A Clinical Trial Comparing Functional Performance of Voluntary Opening and Closing Body Powered Prosthetic Terminal Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Sternal Displacement During Towel Folding Task
研究概览
简要总结
This study will compare the functional performance of voluntary opening (VO) and voluntary closing (VC) body powered prostheses. We hypothesize that the ability to sense cable tension and produce progressively higher pinch from shoulder force will result in advantages for the VC terminal device (TRS, Grip 3) in terms of proprioception and overall function. The specific aims of this clinical trial are to:
- Determine if accommodation with a VC Grip 3 prehensor will result in reduced compensatory motion during activity.
- Determine if accommodation with a VC Grip 3 prehensor will result in improved function in activities of daily living.
详细描述
To evaluate the performance of the prehensors, subjects will complete a randomized A-B crossover study with a subjective follow-up. Two subject categories will be evaluated: 1.) healthy non-amputees, and 2.) unilateral transradial amputee subjects who currently use, or are interested in using a body-powered prosthesis. We anticipate data collection data with 10 non-amputee subject, and 8 amputee subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Unilateral transradial or wrist-disarticulation amputee
- •18 to 85 years of age
- •At least 1 year from date of amputation
- •Be able to independently provide informed consent
- •Be willing to comply with study procedures
排除标准
- •History of acute or chronic skin breakdown on the residual limb
- •Prosthetic socket adjustment within 90 days
- •Any condition that would prevent participation and pose increased risk (e.g. shoulder impingement, sub-acromial bursitis, severe arthritis of the shoulder, elbow, wrist, or fingers)
- •Injuries of the upper limb within the past 90 days (surgeries, sprains, strains, or fractures).
- •Unwillingness/inability to follow instructions Inclusion criteria for able-bodied subjects
- •18 to 85 years of age
- •Able to provide independent, informed consent
- •Independent function by self-report
- •Free of any health ailment that would impair physical function Exclusion criteria for able-bodied subjects
- •Younger than 18 or older than 85 years of age
- •Any condition that would prevent participation and pose increased risk (e.g. shoulder impingement, sub-acromial bursitis, severe arthritis of the shoulder, elbow, wrist, or fingers)
- •No injuries of the upper limb within the past 90 days (surgeries, sprains, strains, or fractures).
- •Unwillingness/inability to follow instructions
研究组 & 干预措施
Prosthetic hand 1 (Hosmer 5XA)
This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1
干预措施: Hosmer 5XA voluntary opening hook (Device)
Prosthetic hand 2 (TRS Grip 3)
This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2
干预措施: TRS Grip 3 voluntary closing hook (Device)
Non-amputee controls
This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
结局指标
主要结局
Sternal Displacement During Towel Folding Task
时间窗: Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.
Distance sternum is displaced while folding a towel was measured in meters.
Physical Function Performance 10 Test Score
时间窗: Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.
Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.
次要结局
未报告次要终点
研究者
Jason Highsmith
Assistant Professor
University of South Florida