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临床试验/NCT03828214
NCT03828214已完成不适用

Post Stroke Walking Kinematics Using the Honda Walking Assist Robotic Exoskeleton

College of St. Scholastica, Inc.2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2018年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
2
主要终点
Gait Kinematics

研究概览

简要总结

To investigate the effect of a robotic exoskeleton on kinematics, muscle activity, ground reaction forces and spatiotemporal characteristics during walking in persons post stroke.

详细描述

Following stroke walking dysfunction is prevalent. Traditional rehabilitation methods fall short of achieving desirable walking outcomes for most people who experience stroke. Robotic methods to assist walking, such as the Honda Walking Assist Device (HWA) Robot from Honda R & D Americas Inc., are being explored as a means of improving the recovery of walking post stroke. Prior to examining the effectiveness of exoskeletal robots for walking recovery it is important to understand their effect on kinematic and muscle responses during walking. Kinematic and muscle responses at the hip during walking with the HWA were recently described.

The purpose of this study is to quantify the effect of walking with the HWA on body segments remote from the hip. These segments include knee, ankle, trunk and arm. The non-invasive measures used will include: walking kinematics (measurement of joint angles using cameras), muscle activity (Electromyography), ground reaction forces (detected by a force plate in the floor) and spatiotemporal characteristics (such as walking speed). Measures will be collected under three conditions: 1) walking at self-selected pace (control), 2) walking at self-selected pace with the HWA (4 Newton-meter assist mode for hip flexion and extension), 3) walking immediately following HWA use (aftereffect).

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥12 weeks but <1 year post stroke at time of study participation
  • Age: 18-85 years
  • Ability to walk a minimum of 10 meters with standby assistance with or without orthosis or assistive device (Functional Ambulation categories 3, 4 or 5)
  • Able to follow three step commands
  • Express the ability to understand study tasks and purpose
  • Able and willing to provide written informed consent
  • Living in the community with the ability to travel to maurices Community Clinic for testing
  • Willingness to wear the StepWatch pedometer for a period of 3 days in their home
  • (If applicable) ≥ 90 days post major orthopedic surgery (such as a joint replacement)
  • (If applicable) ≥ 6 months post cardiac surgery

排除标准

  • Serious cardiac conditions (hospitalized for myocardial infarction or heart surgery within 3 months, congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
  • Severe arthritis or orthopedic conditions that limit lower extremity range of motion (> 10° or < 90° knee flexion, lacking > 25° hip extension, >15° from neutral plantar flexion.)
  • Preexisting neurologic disorders such as Dementia, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Parkinson's Disease or Ataxia.
  • History of lower limb amputation, non-healing ulcers, legal blindness or severe visual impairment

结局指标

主要结局

Gait Kinematics

时间窗: Gait kinematics were measured in each of 4 conditions during one 2-hour session for each participant.

Difference in affected leg maximum knee flexion angle (initial swing to midswing) between conditions Kinematic Analysis of Gait will be obtained using a Qualisys 8-camera motion capture system. Sample rate 120 Hz. A modified Istituti Ortopedici Rizzoli (IOR) gait marker set (\~40 markers) applied bilaterally.

次要结局

  • Lower Limb Electromyography (EMG)(Measured during swing phase of gait during each of 4 walking conditions during a single data collection session.)
  • Ground Reaction Force at Terminal Stance(Force data will be measured at a single time point (in one 2-hour session) for each participant in each of 4 conditions.)
  • Stair Climbing Ascend/Descend Test(Stairs will be measured at a single time point (in one 2-hour session) for each participant)

研究者

发起方
College of St. Scholastica, Inc.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandra Borstad

Associate Professor

College of St. Scholastica, Inc.

研究点 (2)

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