University of South Florida
Tampa, Florida, 33612, United States
NCT Number: NCT02136238
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:
1. Determine if accommodation with a VC Grip 3 prehensor will result in reduced compensatory motion during activity. 2. Determine if accommodation with a VC Grip 3 prehensor will result in improved function in activities of daily living.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Tampa, Florida, 33612, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Voluntary opening prosthetic terminal device ("hand")
Voluntary closing prosthetic terminal device ("hand")
Time frame: 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.
Time frame: 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.
University of South Florida
Other
A Clinical Trial Comparing Functional Performance of Voluntary Opening and Closing Body Powered Prosthetic Terminal Devices
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