I-Score: Intensive Stroke Cycling for Optimal Recovery and Economic Value
- Conditions
- Stroke
- Interventions
- Behavioral: Forced Rate Exercise + RehabBehavioral: Rehabilitation
- Registration Number
- NCT06585943
- Lead Sponsor
- The Cleveland Clinic
- Brief 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 66
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Forced Rate Exercise + Rehabilitation Forced Rate Exercise + Rehab 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). Rehabilitation 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
Name Time Method Upper Extremity Fugl-Meyer Motor Assessment 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 Baseline to end of treatment at 12 weeks and end of treatment + 6 months Gait velocity obtained using motion capture.
Plasma IGF-1 Before and after first and 24th treatment session Blood biomarker for neuroplasticity
Serum BDNF Before and after first and 24th treatment session Blood biomarker for neuroplasticity
electroencephalograms 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 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 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
- Secondary Outcome Measures
Name Time Method Action Research Arm Test Baseline to end of treatment at 12 weeks and end of treatment + 6 months Measure of upper extremity gross and fine motor function post-stroke
Biomechanical Dexterity Task Baseline to end of treatment at 12 weeks and end of treatment + 6 months Force tracking task - accuracy within targeted range
Biomechanical measure of maximum grasp force Baseline to end of treatment at 12 weeks and end of treatment + 6 months maximum grasp force measured with force transducer
Bimanual Dexterity Task Baseline to end of treatment at 12 weeks and end of treatment + 6 months Time to complete task when separating 2 force transducers
Six minute walk test Baseline to end of treatment at 12 weeks and end of treatment + 6 months Measure of walking capacity
Lower Extremity Fugl-Meyer Motor Assessment Baseline to end of treatment at 12 weeks and end of treatment + 6 months Impairment-based measure of the lower extremity post-stroke.
Biomechanical Gait Analysis Baseline, end of treatment at 12 weeks, end of treatment + 6 months Biomechanical assessment of the following kinematic components of gait using motion capture: hip flexion/extension, knee flexion/extension, ankle plantar- and dorsi-flexion
Plasma BDNF Before and after first and 24th session Blood biomarker for neuroplasticity
Somatosensory evoked potentials Baseline lower extremity somatosensory evoked potentials
Modified Rankin Scale Baseline to end of treatment at 12 weeks and end of treatment + 6 months Measure of disability
Peak oxygen consumption (Peak VO2) Baseline to end of treatment at 12 weeks Measure of cardiorespiratory function
Patient-Reported Outcomes Measurement Information System (PROMIS) Computerized Adaptive Test (CAT) v 2.0 Physical Function Baseline to end of treatment at 12 weeks and end of treatment + 6 months 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
Patient-Reported Outcomes Measurement Information System (PROMIS) Computerized Adaptive Test (CAT) v 2.0 Ability to Participate in Social Roles Baseline to end of treatment at 12 weeks and end of treatment + 6 months Self-reported quality of life measure computed as a normalized T-score (0-100 range), with higher scores indicative of greater self-reported participation
Trial Locations
- Locations (1)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States