Evaluation of Transfer Kinematics and Kinetics in Patients Chronic Post-stroke Using the Tibion Bionic Leg
2012年11月13日 更新者：Tibion Bionics, Inc.
A Prospective, Experimental Study to Evaluate Transfer Kinematics and Kinetics of Chronic Post-stroke Patients With Tibion Bionic Leg
The objective of this clinical study is to examine the acute kinematics and kinetics of utilizing the Tibion Bionic Leg in a sample of chronic post-stroke patients performing sit-to-stand and stand-to-sit transfers across a range of assistance and resistance settings (internal to the device); to compare these metrics to baseline performance without the Bionic Leg; and to determine the Bionic Leg settings that optimize a restorative (equal force distribution) movement state in these patients.
研究概览
详细说明
Comprehensive motion (kinetics and kinematics) data specific to sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg. The Vicon Motion Analysis System will be utilized to track movement using markers on the subject and the Bionic Leg per the UCSF Human Performance Center's routine. Once outfitted with the marker system, patients will be instructed to perform multiple sit-to-stand and stand-to-sit transfers while data is gathered.
The sit-to-stand and stand-to-sit transfers will be performed using a standard chair, with a seat height not less than 12" from the floor. The chair will be positioned such that, at sitting rest, each of the subject's feet are positioned on limb-specific force plates (left and right).
研究类型
介入性
注册 (实际的)
20
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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California
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San Francisco、California、美国、94158
- UCSF Human Performance Center
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Sunnyvale、California、美国、94085
- Tibion Corporation
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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
30年 及以上 (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:
- Single ischemic stroke with residual unilateral lower-extremity weakness
- Chronic post-stroke (>12 months since event)
- Eligible to participate to lower extremity physical therapy
- Age 30 years or greater
- Able to ambulate at least 10 meters without therapist assistance
- Able to ambulate without a leg brace
- Able to transfer from sitting to standing without physical assistance from a therapist
- Able to transfer from standing to sitting without physical assistance from a therapist
- 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 30 years
- Subacute post-stroke (< 12 months since event)
- Status-post multiple strokes
- Status-post traumatic brain injury
- Not eligible to participate in lower extremity physical therapy
- Concomitant degenerative neurological conditions
- Not able to ambulate at least 10 meters without therapist assistance
- Unable to ambulate without a leg brace
- Unable to transfer from sitting to standing without physical assistance from a therapist
- Unable to transfer from standing to sitting without physical assistance from a therapist
- 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
- 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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无干预：Patient Population
Chronic post-stroke subjects with varied impairment level, who have completed routine rehabilitative physical therapy.
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The device is a lightweight, wearable, portable, battery-powered, robotic leg orthosis that provides active assistance and resistance to lower limb movement according to the patient's intent to move.
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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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Force
大体时间：Subject participation in the study is up to one (1) week.
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Force, in Newtons (N), by limb, as measured by kinematic and kinetic analysis during sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg.
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Subject participation in the study is up to one (1) week.
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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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Work
大体时间：Subject participation in study is up to one (1) week.
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Work, in Joules (J), by limb, as measured by kinematic and kinetic analysis during sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg.
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Subject participation in study is up to one (1) week.
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Torque
大体时间：Subject participation is up to one (1) week
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Torque, in Newton-meters (N-m), at the ankle and knee, by limb, as measured by kinematic and kinetic analysis during sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg.
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Subject participation is up to one (1) week
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Moment
大体时间：Subject participation is up to one (1) week
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Moment at the ankle and knee in Newtons (N), by limb, as measured by kinematic and kinetic analysis during sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg.
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Subject participation is up to one (1) week
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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：Joshua G Vose, MD、Tibion Corporation
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5月1日
初级完成 (实际的)
2012年11月1日
研究完成 (实际的)
2012年11月1日
研究注册日期
首次提交
2012年6月18日
首先提交符合 QC 标准的
2012年6月21日
首次发布 (估计)
2012年6月22日
研究记录更新
最后更新发布 (估计)
2012年11月14日
上次提交的符合 QC 标准的更新
2012年11月13日
最后验证
2012年11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.