Exoskeleton Use in Acute Rehab Post Spinal Cord Injury; a Safety and Feasibility Study
2019年5月14日 更新者：Chester Ho, MD、University of Calgary
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).
研究概览
详细说明
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.)
研究类型
介入性
注册 (实际的)
11
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Alberta
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Calgary、Alberta、加拿大、T2N2T9
- Foothills Medical Centre
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
15年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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:
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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This is an open study and so all participants involved with be using the exoskeleton to determine the safety and feasibility of its use during the acute rehabilitation phase.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline cardiorespiratory status throughout each of the 25 sessions
大体时间：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
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Blood pressure, heart rate and peripheral oxygen saturation and will be used to identify any cardiovascular issues of orthostatic hypotension or autonomic dysreflexia.
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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
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Skin integrity
大体时间：At the beginning and end of each training session for 25 sessions, on average of 2 months
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A visual inspection of areas of significant weight bearing and skin/machine interface will take place at the beginning and end of each training session to monitor for skin breakdown or compromise.
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At the beginning and end of each training session for 25 sessions, on average of 2 months
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Falls
大体时间：From onset to cessation of each training session for 25 sessions, on average of 2 months
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Any incidence of falls will be recorded and the participant will be evaluated for injury by unit medical staff or on site emergency staff if warranted.
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From onset to cessation of each training session for 25 sessions, on average of 2 months
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Pain visual analogue scale
大体时间：At the beginning and end of each training session for 25 sessions, on average of 2 months
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Participants draw an intersecting line on a 10 cm line (scale) in order to rate their amount of subjective pain.
The distance on the 10 cm line is measured from the left side (no pain) and turned into a numerical value.
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At the beginning and end of each training session for 25 sessions, on average of 2 months
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Borg scale of perceived exertion
大体时间：At the beginning, mid point (30 min) and end (60 min) of each training session for 25 sessions, on average of 2 months
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Subjects are shown the Borg scale of perceived exertion and are asked to choose the number/descriptor that best aligns with their current level of exertion at 0, 30 and 60 minutes.
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At the beginning, mid point (30 min) and end (60 min) of each training session for 25 sessions, on average of 2 months
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10 meter walk test
大体时间：Training sessions 1, 13 and 25 out of the 25 total sessions, on average of 2 months
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Time in seconds it takes a subject to walk a distance of 10 meters.
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Training sessions 1, 13 and 25 out of the 25 total sessions, on average of 2 months
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6 minute walk test
大体时间：Training sessions 1, 13 and 25 of the 25 total sessions, on average of 2 months
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Total distance a participant is able to walk in 6 minutes will be measured.
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Training sessions 1, 13 and 25 of the 25 total sessions, on average of 2 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Chester Ho, MD、University of Calgary
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年6月1日
初级完成 (实际的)
2018年2月1日
研究完成 (实际的)
2018年2月1日
研究注册日期
首次提交
2016年4月20日
首先提交符合 QC 标准的
2017年5月4日
首次发布 (实际的)
2017年5月9日
研究记录更新
最后更新发布 (实际的)
2019年5月16日
上次提交的符合 QC 标准的更新
2019年5月14日
最后验证
2019年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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