The I-Score (Intensive Stroke Cycling for Optimal Recovery and Economic Value) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Upper Extremity Fugl-Meyer Motor Assessment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor will be blinded to group allocation
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Forced Rate Exercise + Rehabilitation
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).
干预措施: Forced Rate Exercise + Rehab (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).
干预措施: Rehabilitation (Behavioral)
结局指标
主要结局
Upper Extremity Fugl-Meyer Motor Assessment
时间窗: 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
时间窗: Baseline to end of treatment at 12 weeks and end of treatment + 6 months
Gait velocity obtained using motion capture.
Plasma IGF-1
时间窗: Before and after first and 24th treatment session
Blood biomarker for neuroplasticity
Serum BDNF
时间窗: Before and after first and 24th treatment session
Blood biomarker for neuroplasticity
electroencephalograms
时间窗: 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
Incremental cost-effectiveness ratio
时间窗: 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
时间窗: 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
次要结局
- Bimanual Dexterity Task(Baseline to end of treatment at 12 weeks and end of treatment + 6 months)
- Action Research Arm Test(Baseline to end of treatment at 12 weeks and end of treatment + 6 months)
- Biomechanical Dexterity Task(Baseline to end of treatment at 12 weeks and end of treatment + 6 months)
- Biomechanical measure of maximum grasp force(Baseline to end of treatment at 12 weeks and end of treatment + 6 months)
- Six minute walk test(Baseline to end of treatment at 12 weeks and end of treatment + 6 months)
- Lower Extremity Fugl-Meyer Motor Assessment(Baseline to end of treatment at 12 weeks and end of treatment + 6 months)
- Plasma BDNF(Before and after first and 24th session)
- Somatosensory evoked potentials(Baseline)
- Modified Rankin Scale(Baseline to end of treatment at 12 weeks and end of treatment + 6 months)
- Peak oxygen consumption (Peak VO2)(Baseline to end of treatment at 12 weeks)
- 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)
- 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)
- Biomechanical Gait Analysis(Baseline, end of treatment at 12 weeks, end of treatment + 6 months)
研究者
Susan Linder
Associate Professor
The Cleveland Clinic