Mechanisms of Walking Recovery After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Walking Speed
研究概览
简要总结
Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week control period and a 4-week exercise intervention.
详细描述
Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week control period and a 4-week exercise intervention using high-intensity interval training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes Assessor was blinded to study design, including when participant was in control phase versus intervention phase
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 30-90 years
- •unilateral stroke experienced >6 months prior to enrollment in middle cerebral artery (MCA) territory without complete disruption of the putamen on the lesion side
- •walking speed <= 1.0 m/s on the 10 meter walk test
- •able to walk 10m over ground with assistive devices as needed and no physical assistance
排除标准
- •MRI incompatibility (e.g. metallic or electronic implants, severe claustrophobia)
- •inability to perform mental imagery (time dependent motor imagery screening test [TDMI])
- •evidence of significant arrhythmia or myocardial ischemia on treadmill ECG stress test, or significant baseline ECG abnormalities that would make an exercise ECG uninterpretable
- •recent (<3 months) cardiopulmonary hospitalization
- •unable to communicate with investigators or correctly answer consent comprehension questions
- •significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
- •severe lower extremity (LE) spasticity (Ashworth >2)
- •recent (<3 months) illicit drug or alcohol abuse or significant mental illness
- •major post-stroke depression (PHQ-9 ≥10) in the absence of medical management
- •participating in physical therapy or another interventional research study;
- •recent (<3 months) paretic LE botulinum toxin injection
- •concurrent progressive neurologic disorder or other major medical, orthopedic or peripheral vascular conditions that would limit improvement
- •pregnancy
研究组 & 干预措施
Arm 1
4-week control period with no intervention and 4-weeks of high-intensity interval training
干预措施: No intervention (Behavioral)
Arm 1
4-week control period with no intervention and 4-weeks of high-intensity interval training
干预措施: High-intensity interval training (Behavioral)
结局指标
主要结局
Walking Speed
时间窗: Change from 4-weeks to 8-weeks
10-meter walk test
次要结局
- Gait Symmetry(baseline, 4 weeks, 8 weeks)
- NIH Toolbox Standing Balance Test(baseline, 4 weeks, 8 weeks)
- Brain Locomotor Network Activation(baseline, 4 weeks, 8 weeks)
- Daily Walking Activity(baseline, 4 weeks, 8 weeks)
- Walking Speed(baseline, 4 weeks, 8 weeks)
- NIH Toolbox - Cognition Domain(baseline, 4 weeks, 8 weeks)
- Metabolic Cost of Gait(baseline, 4 weeks, 8 weeks)
- Aerobic Capacity(baseline, 4 weeks, 8 weeks)
- Brain Locomotor Network Connectivity(baseline, 4 weeks, 8 weeks)
- Stroke and Aphasia Quality of Life Scale(baseline, 4 weeks, 8 weeks)
- Walking Capacity(baseline, 4 weeks, 8 weeks)
研究者
Pierce Boyne
Assistant Professor
University of Cincinnati