Evaluation of an Energy-Harvesting Knee Prosthesis in Transfemoral Prosthesis Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Time to Complete Sit-to-Stand
研究概览
简要总结
The purpose of this research is to validate the Assist-Knee design and function by collecting pilot data during the stand-to-sit-to-stand transition in transfemoral prosthesis users when using the Assist-Knee to harvest energy and return energy .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral transfemoral limb loss
- •At least one year post-amputation and currently successfully using a prosthesis
- •Uses modular endoskeletal prosthetic components
- •Has bilateral normal range of motion
- •Ability to perform the following activities:
- •Walking ability or ability to take steps over 10 meters
- •Upright standing stability
- •Stand-to-sit stability (i.e. go from a standing position to a seated position independently)
- •Sit-to-stand stability (i.e. rise from a seated position independently)
- •Ability to communicate individual perceptions in the English language
- •Ability to provide informed consent
排除标准
- •Confounding injury or musculoskeletal problem
- •Pregnancy
- •Lower limb peripheral neuropathy
- •Symptomatic cardiovascular disease or chronic obstructive pulmonary disease
- •Not able to read and understand English
- •Use of assistive devices for sit-to-stand and stand-to-sit (e.g. canes, walkers)
研究组 & 干预措施
Habitual Prosthesis
Participant's prescribed prosthesis
干预措施: Habitual Prosthesis (Device)
Assist-Knee
Experimental knee prosthesis
干预措施: Assist-Knee (Device)
结局指标
主要结局
Time to Complete Sit-to-Stand
时间窗: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least four trials of the sit-to-stand maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition were calculated for each participant (each participant served as their own control in this pilot study). The start of the transition was determined by participant initiation; the end of the transition was determined by the participant reaching full knee extension.
Time to Complete Sit-to-Stand
时间窗: Collection at baseline
The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least four trials of the sit-to-stand maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition were calculated for each participant (each participant served as their own control in this pilot study). The start of the transition was determined by participant initiation; the end of the transition was determined by the participant reaching full knee extension.
次要结局
- Timed Up and Go (TUG) Test(After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.))
- Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion(After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.))
- Time to Complete Stand-to-Sit(After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.))
- Timed Up and Go (TUG) Test(Collection at baseline)
- Time to Complete Stand-to-Sit(Collection at baseline)
- Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion(Collection at baseline)