Restoring Walking With a Powered Exoskeleton After Complete and Sever Incomplete Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Physiological Cost Index (PCI) Ratio
研究概览
简要总结
Powered exoskeletons have emerged recently, promising to offer walking to individuals with severe spinal cord injury who are unable to walk. We will use the ReWalk exoskeleton to train walking in individuals with chronic, severe spinal cord injury (SCI). We will determine the characteristics of individuals who most benefit from such training, and identify the neuroplasticity induced by the training. We will further determine the feasibility of the ReWalk for home and community ambulation.
详细描述
A prospective, pilot, cohort study design will recruit participants to train intensively for a 3 month period. The training sessions will be documented in detail, including number of steps taken, speed of walking, distance of walking. Once walking speed has plateaued, we will evaluate the feasibility of using the device in a home-like environment and in the community.
At the end of this study, we will have a good idea of the capability of the ReWalk to assist walking in those with severe spinal cord injury. We will better understand which individuals are most likely to benefit from the ReWalk. We will know how training in the ReWalk changes the neural connections between the brain and the spinal cord so that we can better guide the training protocol. Finally, we will identify limitations of the ReWalk for home and community use, so that exoskeletons can be improved in the future to maximize their benefit to people with spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-progressive spinal cord injury ≥1 year post-injury
- •Body height between 5'3" and 6'4"
- •Body weight ≤82 kg
- •Uses wheelchair as primary mode of mobility
- •If able to walk, walks at ≤0.4 m/s
- •Arm strength sufficient to control forearm crutches
- •Agree to attend intensive training of 1.5 hr/day, 4 days/wk for 14 weeks, plus testing pre and post training of approximately 2 weeks each
排除标准
- •Contractures at the hip, knee or ankle that interferes with fitting into the ReWalk
- •Fractures within the last 2 years
- •Osteoporosis in the legs (t-score ≤-3.0)
- •Severe postural hypotension
- •Severe spasticity that interferes with use of the ReWalk
- •Active pressure sores
- •Pregnancy
- •Severe head injury
- •Conditions that preclude intensive exercise (such as high blood pressure)
- •Presence of conditions contraindicated for transcranial magnetic stimulation
结局指标
主要结局
Physiological Cost Index (PCI) Ratio
时间窗: End of training:12-14 weeks from baseline
PCI is defined as the change in heart rate from the average at rest to the average in the last two minutes of the 6 minute walk test is divided by the average speed during the last two minutes of walking to give a measure of heartbeats/minute. The ratio between this measure while walking in the Rewalk and the same measure while performing the test using a wheelchair will be calculated. (Walk/wheelchair)
次要结局
- 10 Meter Walk Test(End of training (at 12 weeks for 10 participants and 6 weeks for 1) and at follow-up (2-3 months from end of training))
- Limits of Stability - Sitting(Baseline, Mid point-6 weeks from baseline, End training:12-14 weeks from baseline)
- Spinal Cord Assessment Tool for Spastic Reflexes (SCATS)(Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline)
- Motor Evoked Potentials(Baseline, End training:12-14 weeks from baseline)
- Sitting Sway(Baseline, Mid-point:6 weeks from baseline, End training:12-14 weeks from baseline)
- Change From Baseline in Manual Muscle Test at End of Training(Baseline, end training:12 -14 weeks from baseline)
- Max Distance(End of training:12-14 weeks from baseline)
- McGill Pain Questionnaire(Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline)