A Neuroprosthesis for Seated Posture and Balance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility.
研究概览
简要总结
The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.
详细描述
In a single surgical procedure electrodes will be inserted into muscles of the trunk and hip musculature. The electrode leads are connected to a stimulator/telemeter located in the abdomen. After a typical post-operative period of two to five days, neuroprosthesis recipients will be discharged to home for two to six weeks of restricted activity to promote healing of all surgical incisions. After a period of exercise and training, functional use of the neuroprosthesis will begin. Laboratory assessments of strength, balance, and functional abilities with and without the system, as well as the technical performance of the implanted components will be evaluated.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASIA Scale A through C
- •Time post injury greater than 6 months
- •Innervated and excitable trunk and pelvis musculature
- •Absence of acute or chronic psychological problems or chemical dependency
- •Range of motion within normal limits
- •Controlled spasticity and absence of hip flexion and adduction spasm
- •Height and weight within normal limits
- •No history of balance problems or spontaneous falls
- •No history of spontaneous fracture or evidence low bone density
- •No acute orthopaedic problems
- •No acute medical complications
- •Adequate social support and stability
- •Able to speak and read English
排除标准
- •Pregnancy
- •Non-English speaking
结局指标
主要结局
Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility.
时间窗: up to 36 months
Experiments involving the effects of trunk stimulation on postural alignment; trunk stability and posture on respiration, postural variation on seated interface pressures; effects of trunk stimulation on reaching ability; effects of trunk stimulation on seated stability, and personal mobility.
次要结局
- Design a simple position controller(Up to 36 months)