NCT06585943 · The Cleveland Clinic
I-Score: Intensive Stroke Cycling for Optimal Recovery and Economic Value
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Forced Rate Exercise + Rehab
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).
BEHAVIORAL
Rehabilitation
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).
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- will be recruited from the Cleveland Clinic:
- 3-9 months following single ischemic or hemorrhagic stroke confirmed with neuroimaging (ie: first-time stroke)
- Fugl-Meyer motor score 19-55 in the involved UE
- Fugl-Meyer score \<34 in the involved LE demonstrating residual hemiparesis
- Ambulatory ≥ 20 meters with no more than contact guard assistance
- 18-85 years of age
Exclusion criteria
- 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
- 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
Where
- Cleveland, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 16, 2025 · Source of record for eligibility and locations