I-Score: Intensive Stroke Cycling for Optimal Recovery and Economic Value
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Forced Rate Exercise + Rehab, Rehabilitation.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The I-Score (Intensive Stroke Cycling for Optimal Recovery and Economic Value) Trial
Overview
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.
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 functi - 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]
- Gait Velocity [Time frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months]
- Plasma IGF-1 [Time frame: Before and after first and 24th treatment session]
- Serum BDNF [Time frame: Before and after first and 24th treatment session]
- electroencephalograms [Time frame: Baseline and end of treatment at 12 weeks]
- electroencephalograms [Time frame: Baseline and end of treatment at 12 weeks]
- electroencephalograms [Time frame: Baseline and end of treatment at 12 weeks]
- Incremental cost-effectiveness ratio [Time frame: baseline to end of treatment at 12 weeks and baseline to end of treatment + 6 months]
- Stroke Impact Scale [Time frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Sixty-six individuals with chronic stroke able to provide informed consent who meet the following criteria for inclusion 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 include:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cleveland Clinic — Cleveland
Identifiers
NCT: NCT06585943 · IRB 23-1262