Evaluation of Advanced Lower Extremity Neuroprostheses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge
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 exercise, standing, stepping and/or balance in people with various degrees of paralysis.
详细描述
Protocol Outline: Patents undergo surgery in which electrodes are implanted into muscles of the trunk and legs. Electrode leads are connected to an stimulator/telemeter. Following implantation, patients undergo training in standing, transfers and other advanced mobility skills using the functional electrical stimulation system. A prescribed course of exercise, functional training and rehabilitation with the implanted stimulation system, followed by laboratory assessments of strength, balance and functional abilities with and without the system, as well as the technical performance of the implanted components. Home-based training follows prior to discharge for home use of the system.
Patients are followed at 6 and 12 months after discharge and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phase I Inclusion Criteria
- •Skeletal maturity and ability to sign informed consent (>18 years)
- •Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs
- •Innervated and excitable lower extremity and trunk musculature
- •Adequate social support and stability
- •Willingness to comply with follow-up procedures
排除标准
- •Non-English speaking
- •Females who are pregnant
- •Current pressure injuries that would be exacerbated by study activities
- •Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities
- •History of spontaneous fractures or other evidence of excessively low bone density
- •History of vestibular dysfunction, balance problems, or spontaneous falls
- •Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.
研究组 & 干预措施
Implant
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: IST (Implanted Stimulator-Telemeter) (Device)
结局指标
主要结局
Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge
时间窗: Change from immediately after intervention and 1 year after intervention
Repeated measures of walking distance in meters
Device reliability and technical performance measuring changes in standing loads from baseline at discharge to 12 months after discharge
时间窗: Change from immediately after intervention and 1 year after intervention
Repeated measures of arm/leg loading measured in Kg
Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge
时间窗: Change from immediately after intervention and 1 year after intervention
Repeated measures of standing duration in minutes
Device reliability and technical performance measuring changes in walking duration from baseline at discharge to 12 months after discharge
时间窗: Change from immediately after intervention and 1 year after intervention
Repeated measures of walking time in minutes
次要结局
- Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge(Change from immediately after intervention and 1 year after intervention)
研究者
Ronald J. Triolo
Biomedical Engineer
Case Western Reserve University