Functional Performance of Voluntary Opening and Closing Body Powered Prostheses

Not Applicable

Completed

• Conditions: Upper Limb Amputation
• Interventions: Device: Hosmer 5XA voluntary opening hook; Device: TRS Grip 3 voluntary closing hook

• Registration Number: NCT02136238
• Lead Sponsor: University of South Florida

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-02-17
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-12
• Primary Completion: 2014-08
• Study Completion: 2014-11
• Results First Submitted: 2014-11-18
• Results First Submitted QC: 2015-04-10
• Results First Posted: 2015-04-29
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Prosthetic hand 1 (Hosmer 5XA)	Hosmer 5XA voluntary opening hook	This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1
Prosthetic hand 2 (TRS Grip 3)	TRS Grip 3 voluntary closing hook	This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2

Primary Outcome Measures

Name	Time	Method
Sternal Displacement During Towel Folding Task	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	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.

Trial Locations

Locations (1)

University of South Florida; 🇺🇸 Tampa, Florida, United States