Task-specific Epidural Stimulation and Training for Recovery of Stepping, Standing and Voluntary Movement Following Severe Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change from baseline of number of consecutive hip flexion repetitions performed within one minute after 160 sessions (1 year)
研究概览
简要总结
This study will determine the level of functional gain, below the injury for voluntary control of movements, and recovery standing and stepping function as a result of activation of spinal circuits with scES in humans with severe paralysis. Training will consist of practicing stepping, standing and voluntary movements in the presence of specific scES configurations designed specific for stepping (Step-scES), specific for standing (Stand-scES) and for the voluntary movements of the legs and trunk (Vol-scES). Ability to step, stand, move voluntarily, as well as cardiovascular, respiratory, bladder, bowel and sexual function will be assessed in these individuals with chronic severe 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
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-progressive SCI
- •at least 2 years post injury
- •stable medical condition
- •inability to walk independently overground
- •unable to voluntarily move all individual joints of the legs
排除标准
- •ventilator dependent
- •untreated painful musculoskeletal dysfunction, fracture or pressure sore
- •untreated psychiatric disorder or ongoing drug abuse
- •cardiovascular, respiratory, bladder, or renal disease unrelated to SCI
- •pregnant at the time of enrollment or planning to become pregnant during the time course of the study
研究组 & 干预措施
Stand, Step and Voluntary Training
干预措施: Standing and Stepping (Other)
Stand, Step and Voluntary Training
干预措施: Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation (Device)
结局指标
主要结局
Change from baseline of number of consecutive hip flexion repetitions performed within one minute after 160 sessions (1 year)
时间窗: Baseline, 160 sessions (1 year)
We will measure the ability of the individuals to perform consecutive hip flexion repetitions with stimulation during a 1-minute period
Change from baseline of lower extremity independence time during 10 min standing bout after 160 sessions (1 year)
时间窗: Baseline, 160 sessions (1 year)
We will measure the amount of time individuals are able to stand without manual assistance (independently) throughout a 10 min bout
Change from baseline of stepping independence time during 6 min stepping bout after 160 sessions (1 year)
时间窗: Baseline, 160 sessions (1 year)
We will measure the number of steps individuals are able to take without manual assistance (independently) throughout a 6 min stepping bout
次要结局
- Change from baseline in resting metabolic rate after 160 sessions (1 year)(Baseline, 160 sessions (1 year))
- Change from baseline in forced vital capacity (FVC) after 160 sessions (1 year)(Baseline, 160 sessions (1 year))
- Change in baseline in sexual function after 160 sessions (1 year)(Baseline, 160 sessions (1 year))
- Change from baseline in mean squeeze pressure after 160 sessions (1 year)(Baseline, 160 sessions (1 year))
- Change from baseline in mean squeeze increase pressure after 160 sessions (1 year)(Baseline, 160 sessions (1 year))
- Change from baseline in bowel sensation after 160 sessions (1 year)(Baseline, 160 sessions (1 year))
- Change from baseline in maximum inspiratory pressure (MIP) after 160 sessions (1 year)(Baseline, 160 sessions (1 year))
- Change in baseline in maximum expiratory pressure (MEP) after 160 sessions (1 year)(Baseline, 160 sessions (1 year))
- Change from baseline in detrusor pressures during filling after 160 sessions (1 year)(Baseline, 160 sessions (1 year))
- Change from baseline in forced expiratory volume in one second (FEV1) after 160 sessions (1 year)(Baseline, 160 sessions (1 year))
- Change from baseline in bladder capacity after 160 sessions (1 year)(Baseline, 160 sessions (1 year))
- Change from baseline in bladder voiding efficiency after 160 sessions (1 year)(Baseline, 160 sessions (1 year))
- Change from baseline in mean resting anal pressure after 160 sessions (1 year)(Baseline, 160 sessions (1 year))
- Change from baseline in squeeze anal canal length after 160 sessions (1 year)(Baseline, 160 sessions (1 year))
- Change from baseline in bladder compliance after 160 sessions (1 year)(Baseline, 160 sessions (1 year))
研究者
Susan Harkema PhD
Professor
University of Louisville