I-Score: Intensive Stroke Cycling for Optimal Recovery and Economic Value
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe Cleveland Clinic
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
hospitalization for myocardial infarction, heart failure or heart surgery within 3 months
cardiac arrhythmia
hypertrophic cardiomyopathy
history of multiple strokes
Trial design
Design model
Parallel
Treatments tested in this trial
Forced Rate Exercise + Rehab
BehavioralThe 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).
Rehabilitation
BehavioralThe 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).
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Forced Rate Exercise + RehabilitationActive comparator 1 intervention
Group B: RehabilitationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Upper Extremity Fugl-Meyer Motor Assessment
Impairment-based measure of the upper extremity post-stroke.
Time frame
Baseline to end of treatment at 12 weeks and end of treatment + 6 months2
Gait Velocity
Gait velocity obtained using motion capture.
Time frame
Baseline to end of treatment at 12 weeks and end of treatment + 6 months3
Plasma IGF-1
Blood biomarker for neuroplasticity
Time frame
Before and after first and 24th treatment session4
Serum BDNF
Blood biomarker for neuroplasticity
Time frame
Before and after first and 24th treatment sessionSecondary outcomes
1
Action Research Arm Test
Measure of upper extremity gross and fine motor function post-stroke
Time frame
Baseline to end of treatment at 12 weeks and end of treatment + 6 months2
Biomechanical Dexterity Task
Force tracking task - accuracy within targeted range
Time frame
Baseline to end of treatment at 12 weeks and end of treatment + 6 months3
Biomechanical measure of maximum grasp force
maximum grasp force measured with force transducer
Time frame
Baseline to end of treatment at 12 weeks and end of treatment + 6 months4
Bimanual Dexterity Task
Time to complete task when separating 2 force transducers
Time frame
Baseline to end of treatment at 12 weeks and end of treatment + 6 monthsSponsors and contacts
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Source ClinicalTrials.gov