Robot-assisted Gait Training and Transcutaneous Spinal Cord Stimulation in Chronic Non-ambulatory Stroke Survivors: Pilot RCT Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Cardiac Output (Measured by Impedance Cardiography - BIOPAC MP160 System)
研究概览
简要总结
Rehabilitation interventions commonly used for stroke survivors include task-specific training, balance and strength exercises, and the use of assistive devices to enhance mobility and independence. Advanced technologies, such as body-weight-supported treadmill systems and robotic devices, may be employed when appropriate. Current rehabilitation therapies for stroke survivors are moderately effective with a limited effect size, especially in stroke survivors with severe impairment. Novel therapies, such as transcutaneous spinal cord stimulation (tSCS), may further improve outcomes in the target population. This pilot study will allow us to examine the feasibility and gather pilot data on a combined intervention of assistive gait training and tSCS in non-ambulatory stroke survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years at time of consent
- •All genders included.
- •Chronic ischemic or hemorrhagic stroke >=6 months, with limited within-home comfortable walking speed <= 0.49 m/s and unable to walk independently in community (FAC <= 3)
- •Able to communicate with investigators, follow 2-step command, and correctly answer consent comprehension questions in English.
- •Currently not participating in treadmill walking exercises or exercises involving weight-bearing activities.
- •Have physicians' approval for exercise and be in a stable medical condition
排除标准
- •Hospitalization for cardiac or pulmonary disease within the past 3 months
- •Have musculoskeletal disorders that prevent the participant from participating in the exercise
- •Blood pressure higher than 200/110 mm Hg
- •Significant ataxia or unilateral spatial neglect (score of 2 on NIH stroke scale item 7 or 11)
- •Reported pain that limits or interferes with activities of daily living and physical activity/exercise
- •Diagnosis of other neurological diseases (multiple sclerosis, Alzheimer's disease, Parkinson's disease)
- •Diagnosis of severe depression (HADS score 15-21)
- •Unable to speak or understand English, and travel to the research laboratory.
- •Contraindications to tSCS and TMS
结局指标
主要结局
Cardiac Output (Measured by Impedance Cardiography - BIOPAC MP160 System)
时间窗: Before and after 24 training sessions (8 weeks)
Cardiac output (L/min) will be measured using an impedance cardiography system (MP160, BIOPAC Systems Inc., Goleta, California). Measurements will be done during a 6-minute walk test. Data collection for each participant will occur at approximately the same time of day (between 9:00 AM and 11:00 AM) before the first intervention session and after completion of the 24th intervention session.
次要结局
未报告次要终点
研究者
Wen Liu, Ph.D.
Professor
University of Kansas Medical Center