Design, Prototyping, and Testing of a Robotic Prosthetic Leg
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 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
- 是
入选标准
- •Inclusion Criteria:
- •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
研究组 & 干预措施
Phase 2 Prescribed Prosthesis
Participants everyday use of prosthesis
干预措施: Phase 2 Prescribed Prosthesis (Other)
Phase 2 Robotic Prosthetic Leg
Robotic prosthetic leg with powered knee and passive ankle
干预措施: Phase 2 Robotic Prosthetic Leg (Other)
Phase 3 Prescribed Prosthesis
Participants everyday use of prosthesis
干预措施: Phase 3 Prescribed Prosthesis (Other)
Phase 3 Robotic Prosthetic Leg
Robotic prosthetic leg with powered knee and passive ankle
干预措施: Phase 3 Robotic Prosthetic Leg (Other)
Phase 3 No Prosthesis
Participant performs tasks with no prosthetic device attached
干预措施: Phase 3 No Prosthesis (Other)
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)