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临床试验/NCT04616378
NCT04616378已完成不适用

Design, Prototyping, and Testing of a Robotic Prosthetic Leg

Loma Linda University2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2
试验地点
2
主要终点
Timed up and go test

研究概览

简要总结

The purpose of this graduate student research study is to test that a specifically designed and novel robotic prosthetic leg (RPL) is feasible, safe and improves symmetry, efficiency, and metabolic function during sit-to-stand and stand-to-sit transitions as compared to the subject's prescribed device, and as compared to no device at all.

详细描述

Phase 2 case study

  • Two subjects will be fitted with a heart rate monitor and with an adapted waist belt with mobile phone attached.
  • RPL alignment will be verified.
  • The subjects will use the RPL in parallel bars 10 times and take rests as needed in a chair.
  • The subjects will perform the timed up and go test (TUGT), 10-meter walk test (10MWT), and the 6-minute walk test (6MWT).
  • The subjects will be fitted with retro-reflective markers.
  • The subjects will be fitted with a portable oxygen uptake analyzer.
  • A 4D motion-capture camera system will be used while performing TUGT and five times sit to stand (5XSTS).
  • The subjects will perform the above tests in their prescribed daily-wear prosthesis, and then in the RPL.
  • The subjects will complete the activities-based balance confidence (ABC) scale test.
  • The subjects will be asked a series of open-ended questions regarding the experience, while being audio recorded.

Phase 3 pilot study

  • Twenty subjects will be randomized into three treatment arms (no prosthesis, prescribed prosthesis, RPL).
  • The subject will be fitted with a heart rate monitor.
  • The subject will be fitted with a portable oxygen uptake analyzer.
  • The subject will be fitted with the RPL, and the alignment of the RPL will be confirmed before testing.
  • The subject will be fitted with retro-reflective markers.
  • A 4D motion-capture camera system and force-plate will be used while performing the 5XSTS test in the assigned randomized condition. The test will be performed three times in each condition.
  • The subject will return two more times to complete the tests in the remaining randomized conditions, with a two-week washout period between sessions.
  • The subject will be given the ABC scale test in the beginning and at the end of this study.
  • The subject will complete the technology attitudes questionnaire (TAQ).
  • In total, subject participation will last 1 hour per day, for three sessions, two weeks apart.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • unilateral limb-loss.
  • amputation or knee disarticulation/transfemoral amputation
  • can walk with a variable cadence (Level K3) or play sports (Level K4)
  • uses a prosthesis for walking daily
  • can stand for 30 seconds on one limb
  • can follow one-step commands.

排除标准

  • Those who can not walk with a variable cadence (Level K1 and K2)
  • compromised skin on the residual limb (stump)
  • uncontrolled swelling
  • missing more than one limb
  • Inclusion Criteria:
  • unilateral knee disarticulation or transfemoral amputation.
  • can walk at a single speed (Level K2), can walk with a variable cadence (Level K3) or play sports (Level K4)
  • can follow one step commands.
  • Exclusion Criteria:
  • Those who do not use prosthesis for walking (Level K1)
  • compromised skin on the residual limb (stump)
  • uncontrolled swelling
  • missing more than one limb

结局指标

主要结局

Timed up and go test

时间窗: two weeks

The participant sits in a standard armchair with any assistive device used for walking nearby. The participant stands and at a self-selected walking speed, walks 3 meters, turns, and walks back to the chair, and sits down. A stopwatch records the time to of the test (in seconds).

次要结局

  • 10 meter walk test(one week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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