Exoskeleton Use in Acute Rehab Post Spinal Cord Injury; a Safety and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change from baseline cardiorespiratory status throughout each of the 25 sessions
研究概览
简要总结
This study will examine the safety and feasibility of using an exoskeleton in subjects who are less than 6 months post spinal cord injury (SCI).
详细描述
Study participants with acute SCI (<6 months post injury) will be involved in an indoor, overground walking program.
Locomotor training will include 90 minute sessions (including time to don and doff the device) for 30 training hours (90 minutes, 2-3 times weekly for 8 weeks.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 15 and older with acute SCI (<6 months post) Etiology of SCI can be traumatic or non traumatic Includes motor complete (AIS A,B) and motor incomplete (AIS C,D) at C7 or below.
- •Participants must be able to follow 2 step commands Participants must be deemed medically stable by responsible physician or physiatrist
- •Spine considered stable by surgeon
- •Surgical wound is approximated and surrounding tissue appears healthy
- •Participant does not require supplemental Oxygen
- •Participant is able to have any IV or other lines disconnected.
- •Must meet manufacturer's requirements for use of Ekso GT:
排除标准
- •Range of motion (ROM) restrictions that would prevent a patient from achieving a normal, reciprocal gait pattern, or would restrict a patient from completing normal sit-to-stand or stand-to-sit transitions Spinal instability Untreated deep vein thrombosis (DVT) Decreased standing tolerance due to orthostatic hypotension Significant osteoporosis that prevents safe standing or may increase the risk of fracture caused by standing or walking Uncontrolled spasticity - score of 3 or higher on modified Ashworth Scale Uncontrolled Autonomic Dysreflexia (AD) Skin integrity issues on contact surfaces of the device or on surfaces that would prohibit sitting (sacrum, greater trochanter, proximal tibia)
- •Upper leg length discrepancy greater than half an inch (> .5") or lower leg discrepancy greater than three-quarters of an inch (>.75") Cognitive impairments resulting in motor planning or impulsivity concerns Pregnancy
研究组 & 干预措施
Overground walking program
Study participant will be involved in an indoor, overground walking program using an exoskeleton wearable walking device under the supervision of a physiotherapist.
干预措施: Exoskeleton (Device)
结局指标
主要结局
Change from baseline cardiorespiratory status throughout each of the 25 sessions
时间窗: Every 15 minutes during each training session including: pre and post initial stand, at 15 minute intervals during training and at the end of each of the 25 total sessions, on average of 2 months
Blood pressure, heart rate and peripheral oxygen saturation and will be used to identify any cardiovascular issues of orthostatic hypotension or autonomic dysreflexia.
次要结局
- Skin integrity(At the beginning and end of each training session for 25 sessions, on average of 2 months)
- Falls(From onset to cessation of each training session for 25 sessions, on average of 2 months)
- Pain visual analogue scale(At the beginning and end of each training session for 25 sessions, on average of 2 months)
- Borg scale of perceived exertion(At the beginning, mid point (30 min) and end (60 min) of each training session for 25 sessions, on average of 2 months)
- 10 meter walk test(Training sessions 1, 13 and 25 out of the 25 total sessions, on average of 2 months)
- 6 minute walk test(Training sessions 1, 13 and 25 of the 25 total sessions, on average of 2 months)
研究者
Chester Ho, MD
Associate Professor
University of Calgary