Cortical Priming to Optimize Gait Rehabilitation Post Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Change in gait speed using 10 meter walk test
研究概览
简要总结
Over four million stroke survivors currently living in the United States are unable to walk independently in the community. To increase the effectiveness of gait rehabilitation, it is critical to develop therapies that are based on an understanding of brain adaptations that occur after stroke. This project will be the first step towards the development of a novel therapeutic approach using brain stimulation to increase walking capacity in stroke survivors and understand the neural mechanisms that are associated with impairment and functional recovery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 - 80 years
- •First ever monohemispheric stroke > 6 months since onset
- •Residual hemiparetic gait deficits
- •Able to walk without an ankle orthotic for 5 minutes at self-paced speed. Handheld assistive device is acceptable.
排除标准
- •Severe osteoporosis
- •Contracture-limiting range of motion of lower limb
- •Uncontrolled anti-spasticity medications during the study period
- •Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema)
- •Unhealed decubiti, persistent infection
- •Significant cognitive or communication impairment (MMSE <21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the tracking task.
- •Lesions pertaining to the brainstem and cerebellum
结局指标
主要结局
Change in gait speed using 10 meter walk test
时间窗: Change from baseline to immediately after training and baseline to 3 months follow up
10-meter walk test: Gait speed will be measured as the average of 3 trials of the 10-m walk test. Participants will be asked to walk at their normal comfortable pace to cover a distance of 10 meters without an AFO (handheld assistive device is acceptable if needed).
次要结局
- Change in Quality of life measures(Change from baseline to immediately after training and baseline to 3 months follow up)
- Change in 6 minute walk test(Change from baseline to immediately after training and baseline to 3 months follow up)
- Change in cortical excitability of leg muscles using TMS(Change from baseline to immediately after training and baseline to 3 months follow up)
- Change in Berg Balance Scale(Change from baseline to immediately after training and baseline to 3 months follow up)
研究者
Sangeetha Madhavan
Associate Professor
University of Illinois at Chicago