Functional Performance of Voluntary Opening and Closing Body Powered Prostheses

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

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.

Study Overview

• Status: Completed
• Conditions: Upper Limb Amputation
• Intervention / Treatment: Device: Hosmer 5XA voluntary opening hook; Device: TRS Grip 3 voluntary closing hook

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • University of South Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Active Comparator: Prosthetic hand 1 (Hosmer 5XA); This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1	Device: Hosmer 5XA voluntary opening hook; Voluntary opening prosthetic terminal device ("hand")
Active Comparator: Prosthetic hand 2 (TRS Grip 3); This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2	Device: TRS Grip 3 voluntary closing hook; Voluntary closing prosthetic terminal device ("hand")

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: Florida High Tech Corridor Council; TRS, Inc.
• Investigators: Principal Investigator: Jason Highsmith, PhD, University of South Florida

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: February 17, 2014
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (Estimated): May 12, 2014

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: prosthesis; transradial; terminal device; amputation
• Other Study ID Numbers: Pro0013189