Cost-effectiveness and Efficacy of a Combined Intervention to Facilitate Motor Recovery Following Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Action Research Arm Test (ARAT)
研究概览
简要总结
The purpose of this study is to investigate whether aerobic exercise improves the participant's ability to recover function in the arm and leg affected by the participant's stroke. The investigators are also calculating the cost effectiveness of the rehabilitation interventions.
详细描述
The aims of the study are to determine the clinical efficacy and cost-effectiveness of combining aerobic exercise training with upper extremity motor task practice to improve motor recovery following stroke. It is hypothesized that the neurophysiologic impact of aerobic exercise may augment motor recovery associated with motor task practice. To test this hypothesize, 60 individuals with chronic stroke will be recruited to participate in this randomized clinical trial. Following screening and informed consent, all participants will undergo an exercise stress test to determine response to maximal exertion. Following the stress test, baseline clinical assessments will be obtained to quantify upper extremity function, gait, endurance, and self-reported quality of life. Additionally, variables to determine degree of disability will be obtained. Individuals will be randomized to one of two interventions: 45 min of forced-rate aerobic exercise paired with 45 min of upper limb repetitive task practice or two back-to-back 45-minute sessions of upper limb repetitive task practice. The interventions will occur 3 times per week for 8 weeks. Outcomes assessing motor function and disability will be repeated at mid-treatment, end of treatment, and at 4 weeks, 6-months and 12-months following end of treatment.
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)
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
- •≥ 6 months following single ischemic or hemorrhagic stroke confirmed with neuroimaging,
- •Fugl-Meyer motor score 19-55 in the involved upper extremity,
- •Ambulatory ≥ 20 meters with no more than contact guard assistance, and
- •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,
- •severe aortic stenosis,
- •pulmonary embolus,
- •significant contractures,
- •anti-spasticity injection within 3 months of enrollment and
- •other contraindication to exercise
结局指标
主要结局
Action Research Arm Test (ARAT)
时间窗: end of treatment +1 year (14 months from Baseline)
The Action Research Arm Test is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome. The test includes 4 subscales: grasp (6 items, score range 0-18), grip (4 items, score range 0-12), pinch (6 items, score range 0-18), and gross motor (3 items, score range 0-9 ) which are added up for the total score. For all subscales, higher scores indicate better function.
Fugl-Meyer Assessment (FMA)
时间窗: end of treatment +1 year (14 months from Baseline)
The Fugl-Meyer Assessment is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
Action Research Arm Test (ARAT)
时间窗: end of treatment +1 year (14 months from Baseline)
The Action Research Arm Test is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome. The test includes 4 subscales: grasp (6 items, score range 0-18), grip (4 items, score range 0-12), pinch (6 items, score range 0-18), and gross motor (3 items, score range 0-9 ) which are added up for the total score. For all subscales, higher scores indicate better function.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS-29)(end of treatment +1 year (14 months from Baseline))
- Center for Epidemiological Studies-Depression (CES-D)(end of treatment +1 year (14 months from Baseline))
- Wolf Motor Function Test (WMFT)(end of treatment (8 weeks from baseline))
- Stroke Impact Scale (SIS)(end of treatment +1 year (14 months from Baseline))
- Patient-Reported Outcomes Measurement Information System (PROMIS-29)(end of treatment +1 year (14 months from Baseline))
- Center for Epidemiological Studies-Depression (CES-D)(end of treatment +1 year (14 months from Baseline))
- Six-Minute Walk Test (6MWT)(end of treatment +1 year (14 months from Baseline))
- Paretic Step Length(end of treatment (8 weeks from Baseline))
- Non-Paretic Step Length(end of treatment (8 weeks from Baseline))
- Non-Paretic Single Limb Percentage(end of treatment (8 weeks from Baseline))
- Modified Rankin Scale(end of treatment (8 weeks from Baseline))
- Walking Cadence(end of treatment (8 weeks from Baseline))
- Paretic Single Limb Percentage(end of treatment (8 weeks from Baseline))
- Paretic Knee Range of Motion(end of treatment (8 weeks from Baseline))
- Non-Paretic Knee Range of Motion(end of treatment (8 weeks from Baseline))
- Paretic Ankle Range of Motion(end of treatment (8 weeks from Baseline))
- Non-Paretic Ankle Range of Motion(end of treatment (8 weeks from Baseline))
- Paretic Hip Range of Motion (Sagittal Plane)(end of treatment (8 weeks from Baseline))
- Non-Paretic Hip Range of Motion (Sagittal Plane)(end of treatment (8 weeks from Baseline))
- Wolf Motor Function Test (WMFT) Functional Ability Score(Baseline)
- Wolf Motor Function Test (WMFT) Grip Strength(baseline)
- Wolf Motor Function Test (WMFT) Weight to Box(baseline)
- Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity(end of treatment + 12 months (14 months from baseline))
研究者
Susan Linder
Project Scientist, Principle Investigator
The Cleveland Clinic