Functional Performance of Voluntary Opening and Closing Body Powered Prostheses

Upper Limb Amputation Clinical Trial

Official title:

A Clinical Trial Comparing Functional Performance of Voluntary Opening and Closing Body Powered Prosthetic Terminal Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136238
• Other study ID #: Pro0013189
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: November 2014

Study information

• Verified date: December 2023
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion criteria

• 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 Exclusion criteria
• 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

Related Conditions & MeSH terms

• Upper Limb Amputation

Intervention

Device:
• Hosmer 5XA voluntary opening hook
Voluntary opening prosthetic terminal device ("hand")
• TRS Grip 3 voluntary closing hook
Voluntary closing prosthetic terminal device ("hand")

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of South Florida	Florida High Tech Corridor Council, TRS, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sternal Displacement During Towel Folding Task	Distance sternum is displaced while folding a towel was measured in meters.	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.
Primary	Physical Function Performance 10 Test Score	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.	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.