Transcutaneous Spinal Stimulation With Intensive Gait Training for Individuals With Neurologic Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline - Six Minute Walk Test
研究概览
简要总结
The purpose of the study is to evaluate whether non-invasive stimulation over the spinal cord at the neck and/or lower back can improve walking function for people with neurologic conditions. Spinal stimulation has been used extensively for individuals with spinal cord injury, and has demonstrated improvements in function. This study will extend this work to other neurologic conditions, such as cerebral palsy and stroke, that also demonstrate similar impairments as spinal cord injury.
The primary aims of this study are to:
Aim 1: Evaluate impact of spinal stimulation on spasticity and locomotor function.
Aim 2: Investigate participant perceptions of spinal stimulation.
The investigators will be using a cross-over design study to compare intensive training only to intensive training combined with spinal stimulation. After an initial baseline period of up to 4 weeks (Phase I). Participants will have their first intervention phase of the study (Phase II). This will involve either intensive training only (Condition A) or intensive training combined with spinal stimulation (Condition B). This will be followed by a washout period with no intervention (Phase III) and then the second intervention phase (Phase IV). The second intervention phase will involve either Condition A or Condition B, whichever the participants did not received during Phase II. Phases II-IV will each last up to 8 weeks. After the intervention period is complete, the participant will be asked to come for follow-up visits up to 3 months after the intervention phases are completed (Phase V).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have a neurologic condition
- •can walk 20 yards, with or without an assistive device
- •have stable medical condition
- •are capable of performing simple cued motor tasks and who can follow 2-3 step commands
- •have ability to attend up to 5 sessions per week physical therapy sessions and testing activities
- •have adequate social support to be able to participate in training and assessment sessions, up to 5 sessions per week, for the duration of up to 11 months within the study period.
- •who are volunteering to be involved in this study
- •can read and speak English
排除标准
- •have significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation.
- •have cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
- •have a history of uncontrolled seizures
- •have unhealed fracture or other musculoskeletal impairment that might interfere with lower extremity rehabilitation or testing activities
- •are dependent on ventilation support
- •have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc) or drug delivery device (e.g. baclofen pump)
- •have history of orthopedic surgery in lower extremities or neurosurgery that may be a confounding factor for interpretation of the results (such as tendon transfer, tendon or muscle lengthening for spasticity management, injection therapies to lower extremity muscles, etc.) in last 12 months
- •have established osteoporosis and taking medication for osteoporosis treatment.
- •have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- •have active cancer
结局指标
主要结局
Change from baseline - Six Minute Walk Test
时间窗: Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
Measure of walking ability. The distance is reported in meters.
Change from baseline - Ten Meter Walk Test
时间窗: Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
The measure of walking ability at fast and self-selected speeds. The walking speed is reported as meters per second.
次要结局
- Change from baseline - Timed Up and Go(Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.)
- Change from baseline - Modified Ashworth and Tardieu Scales(Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.)
- Change from baseline - Patient-Reported Outcomes Measurement Information System Pediatric Profile(Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.)
- Change from baseline - Electromyography recording of lower extremity muscles(Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.)
- Change from baseline - Kinetic and kinematic gait analysis using three dimensional camera system(Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.)
- Change from baseline - Gait Outcomes Assessment List(Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.)
研究者
Chet Moritz
Associate Professor of Electrical & Computer Engineering and Rehabilitation Medicine
University of Washington