StrokeNCT03819764
Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation
A study testing Aerobic Exercise and Upper Extremity Repetitive Task Practice in people with Stroke and Cerebrovascular Disorders, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Cerebrovascular Disorders, Brain Diseases
- What is being tested?
- Aerobic Exercise and Upper Extremity Repetitive Task Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2019to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cost-effectiveness and Efficacy of a Combined Intervention to Facilitate Motor Recovery Following Stroke
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.
Read the 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.
- Conditions
- Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases
- Being tested
- Aerobic Exercise, Upper Extremity Repetitive Task Practice
- Keywords
- stroke, aerobic exercise, forced exercise, repetitive task practice, arm function, upper extremity
- Medical subject headings
- Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
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 PracticeBehavioural
Repetitive arm exercises
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Active comparator | Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises Receives: Behavioral: Aerobic Exercise; Behavioral: Upper Extremity Repetitive Task Practice |
| Upper Extremity Repetitive Task Practice Only | Active comparator | Participants will perform the following:
1. 90 minutes of upper extremity repetitive arm exercises Receives: Behavioral: Upper Extremity Repetitive Task Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: midpoint (4 weeks from Baseline)
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.
Measured: end of treatment (8 weeks from Baseline)
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.
Measured: end of treatment +4 weeks (12 weeks from Baseline)
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.
Measured: end of treatment +6 months (8 months from Baseline)
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.
Measured: end of treatment +1 year (14 months from Baseline)
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.
Measured: Baseline
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.
Measured: end of treatment (8 weeks from Baseline)
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.
Measured: end of treatment +4 weeks (12 weeks from Baseline)
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.
Measured: end of treatment +6 months (8 months from Baseline)
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.
Measured: end of treatment +1 year (14 months from Baseline)
Secondary outcomes (53)
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: end of treatment (8 weeks from Baseline)
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.
Measured: end of treatment +6 months (8 months from Baseline)
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.
Measured: end of treatment +1 year (14 months from Baseline)
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.
Measured: Baseline
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.
Measured: end of treatment (8 weeks from Baseline)
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.
Measured: end of treatment +6 months (8 months from Baseline)
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.
Measured: end of treatment +1 year (14 months from Baseline)
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.
Measured: Baseline
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.
Measured: end of treatment (8 weeks from Baseline)
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.
Measured: end of treatment +6 months (8 months from Baseline)
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.
Measured: end of treatment +1 year (14 months from Baseline)
Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.
Measured: Baseline
Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.
Measured: end of treatment (8 weeks)
Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.
Measured: end of treatment +4 weeks (12 weeks from Baseline)
Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.
Measured: end of treatment +6 months (8 months from Baseline)
Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.
Measured: end of treatment +1 year (14 months from Baseline)
Paretic Step Length
Mean Paretic step length (cm) across two 2-minute walking trials
Measured: Baseline
Non-Paretic Step Length
Mean Non-Paretic step length (cm) across two 2-minute walking trials
Measured: Baseline
Paretic Step Length
Mean Paretic step length (cm) across two 2-minute walking trials
Measured: end of treatment (8 weeks from Baseline)
Non-Paretic Step Length
Mean Non-Paretic step length (cm) across two 2-minute walking trials
Measured: end of treatment (8 weeks from Baseline)
Non-Paretic Single Limb Percentage
Percentage of gait cycle spent in single limb support
Measured: Baseline
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
Measured: end of treatment (8 weeks from Baseline)
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
- No significant disability despite symptoms; able to carry out all usual duties and activities
- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
- Moderate disability; requiring some help, but able to walk without assistance
- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- Severe disability; bedridden, incontinent and requiring constant nursing care and attention
- Dead
Measured: Baseline
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
- No significant disability despite symptoms; able to carry out all usual duties and activities
- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
- Moderate disability; requiring some help, but able to walk without assistance
- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- Severe disability; bedridden, incontinent and requiring constant nursing care and attention
- Dead
Measured: end of treatment (8 weeks from Baseline)
Walking Cadence
Steps walked per minute during two 2-minute walking trials
Measured: Baseline
Walking Cadence
Steps walked per minute during two 2-minute walking trials
Measured: end of treatment (8 weeks from Baseline)
Paretic Single Limb Percentage
Percentage of gait cycle spent in single limb support
Measured: Baseline
Paretic Single Limb Percentage
Percentage of gait cycle spent in single limb support
Measured: end of treatment (8 weeks from Baseline)
Paretic Knee Range of Motion
Mean peak degree of paretic knee flexion across two 2-minute walking trials
Measured: Baseline
Paretic Knee Range of Motion
Mean peak degree of paretic knee flexion across two 2-minute walking trials
Measured: end of treatment (8 weeks from Baseline)
Non-Paretic Knee Range of Motion
Mean peak degree of non-paretic knee flexion across two 2-minute walking trials
Measured: Baseline
Non-Paretic Knee Range of Motion
Mean peak degree of non-paretic knee flexion across two 2-minute walking trials
Measured: end of treatment (8 weeks from Baseline)
Paretic Ankle Range of Motion
Mean peak degree of paretic ankle dorsiflexion across two 2-minute walking trials
Measured: Baseline
Paretic Ankle Range of Motion
Mean peak degree of paretic ankle dorsiflexion across two 2-minute walking trials
Measured: end of treatment (8 weeks from Baseline)
Non-Paretic Ankle Range of Motion
Non-Paretic peak degree of non-paretic dorsiflexion across two 2-minute walking trials
Measured: Baseline
Non-Paretic Ankle Range of Motion
Mean peak degree of non-paretic ankle dorsiflexion across two 2-minute walking trials
Measured: end of treatment (8 weeks from Baseline)
Paretic Hip Range of Motion (Sagittal Plane)
Mean peak degree of paretic hip flexion across two 2-minute walking trials
Measured: Baseline
Paretic Hip Range of Motion (Sagittal Plane)
Mean peak degree of paretic hip flexion across two 2-minute walking trials
Measured: end of treatment (8 weeks from Baseline)
Non-Paretic Hip Range of Motion (Sagittal Plane)
Mean peak degree of non-paretic hip flexion across two 2-minute walking trials
Measured: Baseline
Non-Paretic Hip Range of Motion (Sagittal Plane)
Mean peak degree of non-paretic hip flexion across two 2-minute walking trials
Measured: end of treatment (8 weeks from Baseline)
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.
Measured: End of Treatment (8 weeks from baseline)
Wolf Motor Function Test (WMFT) Grip Strength
The Wolf Motor Function Test includes Grip strength measured by dynamometer
Measured: End of Treatment (8 weeks from baseline)
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.
Measured: End of Treatment (8 weeks from baseline)
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.
Measured: end of treatment (8 weeks from baseline)
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.
Measured: Baseline
Wolf Motor Function Test (WMFT) Grip Strength
The Wolf Motor Function Test includes Grip strength measured by dynamometer
Measured: baseline
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.
Measured: baseline
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.
Measured: End of Treatment (8 weeks following baseline)
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.
Measured: Baseline
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.
Measured: end of treatment + 6 months (8 months from baseline)
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.
Measured: end of treatment + 12 months (14 months from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start11 Apr 2019
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Linder, The Cleveland Clinic
- Investigators
- Susan Linder, DPT, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819764
- Sponsor's protocol ID
- 18-734
- Status last verified
- Jul 2025
- First submitted
- 17 Jan 2019
- Last updated
- 29 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Linder SM, Rilinger R, Learman K, Miller Koop M, Streicher M, Davidson S, Miller C, Harris D, Corrigan P, Bethoux F, Alberts JL. Forced-Rate Aerobic Cycling Improves Locomotor Function and Gait Biomechanics in Individuals With Chronic Stroke: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Dec 1;104(12):1147-1154. doi: 10.1097/PHM.0000000000002785. Epub 2025 Jul 4.
PubMed 40720308Linder SM, Bischof-Bockbrader A, Ince Hocaoglu OE, Bethoux F, Davidson S, Harris D, Li Y, Lapin B, Alberts JL. Task Practice With and Without Aerobic Exercise Improves Health-related Quality of Life and Social Participation Post-stroke: A Randomized Clinical Trial. Neurorehabil Neural Repair. 2025 Aug;39(8):591-601. doi: 10.1177/15459683251338784. Epub 2025 May 22.
PubMed 40401784Linder SM, Bischof-Bockbrader A, Davidson S, Li Y, Lapin B, Singh T, Lee J, Bethoux F, Alberts JL. The Utilization of Forced-Rate Cycling to Facilitate Motor Recovery Following Stroke: A Randomized Clinical Trial. Neurorehabil Neural Repair. 2024 Apr;38(4):291-302. doi: 10.1177/15459683241233577. Epub 2024 Feb 29.
PubMed 38420848Linder SM, Lee J, Bethoux F, Persson D, Bischof-Bockbrader A, Davidson S, Li Y, Lapin B, Roberts J, Troha A, Maag L, Singh T, Alberts JL. An 8-week Forced-rate Aerobic Cycling Program Improves Cardiorespiratory Fitness in Persons With Chronic Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 May;105(5):835-842. doi: 10.1016/j.apmr.2024.01.018. Epub 2024 Feb 11.
PubMed 38350494
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness and Efficacy of a Combined Intervention to Facilitate Motor Recovery Following Stroke
- ClinicalTrials.gov ID
- NCT03819764
- Acronym / sponsor ID
- 18-734
- Conditions
- Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases
- Keywords
- stroke, aerobic exercise, forced exercise, repetitive task practice, arm function, upper extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Posted 29 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise & Repetitive Task Practice | Active comparator | Behavioral: Aerobic Exercise, Behavioral: Upper Extremity Repetitive Task PracticeParticipants will perform the following: 1. 45 minutes of cycling 2. 45 minutes of upper extremity repetitive arm exercises |
| Upper Extremity Repetitive Task Practice Only | Active comparator | Behavioral: Upper Extremity Repetitive Task PracticeParticipants will perform the following: 1. 90 minutes of upper extremity repetitive arm exercises |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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.
Key exclusion criteria (8 listed)
- hospitalization for myocardial infarction, heart failure or heart surgery within 3 months,
- cardiac arrhythmia,
- hypertrophic cardiomyopathy,
- severe aortic stenosis,
- pulmonary embolus,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseCycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed | Behavioural | Aerobic Exercise & Repetitive Task Practice |
| Upper Extremity Repetitive Task PracticeRepetitive arm exercises | Behavioural | Aerobic Exercise & Repetitive Task Practice, Upper Extremity Repetitive Task Practice Only |
Primary outcome
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.
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: 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.
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.
53 secondary outcomes
Wolf Motor Function Test (WMFT)
Time frame: Baseline
Stroke Impact Scale (SIS)
Time frame: Baseline
Stroke Impact Scale (SIS)
Time frame: end of treatment (8 weeks from Baseline)
Stroke Impact Scale (SIS)
Time frame: end of treatment +6 months (8 months from Baseline)
Stroke Impact Scale (SIS)
Time frame: end of treatment +1 year (14 months from Baseline)
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: Baseline
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: end of treatment (8 weeks from Baseline)
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: end of treatment +6 months (8 months from Baseline)
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: end of treatment +1 year (14 months from Baseline)
Center for Epidemiological Studies-Depression (CES-D)
Time frame: Baseline
Center for Epidemiological Studies-Depression (CES-D)
Time frame: end of treatment (8 weeks from Baseline)
Center for Epidemiological Studies-Depression (CES-D)
Time frame: end of treatment +6 months (8 months from Baseline)
Center for Epidemiological Studies-Depression (CES-D)
Time frame: end of treatment +1 year (14 months from Baseline)
Six-Minute Walk Test (6MWT)
Time frame: Baseline
Six-Minute Walk Test (6MWT)
Time frame: end of treatment (8 weeks)
Six-Minute Walk Test (6MWT)
Time frame: end of treatment +4 weeks (12 weeks from Baseline)
Six-Minute Walk Test (6MWT)
Time frame: end of treatment +6 months (8 months from Baseline)
Six-Minute Walk Test (6MWT)
Time frame: end of treatment +1 year (14 months from Baseline)
Paretic Step Length
Time frame: Baseline
Non-Paretic Step Length
Time frame: Baseline
Paretic Step Length
Time frame: end of treatment (8 weeks from Baseline)
Non-Paretic Step Length
Time frame: end of treatment (8 weeks from Baseline)
Non-Paretic Single Limb Percentage
Time frame: Baseline
Non-Paretic Single Limb Percentage
Time frame: end of treatment (8 weeks from Baseline)
Modified Rankin Scale
Time frame: Baseline
Modified Rankin Scale
Time frame: end of treatment (8 weeks from Baseline)
Walking Cadence
Time frame: Baseline
Walking Cadence
Time frame: end of treatment (8 weeks from Baseline)
Paretic Single Limb Percentage
Time frame: Baseline
Paretic Single Limb Percentage
Time frame: end of treatment (8 weeks from Baseline)
Paretic Knee Range of Motion
Time frame: Baseline
Paretic Knee Range of Motion
Time frame: end of treatment (8 weeks from Baseline)
Non-Paretic Knee Range of Motion
Time frame: Baseline
Non-Paretic Knee Range of Motion
Time frame: end of treatment (8 weeks from Baseline)
Paretic Ankle Range of Motion
Time frame: Baseline
Paretic Ankle Range of Motion
Time frame: end of treatment (8 weeks from Baseline)
Non-Paretic Ankle Range of Motion
Time frame: Baseline
Non-Paretic Ankle Range of Motion
Time frame: end of treatment (8 weeks from Baseline)
Paretic Hip Range of Motion (Sagittal Plane)
Time frame: Baseline
Paretic Hip Range of Motion (Sagittal Plane)
Time frame: end of treatment (8 weeks from Baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40720308Linder SM, Rilinger R, Learman K, Miller Koop M, Streicher M, Davidson S, Miller C, Harris D, Corrigan P, Bethoux F, Alberts JL. Forced-Rate Aerobic Cycling Improves Locomotor Function and Gait Biomechanics in Individuals With Chronic Stroke: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Dec 1;104(12):1147-1154. doi: 10.1097/PHM.0000000000002785. Epub 2025 Jul 4.
- Derived from this study: PubMed 40401784Linder SM, Bischof-Bockbrader A, Ince Hocaoglu OE, Bethoux F, Davidson S, Harris D, Li Y, Lapin B, Alberts JL. Task Practice With and Without Aerobic Exercise Improves Health-related Quality of Life and Social Participation Post-stroke: A Randomized Clinical Trial. Neurorehabil Neural Repair. 2025 Aug;39(8):591-601. doi: 10.1177/15459683251338784. Epub 2025 May 22.
- Derived from this study: PubMed 38420848Linder SM, Bischof-Bockbrader A, Davidson S, Li Y, Lapin B, Singh T, Lee J, Bethoux F, Alberts JL. The Utilization of Forced-Rate Cycling to Facilitate Motor Recovery Following Stroke: A Randomized Clinical Trial. Neurorehabil Neural Repair. 2024 Apr;38(4):291-302. doi: 10.1177/15459683241233577. Epub 2024 Feb 29.
- Derived from this study: PubMed 38350494Linder SM, Lee J, Bethoux F, Persson D, Bischof-Bockbrader A, Davidson S, Li Y, Lapin B, Roberts J, Troha A, Maag L, Singh T, Alberts JL. An 8-week Forced-rate Aerobic Cycling Program Improves Cardiorespiratory Fitness in Persons With Chronic Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 May;105(5):835-842. doi: 10.1016/j.apmr.2024.01.018. Epub 2024 Feb 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Linder, DPT principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Upper Extremity Repetitive Task Practice in people with Stroke and Cerebrovascular Disorders, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (FMA) (time frame: Baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03819764, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.