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临床试验/NCT03530592
NCT03530592尚未招募不适用

Seated Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project

Baltimore VA Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
2
主要终点
Ankle dorsiflexion-plantarflexion range of motion

研究概览

简要总结

The purpose of this research study is to test the utility of an ankle robot in people with ankle weakness and foot drop from a peripheral nervous system injury due to neuromuscular or orthopedic injury.

详细描述

Many individuals with central nervous system (CNS) injuries (e.g., a stroke) or peripheral nervous system (PNS) injuries (e.g., peroneal nerve injury, neuropathy, radiculopathy, and/or musculoskeletal injury) that affect their ankle movement have residual impairments that affect their walking and balance. These impairments include the disability "foot drop," which increases the risk for falling.

This study will focus on PNS injuries that cause foot drop.

Current therapy to address foot drop is limited primarily to the use of ankle foot orthoses (braces) that help keep the foot from hitting the ground to prevent falling. Also, some individuals with foot drop use functional electrical stimulation to the leg nerve to lift the foot. Regardless, none of these, or other existing, methods to address foot drop cures or even improves significantly the underlying neurological deficit behind this disability. Braces improve walking safety only while they are worn, and functional electrical stimulation does not work when it is turned off, or when the nerve has been severely damaged. Thus, the increased fall risk due to foot drop is generally considered life-long and incurable.

The investigators have developed a shoe-interfaced ankle robot with an adaptive control system, to assist an individual with ankle movement only as needed. Data from the investigators' previous studies on foot drop due to stroke show great promise for this ankle robot as a new rehabilitation tool for invididuals with foot drop. The investigators would like to utilize our findings from these stroke studies in learning how they can be used for PNS-related foot drop.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women, aged 18 to 88 years
  • Chronic foot drop and ankle weakness in one leg from a peripheral nervous system injury due to a neuromuscular or orthopedic injury
  • Ability to walk 10 meters and arise from a chair with no human assistance (but usage of usual assistive device[s] is permitted)

排除标准

  • Medical history that would preclude participation in low-intensity seated robotic-assisted rehabilitation
  • Current participation in orthopedic or rehabilitation medical programs
  • Active deep venous thrombosis
  • Distal paretic leg skin lesions, infections, or soft tissue inflammation

研究组 & 干预措施

Seated Ankle Robot Training

Experimental

干预措施: Seated Ankle Robot Training (Device)

结局指标

主要结局

Ankle dorsiflexion-plantarflexion range of motion

时间窗: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

degrees

Ankle inversion-eversion range of motion

时间窗: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

degrees

Gait velocity during self-selected overground walking

时间窗: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

cm/sec

Postural sway areas during quiet standing

时间窗: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

cm\^2; extent of postural deviations to assess static postural control

Ratio of asymmetric loading in quiet standing

时间窗: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

ratio of Newtons of force per leg while standing quietly

Push-off forces during gait initiation

时间窗: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

Newtons; magnitude of forward ground reaction forces.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Charlene Elaine Hafer-Macko

Associate Professor of Neurology

Baltimore VA Medical Center

研究点 (2)

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