Understanding and Enhancing Human Health and Movement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Difference in Max Standing Time
研究概览
简要总结
By doing this study, investigators hope to learn how electrical stimulation can improve human movement, biomechanics, and function and to gather information on the safety and effectiveness of an implanted electrical stimulation system after paralysis from spinal cord injury, stroke, multiple sclerosis, and traumatic brain injury.
详细描述
The purpose of this research study is to better understand how people move, so investigators can develop improved ways to help individuals with lower-limb and/or trunk paralysis perform everyday activities such as sitting, reaching, pushing a wheelchair, transferring, standing, stepping, and maintaining balance.
This study evaluates how activating stabilizing muscles, either with surface electrical stimulation or with an implanted neural stimulation device may change the way these daily activities are performed and potentially enhance functional independence.
A key goal of this project is to collect information on the safety and effectiveness of an implanted neural stimulation system. The U.S. Food and Drug Administration (FDA) permits the limited investigational use of this implanted system for individuals with lower-limb and/or trunk paralysis resulting from neurological conditions.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Time post injury greater than six months
- •Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
- •Neurologically stable as determined by a physician
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.
- •Acute and/or chronic problems left untreated or not controlled that would put a participant at risk by using stimulation such as cardiac abnormalities, immunological/pulmonary/renal/circulatory compromise, diabetes or hypertension
- •Presence of a demand pacemaker or cardiac defibrillator
- •Any other medical or psychological condition that would be a contraindication
- •Current pressure ulcers
- •Significant range of motion limitations that would compromise study activities
- •Body habitus that would compromise study activities
结局指标
主要结局
Difference in Max Standing Time
时间窗: Study completion - an average of 1 year
Difference in Max Walking distance
时间窗: Study completion - an average of 1 year
次要结局
未报告次要终点
研究者
Nathan Makowski
Principal Investigator
Louis Stokes VA Medical Center