Assistive ExoSkeletons to Enable Wearable Rehabilitation Robotics
Assistive ExoSkeleton & ExoTendon Platform to Enable Wearable Rehabilitation Robotics
研究概览
详细说明
Study will evaluate the use of lower-limb assistive exo-skeletons worn on the ankle and foot. Participants will include those with self-described history of Diabetic Foot Ulcer and age-matched healthy volunteers. Participants will wear the exo-skeletons and will be asked to walk 32 feet, and to stand quietly for 30 seconds.
Measurements will be taken to evaluate how the exoskeletons affect how people walk, and will also evaluate the pressure on the bottom of their feet. These measurements will be repeated multiple times to evaluate four different exo-tendon spring rates, and two sets of control shoes.
Exo-skeletons have been shown to reduce the pressure on the bottoms of people's feet and to reduce the effort to walk. This study is necessary to understand the contribution of different levels of exo-skeleton spring force to these effects.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Los Angeles、California、美国、90242
- Rancho Los Amigos
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Connecticut
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New Haven、Connecticut、美国、06515
- Southern CT State University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Self-reported history of diabetic foot ulcer
Exclusion Criteria:
- Unable to continuously ambulate/walk ≥ 40 feet without an assistive device, such as a cane or walker
- Signs/symptoms of an infected foot lesion/ulcer as determined by a basic foot exam
- Trans-metatarsal foot amputation or more significant amputation.
- Symptomatic for signs/symptoms of cardiovascular disease as determined from interpretation of the 2017 PAR-Q+ (predicated on participant responses of "yes" indicating symptomatic/unstable medical conditions to page 2 and page 3 of the 2017 PAR-Q)
- Participants will be excluded from this study if they demonstrate pre-participation, or chronic, signs/symptoms of hypoglycemia: Confusion, unusual headache, unusual visual disturbances, self-reported mental dullness, shakiness, self-reported weakness, abnormal sweating, undue nervousness/anxiety, and/or tingling of the mouth, toes, and/or fingers or if they answer yes to question 5b and 5c of the 2017 PAR-Q+ .
- Participants will be temporarily excluded from this study if they are symptomatic for acute illness such as cold or fever. If the participant is symptomatic for acute illness such as cold or fever, participation will be reconsidered upon illness resolution.
- If participants answer yes to question 4a of the 2017 PAR-Q+ and if they demonstrate pre-study participation resting blood pressure < 90/60 mmHg and >140/90 mmHg .
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 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:Primary Arm
Participants will be used as their own controls.
Participants will be evaluated using exo-skeletons with non-motorized spring elements in parallel to the Achilles tendon.
Up to 5 different levels of spring force will be evaluated to evaluate the impact upon plantar pressure and measures of fall risk.
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Ankle-foot exoskeleton - device to help reduce load on the bottom of the front of the foot
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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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Forefoot plantar pressure
大体时间:30 minutes
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Measurements of the force and pressure on the bottom of the front of the foot
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30 minutes
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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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Measures of fall risk
大体时间:30 minutes
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Measurements of postural sway, balance and gait speed to provide an indication of participant's risk of falling while wearing different shoes.
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30 minutes
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.
Exoskeleton的临床试验
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Wearable Robotics srl.Fondazione Don Carlo Gnocchi Onlus招聘中
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Wearable Robotics srl.Azienda Ospedaliero, Universitaria Pisana; University Hospital, Geneva; Ecole Polytechnique Fédérale...终止