A Prospective Study to Evaluate Use of the Tibion Bionic Leg in Sub-Acute Post-stroke Patients (Acute Effects)
2012年7月5日 更新者:Tibion Bionics, Inc.
A Prospective, Experimental ABA Study to Evaluate Use of the Tibion Bionic Leg in Subacute Post-stroke Patients Undergoing Physical Therapy
The objective of this clinical study is to examine acute changes in stability, force allocation, work, and mobility from using a wearable, portable, battery-operated robotic orthosis (the Tibion Bionic Leg) in subacute post-stroke persons undergoing lower extremity physical therapy.
研究概览
详细说明
Samples text.
研究类型
介入性
注册 (实际的)
10
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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Pennsylvania
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Philadelphia、Pennsylvania、美国、19102
- Magee Rehabilitation Hospital
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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
40年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Single stroke with residual unilateral lower-extremity weakness
- Subacute post-stroke period (>3 and <12 months)
- Eligible to participate to lower extremity physical therapy
- Age 40 years or greater
- Able to ambulate at least 10 meters
- Able to ambulate without a leg brace
- Ambulation speed less than 0.8 meters/second
- Minimum to moderate assist for transfer or ambulation by physical therapist evaluation
- Subject must understand the nature of the study and provide written informed consent prior to enrollment.
- Subject must be willing and able to attend all study sessions
Exclusion Criteria:
- Medically unstable
- Age younger than 40 years
- Acute post-stroke (< 3 months)
- Chronic post-stroke (> 12 months)
- Status-post multiple strokes
- Status-post traumatic brain injury
- Ambulation speed greater than 0.8 meters/second
- Currently using a Knee-Ankle-Foot Orthosis (KAFO)
- Not eligible for lower extremity physical therapy
- Concomitant degenerative neurological conditions
- Not able to ambulate at least 10 meters without assistance
- Greater than moderate assist during transfer or ambulation by physical therapist evaluation
- Unable to ambulate without a leg brace
- Unable to follow instructions, complete follow-up, or provide informed consent.
- Currently enrolled in another investigational device or drug trial
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:治疗
- 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:Tibion Arm
Arm of the study in which enrolled subacute post-stroke subjects undergo lower extremity physical therapy using the Tibion Bionic Leg.
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The Tibion Bionic Leg is used as an adjunct in post-stroke and post-operative rehabilitative physical therapy.
The leg is a lightweight, wearable, portable, battery-powered, motorized leg orthosis that provides active assistance and resistance to lower limb movement during walking, stair ascent and descent, and transfers from sitting to standing (and standing to sitting).
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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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Ambulation Speed
大体时间:Baseline (prior to training); at conclusion of training regimen, an average of 2 weeks.
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Walking speed (comfortable and fastest possible), in meters per second, as measured by the 10 Meter Walk Test (10 MWT).
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Baseline (prior to training); at conclusion of training regimen, an average of 2 weeks.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Measurements of Gait
大体时间:Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.
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The secondary endpoints are obtained from the GAITRite analysis system:
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Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.
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Measurements of Stride
大体时间:Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.
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Other secondary endpoints are obtained from the GAITRite analysis system:
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Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.
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Measurements of Force, Stance, and Stability
大体时间:Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.
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Other secondary endpoints are obtained from Balance Master system:
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Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.
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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:Barbara Browne, MD、Magee Rehabilitation Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Wong CK, Bishop L, Stein J. A wearable robotic knee orthosis for gait training: a case-series of hemiparetic stroke survivors. Prosthet Orthot Int. 2012 Mar;36(1):113-20. doi: 10.1177/0309364611428235. Epub 2011 Nov 14.
- Horst RW. A bio-robotic leg orthosis for rehabilitation and mobility enhancement. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:5030-3. doi: 10.1109/IEMBS.2009.5333581.
- Horst RW, Marcus RR. FlexCVA: a continuously variable actuator for active orthotics. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:2425-8. doi: 10.1109/IEMBS.2006.259950.
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
2012年3月1日
初级完成 (预期的)
2012年8月1日
研究完成 (预期的)
2012年8月1日
研究注册日期
首次提交
2012年3月6日
首先提交符合 QC 标准的
2012年3月16日
首次发布 (估计)
2012年3月20日
研究记录更新
最后更新发布 (估计)
2012年7月9日
上次提交的符合 QC 标准的更新
2012年7月5日
最后验证
2012年7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.
Tibion Bionic Leg的临床试验
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Otto Bock France SNC完全的
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Otto Bock Healthcare Products GmbHHanger Clinic: Prosthetics & Orthotics主动,不招人
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Massachusetts Institute of TechnologyHanger Clinic: Prosthetics & Orthotics招聘中