard Deviation 3.88 |
| Upper Extremity Repetitive Task Practice Only | Paretic Single Limb Percentage | 28.6 Percentage | Standard Deviation 2.76 |
Secondary
Paretic Step Length
Mean Paretic step length (cm) across two 2-minute walking trials
Time frame: end of treatment (8 weeks from Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Paretic Step Length | 45.0 Centimeters | Standard Deviation 12.6 |
| Upper Extremity Repetitive Task Practice Only | Paretic Step Length | 46.9 Centimeters | Standard Deviation 11.5 |
Secondary
Paretic Step Length
Mean Paretic step length (cm) across two 2-minute walking trials
Time frame: Baseline
Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Paretic Step Length | 40.4 Centimeters | Standard Deviation 14.1 |
| Upper Extremity Repetitive Task Practice Only | Paretic Step Length | 45.6 Centimeters | Standard Deviation 12.7 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is 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. * A score of 50 represents the population mean. * A score of 40 is one standard deviation lower than the mean of the reference population. * A score of 60 is one standard deviation higher than the mean of the reference population. * For PROMIS measures, higher scores for domains measuring symptoms is indicative of greater symptom burden. Therefore, higher scores are worse for fatigue, anxiety, depression, sleep disturbance, and pain interference. For the domains of Physical Function and Participation, higher scores indicate better function and better participation, respectively.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Depression | 49.2 T-score | Standard Deviation 7.9 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Sleep Disturbance | 46.8 T-score | Standard Deviation 9.9 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Anxiety | 49.7 T-score | Standard Deviation 8.1 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Participation | 46.3 T-score | Standard Deviation 8.4 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Fatigue | 47.8 T-score | Standard Deviation 8.7 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Pain Interference | 49.0 T-score | Standard Deviation 8.5 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Physical | 39.6 T-score | Standard Deviation 6.6 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Pain Interference | 47.4 T-score | Standard Deviation 6.9 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Physical | 40.1 T-score | Standard Deviation 5.8 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Anxiety | 49.9 T-score | Standard Deviation 8.3 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Depression | 48.9 T-score | Standard Deviation 7.6 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Fatigue | 48.0 T-score | Standard Deviation 8.6 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Sleep Disturbance | 45.5 T-score | Standard Deviation 9.9 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Participation | 45.8 T-score | Standard Deviation 8.5 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is 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. * A score of 50 represents the population mean. * A score of 40 is one standard deviation lower than the mean of the reference population. * A score of 60 is one standard deviation higher than the mean of the reference population. * For PROMIS measures, higher scores for domains measuring symptoms is indicative of greater symptom burden. Therefore, higher scores are worse for fatigue, anxiety, depression, sleep disturbance, and pain interference. For the domains of Physical Function and Participation, higher scores indicate better function and better participation, respectively.easured.
Time frame: end of treatment +6 months (8 months from Baseline)
Population: individuals with chronic stroke and residual upper limb paresis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Depression | 48.3 T-score | Standard Deviation 7.6 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Sleep Disturbance | 45.2 T-score | Standard Deviation 8.9 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Anxiety | 47.5 T-score | Standard Deviation 9 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Participation | 51.0 T-score | Standard Deviation 9.7 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Fatigue | 47.1 T-score | Standard Deviation 9.8 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Pain Interference | 51.3 T-score | Standard Deviation 8 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Physical | 42.0 T-score | Standard Deviation 7.6 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Pain Interference | 50.0 T-score | Standard Deviation 8.4 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Physical | 41.4 T-score | Standard Deviation 7.4 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Anxiety | 47.6 T-score | Standard Deviation 9 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Depression | 47.6 T-score | Standard Deviation 7.4 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Fatigue | 45.3 T-score | Standard Deviation 10.2 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Sleep Disturbance | 44.5 T-score | Standard Deviation 10.7 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Participation | 51.5 T-score | Standard Deviation 10.9 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is 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. * A score of 50 represents the population mean. * A score of 40 is one standard deviation lower than the mean of the reference population. * A score of 60 is one standard deviation higher than the mean of the reference population. * For PROMIS measures, higher scores for domains measuring symptoms is indicative of greater symptom burden. Therefore, higher scores are worse for fatigue, anxiety, depression, sleep disturbance, and pain interference. For the domains of Physical Function and Participation, higher scores indicate better function and better participation, respectively.
Time frame: end of treatment +1 year (14 months from Baseline)
Population: individuals with chronic stroke and residual upper limb paresis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Depression | 48.2 T-score | Standard Deviation 8.6 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Sleep Disturbance | 45.2 T-score | Standard Deviation 9.7 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Anxiety | 47.9 T-score | Standard Deviation 9.7 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Participation | 49.6 T-score | Standard Deviation 9.2 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Fatigue | 46.8 T-score | Standard Deviation 8.6 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Pain Interference | 49.4 T-score | Standard Deviation 8.6 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Physical | 41.1 T-score | Standard Deviation 6.8 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Pain Interference | 49.4 T-score | Standard Deviation 9.2 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Physical | 40.5 T-score | Standard Deviation 5.9 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Anxiety | 49.1 T-score | Standard Deviation 10.4 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Depression | 48.1 T-score | Standard Deviation 9.2 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Fatigue | 47.7 T-score | Standard Deviation 9.3 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Sleep Disturbance | 43.6 T-score | Standard Deviation 10.4 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Participation | 48.4 T-score | Standard Deviation 10.1 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is 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. * A score of 50 represents the population mean. * A score of 40 is one standard deviation lower than the mean of the reference population. * A score of 60 is one standard deviation higher than the mean of the reference population. * For PROMIS measures, higher scores for domains measuring symptoms is indicative of greater symptom burden. Therefore, higher scores are worse for fatigue, anxiety, depression, sleep disturbance, and pain interference. For the domains of Physical Function and Participation, higher scores indicate better function and better participation, respectively.
Time frame: end of treatment (8 weeks from Baseline)
Population: individuals with chronic stroke and residual upper limb paresis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Depression | 49.6 T-score | Standard Deviation 8.6 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Sleep Disturbance | 46.2 T-score | Standard Deviation 9 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Anxiety | 48.8 T-score | Standard Deviation 9.4 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Participation | 49.3 T-score | Standard Deviation 9.1 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Fatigue | 48.5 T-score | Standard Deviation 8.7 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Pain Interference | 49.7 T-score | Standard Deviation 8.8 |
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Physical | 40.8 T-score | Standard Deviation 6.5 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Pain Interference | 48.2 T-score | Standard Deviation 8.5 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Physical | 41.3 T-score | Standard Deviation 5.3 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Anxiety | 48.2 T-score | Standard Deviation 9.8 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Depression | 49.2 T-score | Standard Deviation 8.7 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Fatigue | 47.1 T-score | Standard Deviation 8.9 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Sleep Disturbance | 44.7 T-score | Standard Deviation 8.3 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Participation | 49.9 T-score | Standard Deviation 9.7 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity
The Patient-Reported Outcomes Measurement Information System includes pain rated on a 0-10 scale with higher scores indicative of greater pain.
Time frame: end of treatment + 12 months (14 months from baseline)
Population: individuals with chronic stroke and residual upper limb paresis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity | 2.7 units on a scale | Standard Deviation 2.8 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity | 2.7 units on a scale | Standard Deviation 2.3 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity
The Patient-Reported Outcomes Measurement Information System includes pain rated rated on a 0-10 scale with higher scores indicative of greater pain.
Time frame: Baseline
Population: individuals with chronic stroke and residual upper limb paresis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity | 2.4 units on a scale | Standard Deviation 2.1 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity | 2.4 units on a scale | Standard Deviation 2.3 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity
The Patient-Reported Outcomes Measurement Information System includes pain rated on a 0-10 scale with higher scores indicative of greater pain.
Time frame: end of treatment + 6 months (8 months from baseline)
Population: individuals with chronic stroke and residual upper limb paresis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity | 2.3 units on a scale | Standard Deviation 2.1 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity | 2.4 units on a scale | Standard Deviation 2 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity
The Patient-Reported Outcomes Measurement Information System includes pain rated on a 0-10 scale with higher scores indicative of greater pain.
Time frame: End of Treatment (8 weeks following baseline)
Population: individuals with chronic stroke and residual upper limb paresis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity | 2.3 units on a scale | Standard Deviation 2.6 |
| Upper Extremity Repetitive Task Practice Only | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity | 2.6 units on a scale | Standard Deviation 2.4 |
Secondary
Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.
Time frame: end of treatment (8 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Six-Minute Walk Test (6MWT) | 327.1 Meters | Standard Deviation 141.2 |
| Upper Extremity Repetitive Task Practice Only | Six-Minute Walk Test (6MWT) | 316.9 Meters | Standard Deviation 170 |
Secondary
Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Six-Minute Walk Test (6MWT) | 264.4 Meters | Standard Error 118.4 |
| Upper Extremity Repetitive Task Practice Only | Six-Minute Walk Test (6MWT) | 285.5 Meters | Standard Error 160.3 |
Secondary
Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.
Time frame: end of treatment +1 year (14 months from Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Six-Minute Walk Test (6MWT) | 320.8 Meters | Standard Deviation 166.5 |
| Upper Extremity Repetitive Task Practice Only | Six-Minute Walk Test (6MWT) | 336.7 Meters | Standard Deviation 170.3 |
Secondary
Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.
Time frame: end of treatment +6 months (8 months from Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Six-Minute Walk Test (6MWT) | 339.3 Meters | Standard Deviation 156.7 |
| Upper Extremity Repetitive Task Practice Only | Six-Minute Walk Test (6MWT) | 315.1 Meters | Standard Deviation 170.5 |
Secondary
Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.
Time frame: end of treatment +4 weeks (12 weeks from Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Six-Minute Walk Test (6MWT) | 339.3 units on a scale | Standard Deviation 156.7 |
| Upper Extremity Repetitive Task Practice Only | Six-Minute Walk Test (6MWT) | 315.1 units on a scale | Standard Deviation 170.5 |
Secondary
Stroke Impact Scale (SIS)
The Stroke Impact Scale is a self-reported questionnaire evaluating quality of life. 8 domains are assessed including: physical problems, memory and thinking, feelings, communication, activities of daily living (ADLs), mobility, hand use, and meaningful activities. Scores for all domains are normalized and range from 0-100, with higher scores indicating a better self-perceived quality of life. The last domain (stroke recovery) asks the individual to rate their recovery on a scale of 0-100, with 0 indicating no recovery and 100 indicating full recovery.
Time frame: end of treatment (8 weeks from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Memory and Thinking | 88.3 score on a scale | Standard Deviation 14.8 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Mobility | 84.4 score on a scale | Standard Deviation 12.7 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Communication | 87.6 score on a scale | Standard Deviation 17.6 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Hand Use | 54.5 score on a scale | Standard Deviation 26.4 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Feelings | 81.6 score on a scale | Standard Deviation 14.2 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Meaningful Activities | 73.8 score on a scale | Standard Deviation 19 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS ADLs | 76.9 score on a scale | Standard Deviation 13.8 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Stroke Recovery | 64.6 score on a scale | Standard Deviation 19.4 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Physical Problem | 58.4 score on a scale | Standard Deviation 14.9 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Stroke Recovery | 63.4 score on a scale | Standard Deviation 19.8 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Physical Problem | 54.8 score on a scale | Standard Deviation 22.6 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Memory and Thinking | 83.7 score on a scale | Standard Deviation 19.9 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Feelings | 77.6 score on a scale | Standard Deviation 16.5 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Communication | 88.9 score on a scale | Standard Deviation 17.2 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS ADLs | 74.4 score on a scale | Standard Deviation 16.2 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Mobility | 78.3 score on a scale | Standard Deviation 18.2 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Hand Use | 52.6 score on a scale | Standard Deviation 26.3 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Meaningful Activities | 69.8 score on a scale | Standard Deviation 17.7 |
Secondary
Stroke Impact Scale (SIS)
The Stroke Impact Scale is a self-reported questionnaire evaluating quality of life. 8 domains are assessed including: physical problems, memory and thinking, feelings, communication, activities of daily living (ADLs), mobility, hand use, and meaningful activities. Scores for all domains are normalized and range from 0-100, with higher scores indicating a better self-perceived quality of life. The last domain (stroke recovery) asks the individual to rate their recovery on a scale of 0-100, with 0 indicating no recovery and 100 indicating full recovery.
Time frame: end of treatment +1 year (14 months from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Memory and Thinking | 88.1 score on a scale | Standard Deviation 16.6 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Mobility | 83.3 score on a scale | Standard Deviation 12.6 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Communication | 88.8 score on a scale | Standard Deviation 19.2 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Hand Use | 49.0 score on a scale | Standard Deviation 28.1 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Feelings | 82.5 score on a scale | Standard Deviation 16.8 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Meaningful Activities | 69.3 score on a scale | Standard Deviation 26.9 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS ADL'S | 74.5 score on a scale | Standard Deviation 16.1 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Stroke Recovery Score | 65.7 score on a scale | Standard Deviation 20.6 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Physical Problem | 60.1 score on a scale | Standard Deviation 22.1 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Stroke Recovery Score | 66.9 score on a scale | Standard Deviation 22.8 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Physical Problem | 59.4 score on a scale | Standard Deviation 19.7 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Memory and Thinking | 90.9 score on a scale | Standard Deviation 11.6 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Feelings | 81.5 score on a scale | Standard Deviation 14.1 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Communication | 91.2 score on a scale | Standard Deviation 10.7 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS ADL'S | 77.0 score on a scale | Standard Deviation 14.4 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Mobility | 84.3 score on a scale | Standard Deviation 12.3 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Hand Use | 52.8 score on a scale | Standard Deviation 24.9 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Meaningful Activities | 73.0 score on a scale | Standard Deviation 19.2 |
Secondary
Stroke Impact Scale (SIS)
The Stroke Impact Scale is a self-reported questionnaire evaluating quality of life. 8 domains are assessed including: physical problems, memory and thinking, feelings, communication, activities of daily living (ADLs), mobility, hand use, and meaningful activities. Scores for all domains are normalized and range from 0-100, with higher scores indicating a better self-perceived quality of life. The last domain (stroke recovery) asks the individual to rate their recovery on a scale of 0-100, with 0 indicating no recovery and 100 indicating full recovery.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Memory and Thinking | 86.5 score on a scale | Standard Deviation 13.4 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Mobility | 81.5 score on a scale | Standard Deviation 12.9 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Communication | 87.2 score on a scale | Standard Deviation 19.4 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Hand Use | 41.9 score on a scale | Standard Deviation 27.2 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Feelings | 80.0 score on a scale | Standard Deviation 14.4 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Meaningful Activities | 61.4 score on a scale | Standard Deviation 23.8 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS ADL's | 73.4 score on a scale | Standard Deviation 14.5 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Stroke Recovery Score | 62.3 score on a scale | Standard Deviation 20.8 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Physical Problem | 50.6 score on a scale | Standard Deviation 17.1 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Stroke Recovery Score | 52.5 score on a scale | Standard Deviation 23.3 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Physical Problem | 47.8 score on a scale | Standard Deviation 19.4 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Memory and Thinking | 83.7 score on a scale | Standard Deviation 16.4 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Feelings | 69.8 score on a scale | Standard Deviation 18.7 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Communication | 83.9 score on a scale | Standard Deviation 18.8 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS ADL's | 67.8 score on a scale | Standard Deviation 18.8 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Mobility | 75.9 score on a scale | Standard Deviation 17.7 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Hand Use | 42.5 score on a scale | Standard Deviation 28.9 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Meaningful Activities | 63.0 score on a scale | Standard Deviation 25.8 |
Secondary
Stroke Impact Scale (SIS)
The Stroke Impact Scale is a self-reported questionnaire evaluating quality of life. 8 domains are assessed including: physical problems, memory and thinking, feelings, communication, activities of daily living (ADLs), mobility, hand use, and meaningful activities. Scores for all domains are normalized and range from 0-100, with higher scores indicating a better self-perceived quality of life. The last domain (stroke recovery) asks the individual to rate their recovery on a scale of 0-100, with 0 indicating no recovery and 100 indicating full recovery.
Time frame: end of treatment +6 months (8 months from Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS ADL's | 77.0 score on a scale | Standard Deviation 15.4 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Feelings | 83.5 score on a scale | Standard Deviation 12.7 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Mobility | 84.6 score on a scale | Standard Deviation 13.3 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Hand Use | 50.5 score on a scale | Standard Deviation 27.8 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Memory and Thinking | 87.3 score on a scale | Standard Deviation 15.1 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Meaningful Activities | 75.0 score on a scale | Standard Deviation 17.4 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Communication | 89.9 score on a scale | Standard Deviation 15.6 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Stroke Recovery Score | 68.0 score on a scale | Standard Deviation 17.7 |
| Aerobic Exercise & Repetitive Task Practice | Stroke Impact Scale (SIS) | SIS Physical Problem | 60.8 score on a scale | Standard Deviation 20.2 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Stroke Recovery Score | 66.5 score on a scale | Standard Deviation 21.5 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Physical Problem | 54.9 score on a scale | Standard Deviation 22.3 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Memory and Thinking | 85.3 score on a scale | Standard Deviation 15.2 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Feelings | 79.5 score on a scale | Standard Deviation 15.1 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Communication | 91.0 score on a scale | Standard Deviation 11 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS ADL's | 77.9 score on a scale | Standard Deviation 13.7 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Hand Use | 52.6 score on a scale | Standard Deviation 26.7 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Meaningful Activities | 67.6 score on a scale | Standard Deviation 20.3 |
| Upper Extremity Repetitive Task Practice Only | Stroke Impact Scale (SIS) | SIS Mobility | 80.8 score on a scale | Standard Deviation 14.4 |
Secondary
Walking Cadence
Steps walked per minute during two 2-minute walking trials
Time frame: Baseline
Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Walking Cadence | 82.1 steps/min | Standard Deviation 17.2 |
| Upper Extremity Repetitive Task Practice Only | Walking Cadence | 86.1 steps/min | Standard Deviation 17.3 |
Secondary
Walking Cadence
Steps walked per minute during two 2-minute walking trials
Time frame: end of treatment (8 weeks from Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Walking Cadence | 86.1 steps/min | Standard Deviation 17.3 |
| Upper Extremity Repetitive Task Practice Only | Walking Cadence | 85.8 steps/min | Standard Deviation 15.4 |
Secondary
Wolf Motor Function Test (WMFT)
The Wolf Motor Function Test includes 15 timed tasks for the affected upper extremity. Times for timed tasks are transformed and reported as geometric mean (standard deviation). Lower times indicate better performance.
Time frame: end of treatment (8 weeks from baseline)
Population: individuals with chronic stroke with residual upper limb paresis
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Wolf Motor Function Test (WMFT) | 8.2 time in seconds | Standard Deviation 3.3 |
| Upper Extremity Repetitive Task Practice Only | Wolf Motor Function Test (WMFT) | 10.0 time in seconds | Standard Deviation 3.7 |
Secondary
Wolf Motor Function Test (WMFT)
The Wolf Motor Function Test includes 15 timed tasks for the affected upper extremity. Times for timed tasks are transformed and reported as geometric mean (standard deviation). Lower times indicate better performance.
Time frame: Baseline
Population: individuals with chronic stroke with residual upper limb paresis
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Wolf Motor Function Test (WMFT) | 11.0 time in seconds | Standard Deviation 3 |
| Upper Extremity Repetitive Task Practice Only | Wolf Motor Function Test (WMFT) | 14.9 time in seconds | Standard Deviation 3.3 |
Secondary
Wolf Motor Function Test (WMFT) Functional Ability Score
The WMFT Functional Ability Score quantifies movement quality. Scores range from 0-75, with higher scores indicating a better outcome.
Time frame: Baseline
Population: individuals with chronic stroke with residual upper limb paresis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Wolf Motor Function Test (WMFT) Functional Ability Score | 2.4 score on a scale | Standard Deviation 1.1 |
| Upper Extremity Repetitive Task Practice Only | Wolf Motor Function Test (WMFT) Functional Ability Score | 2.7 score on a scale | Standard Deviation 1.2 |
Secondary
Wolf Motor Function Test (WMFT) Functional Ability Score
The Wolf Motor Function Test Functional Ability Score quantifies movement quality. Scores range from 0-75, with higher scores indicating a better outcome.
Time frame: End of Treatment (8 weeks from baseline)
Population: individuals with chronic stroke with residual upper limb paresis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Wolf Motor Function Test (WMFT) Functional Ability Score | 3.4 score on a scale | Standard Deviation 1.3 |
| Upper Extremity Repetitive Task Practice Only | Wolf Motor Function Test (WMFT) Functional Ability Score | 3.2 score on a scale | Standard Deviation 1.4 |
Secondary
Wolf Motor Function Test (WMFT) Grip Strength
The Wolf Motor Function Test includes Grip strength measured by dynamometer
Time frame: baseline
Population: individuals with chronic stroke with residual upper limb paresis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Wolf Motor Function Test (WMFT) Grip Strength | 13.8 kg | Standard Deviation 7.9 |
| Upper Extremity Repetitive Task Practice Only | Wolf Motor Function Test (WMFT) Grip Strength | 13.8 kg | Standard Deviation 8.9 |
Secondary
Wolf Motor Function Test (WMFT) Grip Strength
The Wolf Motor Function Test includes Grip strength measured by dynamometer
Time frame: End of Treatment (8 weeks from baseline)
Population: individuals with chronic stroke with residual upper limb paresis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Wolf Motor Function Test (WMFT) Grip Strength | 14.2 kg | Standard Deviation 8.5 |
| Upper Extremity Repetitive Task Practice Only | Wolf Motor Function Test (WMFT) Grip Strength | 14.1 kg | Standard Deviation 9 |
Secondary
Wolf Motor Function Test (WMFT) Weight to Box
The Wolf Motor Function Test includes the amount of weight the individual can lift onto a box using a wrist cuff weight ranging from 1-20 pounds. Higher indicates greater strength.
Time frame: End of Treatment (8 weeks from baseline)
Population: individuals with chronic stroke with residual upper limb paresis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Wolf Motor Function Test (WMFT) Weight to Box | 10.6 pounds | Standard Deviation 7 |
| Upper Extremity Repetitive Task Practice Only | Wolf Motor Function Test (WMFT) Weight to Box | 10.8 pounds | Standard Deviation 7.2 |
Secondary
Wolf Motor Function Test (WMFT) Weight to Box
The Wolf Motor Function Test includes the amount of weight the individual can lift onto a box using a wrist cuff weight ranging from 1-20 pounds. Higher indicates greater strength.
Time frame: baseline
Population: individuals with chronic stroke with residual upper limb paresis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Wolf Motor Function Test (WMFT) Weight to Box | 8.2 pounds | Standard Deviation 6.3 |
| Upper Extremity Repetitive Task Practice Only | Wolf Motor Function Test (WMFT) Weight to Box | 8.7 pounds | Standard Deviation 7.2 |