Improving Ambulatory Community Access After Paralysis
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- The effect of functional electrical stimulation of the hip, knee and ankle muscles to improve walking in people with partial paralysis
研究概览
简要总结
The purpose of this research study is to evaluate the effectiveness of functional electrical stimulation (FES) provided by an implanted pulse generator (IPG) in correcting hip, knee and ankle function to improve walking in people with partial paralysis.
详细描述
In a surgical procedure electrodes are inserted into muscles of the lower extremities to correct hip, knee and ankle function. The electrode leads are connected to an implanted pulse generator located in the abdomen. After a typical post-operative period of two to five days, the recipient will be discharged home for two to six weeks of moderate activity. Following a 6 week period of laboratory exercise and training, functional use of the neuroprosthesis will begin at home and in the community with follow-up evaluations at 1, 3, 6 and 12 months. Laboratory assessments include walking speed and distance, physiologic cost, muscle strength, measure of spasticity, and gait analysis with and without stimulation. A number of self-reporting instruments are administered to capture individual's participation, quality of life and various aspects of perceived community ambulation.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •problems walking because of paralysis for more than 6 months
- •weak hip flexors and extensors or excessive tone
- •weak ankle dorsiflexors (muscles bringing the foot up)
- •weak plantar flexors (ankle muscles for push-off)
- •foot drop that is causing "dragging" or "catching" toes during walking
- •swinging the leg sideways or hiking the hip to clear affected leg during stepping
- •endurance to walk at least 10 ft with minimal assistance
- •hip extension range to neutral
- •hip flexion range greater or equal to 90 degrees
- •ankle range to neutral
- •sufficient upper extremity function to use a walking aid
- •muscles respond to electrical stimulation
排除标准
- •cardiac arrythmias
- •demand pacemaker
- •pregnancy
- •Parkinson's disease
- •traumatic brain injury
- •autoimmune deficiency
- •uncontrolled diabetes
- •significant edema of the affected limb
- •active pressure ulcers or open wounds
- •sepsis or an active infection
- •severe osteoporosis
- •uncontrolled seizures
- •moderate depression
研究组 & 干预措施
Experimental
Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures
干预措施: IRS-8 (8 channel implanted receiver stimulator) (Device)
结局指标
主要结局
The effect of functional electrical stimulation of the hip, knee and ankle muscles to improve walking in people with partial paralysis
时间窗: up to 36 months
Experiments involving analyses of individual's speed, distance and quality of walking will be performed both with and without stimulation to determine if individuals are able to improve community ambulatory access with use of neuroprosthesis.
次要结局
- Feasibility of initiating a step with a trigger from an accelerometer incorporated in the external control unit to adjust to environmental circumstances and situations encountered in community ambulation(up to 36 months)
研究者
Rudi Kobetic
Biomedical Engineer
Louis Stokes VA Medical Center