StrokeNCT06585943
I-Score: Intensive Stroke Cycling for Optimal Recovery and Economic Value
A study testing Forced Rate Exercise + Rehab and Rehabilitation in people with Stroke, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Traditional rehabilitation approaches are time and personnel intensive and costly, and leave ~75% of stroke survivors with residual disability. We propose a clinical trial to determine effects of forced aerobic exercise (FE; i.e., mechanically supplemented) in facilitating upper and lower extremity motor recovery… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Forced Rate Exercise + Rehab and Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2024to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- hospitalization for myocardial infarction, heart failure or heart surgery within 3 months
- cardiac arrhythmia
- hypertrophic cardiomyopathy
- history of multiple strokes
- actively undergoing physical or occupational therapy or enrolled in another interventional study
- severe aortic stenosis
Show all 17Show fewer
- untreated deep vein thrombosis or pulmonary embolus
- unstable angina
- uncontrolled hypertension
- implanted pacemaker or defibrillator
- dyspnea at rest
- clinically significant neurologic condition/diagnosis other than stroke
- recent history of elicit drug or alcohol misuse or significant mental health illness
- significant contractures
- anti-spasticity injection within 3 months of enrollment
- skull hardware (e.g. screws/plates) or prior craniotomies that could shunt current flow altering EEG measures
- other contraindication to exercise or EEGs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Courtney R Miller, DPT, 216-509-7012, millerc5@ccf.org
Donayja Harris, BS, harrisd47@ccf.org
About this study
Official title: The I-Score (Intensive Stroke Cycling for Optimal Recovery and Economic Value) Trial
Traditional rehabilitation approaches are time and personnel intensive and costly, and leave ~75% of stroke survivors with residual disability. We propose a clinical trial to determine effects of forced aerobic exercise (FE; i.e., mechanically supplemented) in facilitating upper and lower extremity motor recovery post-stroke in an outpatient rehabilitation setting, to elucidate neural and biochemical substrates of FE-induced motor recovery, and to evaluate cost effectiveness of a FE-centered intervention compared to traditional stroke rehabilitation. The global effect of FE has the potential to enhance recovery in a growing population of stroke survivors in a cost-effective manner, thus accelerating its clinical acceptance.
Read the detailed description
Traditional rehabilitation approaches following stroke involve 1:1 motor learning-based training to facilitate recovery of upper extremity (UE) and lower extremity (LE) function. These time- and personnel-intensive approaches are costly, yet leave ~75% of stroke survivors with residual disability. More effective alternative approaches to facilitate motor recovery following stroke have not been adopted clinically due to excessive time and cost. To advance clinical care, both effectiveness and cost of a candidate intervention must be considered simultaneously. Aerobic exercise (AE) is known to improve cardiovascular function following stroke and central nervous system (CNS) function in older adults and neurological populations. Strong theoretical arguments suggest that AE may facilitate motor recovery following stroke. A protocol that rigorously tests this theory in the subacute stroke population is warranted. Animal studies, coupled with our preliminary data, indicate a specific type of exercise - forced aerobic exercise (FE), where volitional movements are mechanically supplemented - improves motor recovery following stroke. The mechanical assistance provided by FE enables patients to achieve a more rapid and consistent exercise pattern beyond their volitional capabilities while maintaining their aerobic effort within a beneficial range. In our initial studies, persons completing FE cycling followed by a reduced dose of UE motor task practice exhibited greater recovery of UE motor function compared to those completing unassisted AE and motor task practice or extended sessions of motor task practice alone. Animal studies have shown that FE triggers the release of brain-derived neurotrophic factor (BDNF) and insulin-like growth factor-1 (IGF-1), thought to be critical building blocks for neuroplasticity. Project Hypothesis: FE facilitates high-intensity AE, which triggers growth factors essential for neuroplasticity, thereby 'priming' the CNS to facilitate motor recovery associated with motor retraining therapies. We propose a prospective, pragmatic clinical trial to determine effects of FE in facilitating UE and LE motor recovery post-stroke in an outpatient rehabilitation setting, to elucidate neural and biochemical substrates of FE-induced motor recovery, and to evaluate cost effectiveness of a FE-centered intervention compared to traditional stroke rehabilitation.
Aim 1: Determine effects of FE+rehab vs. time-matched rehab on the recovery of UE motor function.
Aim 2: Determine effects of FE+rehab vs. time-matched rehab on recovery of lower extremity motor function.
Aim 3: Determine effects of FE+rehab vs. rehab on electrophysiological and biochemical markers of neuroplasticity.
Aim 4: Evaluate cost-effectiveness of FE+rehab vs. rehab. The global effect of FE has the potential to enhance recovery in a growing population of stroke survivors in a cost-effective manner, thus accelerating its clinical acceptance. Our mechanistic aim will elucidate the effects of each approach on substrates underlying neuroplasticity.
- Conditions
- Stroke
- Being tested
- Forced Rate Exercise + Rehab, Rehabilitation
- Keywords
- aerobic exercise, physical therapy, occupational therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced Rate Exercise + RehabBehavioural
The FE+rehab group (N=33) will complete FE on the cycle designed to augment pedaling rate to >75 RPM. Target heart rate zone will be set to 60-80% of HR reserve. The session will consist of a 5-min warm-up, 35-min main exercise set, and 5-min cool down. Following FE, abbreviated sessions of motor learning-based training will be administered by a neurologic OT and PT experienced in stroke rehabilitation, with 30 min focused on restoration of UE function (OT) and 15 min focused on LE motor function/ gait training (PT).
RehabilitationBehavioural
The rehab group will receive consecutive, full-length sessions of motor learning-based training, administered by a neurologic OT and PT experienced in stroke rehabilitation, with 45 min focused on restoration of UE function (OT) and 45 min focused on LE motor function/ gait training (PT).
| Study group | Role | What they receive |
|---|---|---|
| Forced Rate Exercise + Rehabilitation | Active comparator | The forced rate exercise+rehab group (N=33) will complete FE on the cycle designed to augment pedaling rate to >75 revolutions per minute (RPM). Target heart rate zone will be set to 60-80% of heart rate (HR) reserve. The session will consist of a 5-min warm-up, 35-min main exercise set, and 5-min cool down. Following FE, abbreviated sessions of motor learning-based training will be administered by a neurologic OT and PT experienced in stroke rehabilitation, with 30 min focused on restoration of UE function (OT) and 15 min focused on LE motor function/ gait training (PT). Receives: Behavioral: Forced Rate Exercise + Rehab |
| Rehabilitation | Active comparator | The rehab group will receive consecutive, full-length sessions of motor learning-based training, administered by a neurologic OT and PT experienced in stroke rehabilitation, with 45 min focused on restoration of UE function (OT) and 45 min focused on LE motor function/ gait training (PT). Receives: Behavioral: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Fugl-Meyer Motor Assessment
Impairment-based measure of the upper extremity post-stroke.
Measured: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Gait Velocity
Gait velocity obtained using motion capture.
Measured: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Plasma IGF-1
Blood biomarker for neuroplasticity
Measured: Before and after first and 24th treatment session
Serum BDNF
Blood biomarker for neuroplasticity
Measured: Before and after first and 24th treatment session
electroencephalograms
Electroencephalograms will be obtained to determine the degree of active engagement of different cortical areas during active/passive UE and LE movements
Measured: Baseline and end of treatment at 12 weeks
electroencephalograms
Electroencephalograms will be obtained to determine the degree of active engagement of different cortical areas under each cycling condition
Measured: Baseline and end of treatment at 12 weeks
electroencephalograms
Electroencephalograms will be obtained to quantify inter-area communication and direction of information flow.
Measured: Baseline and end of treatment at 12 weeks
Incremental cost-effectiveness ratio
Incremental cost-effectiveness ratio (ICER) expressed as cost per quality of life years (QALY) will be computed using a healthcare perspective.
Measured: baseline to end of treatment at 12 weeks and baseline to end of treatment + 6 months
Stroke Impact Scale
Self-reported quality of life measure, normalized to a score from 0-100 with higher scores indicative of better self-reported quality of life
Measured: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Secondary outcomes (19)
Action Research Arm Test
Measure of upper extremity gross and fine motor function post-stroke
Measured: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Biomechanical Dexterity Task
Force tracking task - accuracy within targeted range
Measured: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Biomechanical measure of maximum grasp force
maximum grasp force measured with force transducer
Measured: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Bimanual Dexterity Task
Time to complete task when separating 2 force transducers
Measured: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Six minute walk test
Measure of walking capacity
Measured: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Lower Extremity Fugl-Meyer Motor Assessment
Impairment-based measure of the lower extremity post-stroke.
Measured: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Biomechanical Gait Analysis
Biomechanical assessment of the following spatio-temporal components of gait using motion capture: % of gait cycle spent in swing and stance phases, and in single and double limb support.
Measured: Baseline, end of treatment at 12 weeks, end of treatment + 6 months
Biomechanical Gait Analysis
Biomechanical assessment of gait cadence (steps/minute)
Measured: Baseline, end of treatment at 12 weeks, end of treatment + 6 months
Biomechanical Gait Analysis
Biomechanical assessment of stride length
Measured: Baseline, end of treatment at 12 weeks, end of treatment + 6 months
Biomechanical Gait Analysis
Biomechanical assessment of the following components of gait kinetics using motion capture: 1) peak anterior-posterior propulsion forces, 2) peak anterior-posterior braking forces, 3) peak vertical ground reaction forces, 4) peak lateral ground reaction forces.
Measured: Baseline, end of treatment at 12 weeks, end of treatment + 6 months
Biomechanical Gait Analysis
Biomechanical assessment of the following components of gait kinetics using motion capture: 1) total hip extension moment 2) total knee extension moment, 3) total ankle plantarflexion extension moment
Measured: Baseline, end of treatment at 12 weeks, end of treatment + 6 months
Biomechanical Gait Analysis
Biomechanical assessment of the following components of gait kinetics during stance phase using motion capture: 1) total hip extension power 2) total knee extension power, 3) total ankle plantarflexion extension power
Measured: Baseline, end of treatment at 12 weeks, end of treatment + 6 months
Biomechanical Gait Analysis
Biomechanical assessment of the following kinematic components of gait using motion capture: hip flexion/extension, knee flexion/extension, ankle plantar- and dorsi-flexion
Measured: Baseline, end of treatment at 12 weeks, end of treatment + 6 months
Plasma BDNF
Blood biomarker for neuroplasticity
Measured: Before and after first and 24th session
Somatosensory evoked potentials
lower extremity somatosensory evoked potentials
Measured: Baseline
Modified Rankin Scale
Measure of disability
Measured: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Peak oxygen consumption (Peak VO2)
Measure of cardiorespiratory function
Measured: Baseline to end of treatment at 12 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Computerized Adaptive Test (CAT) v 2.0 Physical Function
Self-reported quality of life measure of physical function computed as normalized T-scores (1-100 range), with higher scores indicative of greater self-reported quality of life
Measured: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Computerized Adaptive Test (CAT) v 2.0 Ability to Participate in Social Roles
Self-reported quality of life measure computed as a normalized T-score (0-100 range), with higher scores indicative of greater self-reported participation
Measured: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start18 Sep 2024
- Primary completionOct 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- prospective, single-center, parallel group, rater-blind, pragmatic randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
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, PT, DPT, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585943
- Sponsor's protocol ID
- IRB 23-1262
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The I-Score (Intensive Stroke Cycling for Optimal Recovery and Economic Value) Trial
- ClinicalTrials.gov ID
- NCT06585943
- Acronym / sponsor ID
- IRB 23-1262
- Conditions
- Stroke
- Keywords
- aerobic exercise, physical therapy, occupational therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Traditional rehabilitation approaches are time and personnel intensive and costly, and leave ~75% of stroke survivors with residual disability. We propose a clinical trial to determine effects of forced aerobic exercise (FE; i.e., mechanically supplemented) in facilitating upper and lower extremity motor recovery post-stroke in an outpatient rehabilitation setting, to elucidate neural and biochemical substrates of FE-induced motor recovery, and to evaluate cost effectiveness of a FE-centered intervention compared to traditional stroke rehabilitation. The global effect of FE has the potential to enhance recovery in a growing population of stroke survivors in a cost-effective manner, thus accelerating its clinical acceptance.
Detailed description
Traditional rehabilitation approaches following stroke involve 1:1 motor learning-based training to facilitate recovery of upper extremity (UE) and lower extremity (LE) function. These time- and personnel-intensive approaches are costly, yet leave ~75% of stroke survivors with residual disability. More effective alternative approaches to facilitate motor recovery following stroke have not been adopted clinically due to excessive time and cost. To advance clinical care, both effectiveness and cost of a candidate intervention must be considered simultaneously. Aerobic exercise (AE) is known to improve cardiovascular function following stroke and central nervous system (CNS) function in older adults and neurological populations. Strong theoretical arguments suggest that AE may facilitate motor recovery following stroke. A protocol that rigorously tests this theory in the subacute stroke population is warranted. Animal studies, coupled with our preliminary data, indicate a specific type of exercise - forced aerobic exercise (FE), where volitional movements are mechanically supplemented - improves motor recovery following stroke. The mechanical assistance provided by FE enables patients to achieve a more rapid and consistent exercise pattern beyond their volitional capabilities while maintaining their aerobic effort within a beneficial range. In our initial studies, persons completing FE cycling followed by a reduced dose of UE motor task practice exhibited greater recovery of UE motor function compared to those completing unassisted AE and motor task practice or extended sessions of motor task practice alone. Animal studies have shown that FE triggers the release of brain-derived neurotrophic factor (BDNF) and insulin-like growth factor-1 (IGF-1), thought to be critical building blocks for neuroplasticity. Project Hypothesis: FE facilitates high-intensity AE, which triggers growth factors essential for neuroplasticity, thereby 'priming' the CNS to facilitate motor recovery associated with motor retraining therapies. We propose a prospective, pragmatic clinical trial to determine effects of FE in facilitating UE and LE motor recovery post-stroke in an outpatient rehabilitation setting, to elucidate neural and biochemical substrates of FE-induced motor recovery, and to evaluate cost effectiveness of a FE-centered intervention compared to traditional stroke rehabilitation.
Aim 1: Determine effects of FE+rehab vs. time-matched rehab on the recovery of UE motor function.
Aim 2: Determine effects of FE+rehab vs. time-matched rehab on recovery of lower extremity motor function.
Aim 3: Determine effects of FE+rehab vs. rehab on electrophysiological and biochemical markers of neuroplasticity.
Aim 4: Evaluate cost-effectiveness of FE+rehab vs. rehab. The global effect of FE has the potential to enhance recovery in a growing population of stroke survivors in a cost-effective manner, thus accelerating its clinical acceptance. Our mechanistic aim will elucidate the effects of each approach on substrates underlying neuroplasticity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, single-center, parallel group, rater-blind, pragmatic randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Forced Rate Exercise + Rehabilitation | Active comparator | Behavioral: Forced Rate Exercise + RehabThe forced rate exercise+rehab group (N=33) will complete FE on the cycle designed to augment pedaling rate to >75 revolutions per minute (RPM). Target heart rate zone will be set to 60-80% of heart rate (HR) reserve. The session will consist of a 5-min warm-up, 35-min main exercise set, and 5-min cool down. Following FE, abbreviated sessions of motor learning-based training will be administered by a neurologic OT and PT experienced in stroke rehabilitation, with 30 min focused on restoration of UE function (OT) and 15 min focused on LE motor function/ gait training (PT). |
| Rehabilitation | Active comparator | Behavioral: RehabilitationThe rehab group will receive consecutive, full-length sessions of motor learning-based training, administered by a neurologic OT and PT experienced in stroke rehabilitation, with 45 min focused on restoration of UE function (OT) and 45 min focused on LE motor function/ gait training (PT). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- hospitalization for myocardial infarction, heart failure or heart surgery within 3 months
- cardiac arrhythmia
- hypertrophic cardiomyopathy
- history of multiple strokes
- actively undergoing physical or occupational therapy or enrolled in another interventional study
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 |
|---|---|---|
| Forced Rate Exercise + RehabThe FE+rehab group (N=33) will complete FE on the cycle designed to augment pedaling rate to >75 RPM. Target heart rate zone will be set to 60-80% of HR reserve. The session will consist of a 5-min warm-up, 35-min main exercise set, and 5-min cool down. Following FE, abbreviated sessions of motor learning-based training will be administered by a neurologic OT and PT experienced in stroke rehabilitation, with 30 min focused on restoration of UE function (OT) and 15 min focused on LE motor function/ gait training (PT). | Behavioural | Forced Rate Exercise + Rehabilitation |
| RehabilitationThe rehab group will receive consecutive, full-length sessions of motor learning-based training, administered by a neurologic OT and PT experienced in stroke rehabilitation, with 45 min focused on restoration of UE function (OT) and 45 min focused on LE motor function/ gait training (PT). | Behavioural | Rehabilitation |
Primary outcome
Upper Extremity Fugl-Meyer Motor Assessment
Time frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Impairment-based measure of the upper extremity post-stroke.
Gait Velocity
Time frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Gait velocity obtained using motion capture.
Plasma IGF-1
Time frame: Before and after first and 24th treatment session
Blood biomarker for neuroplasticity
Serum BDNF
Time frame: Before and after first and 24th treatment session
Blood biomarker for neuroplasticity
electroencephalograms
Time frame: Baseline and end of treatment at 12 weeks
Electroencephalograms will be obtained to determine the degree of active engagement of different cortical areas during active/passive UE and LE movements
electroencephalograms
Time frame: Baseline and end of treatment at 12 weeks
Electroencephalograms will be obtained to determine the degree of active engagement of different cortical areas under each cycling condition
electroencephalograms
Time frame: Baseline and end of treatment at 12 weeks
Electroencephalograms will be obtained to quantify inter-area communication and direction of information flow.
Incremental cost-effectiveness ratio
Time frame: baseline to end of treatment at 12 weeks and baseline to end of treatment + 6 months
Incremental cost-effectiveness ratio (ICER) expressed as cost per quality of life years (QALY) will be computed using a healthcare perspective.
Stroke Impact Scale
Time frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Self-reported quality of life measure, normalized to a score from 0-100 with higher scores indicative of better self-reported quality of life
19 secondary outcomes
Action Research Arm Test
Time frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Biomechanical Dexterity Task
Time frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Biomechanical measure of maximum grasp force
Time frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Bimanual Dexterity Task
Time frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Six minute walk test
Time frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Lower Extremity Fugl-Meyer Motor Assessment
Time frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Biomechanical Gait Analysis
Time frame: Baseline, end of treatment at 12 weeks, end of treatment + 6 months
Biomechanical Gait Analysis
Time frame: Baseline, end of treatment at 12 weeks, end of treatment + 6 months
Biomechanical Gait Analysis
Time frame: Baseline, end of treatment at 12 weeks, end of treatment + 6 months
Biomechanical Gait Analysis
Time frame: Baseline, end of treatment at 12 weeks, end of treatment + 6 months
Biomechanical Gait Analysis
Time frame: Baseline, end of treatment at 12 weeks, end of treatment + 6 months
Biomechanical Gait Analysis
Time frame: Baseline, end of treatment at 12 weeks, end of treatment + 6 months
Biomechanical Gait Analysis
Time frame: Baseline, end of treatment at 12 weeks, end of treatment + 6 months
Plasma BDNF
Time frame: Before and after first and 24th session
Somatosensory evoked potentials
Time frame: Baseline
Modified Rankin Scale
Time frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Peak oxygen consumption (Peak VO2)
Time frame: Baseline to end of treatment at 12 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Computerized Adaptive Test (CAT) v 2.0 Physical Function
Time frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Computerized Adaptive Test (CAT) v 2.0 Ability to Participate in Social Roles
Time frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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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.
Susan Linder, PT, DPT, PhD 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 Forced Rate Exercise + Rehab and Rehabilitation in people with Stroke, 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 0 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Miller, PT, DPT (216 509-7012, millerc5@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Extremity Fugl-Meyer Motor Assessment (time frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2026.