Functional Performance of Voluntary Opening and Closing Body Powered Prostheses

NCT02136238 | Completed Results DMC

• 1 other identifier: Pro0013189
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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. 1.Determine if accommodation with a VC Grip 3 prehensor will result in reduced compensatory motion during activity.
2. 2.Determine if accommodation with a VC Grip 3 prehensor will result in improved function in activities of daily living.

Conditions

Upper Limb Amputation

Keywords

amputation; transradial; prosthesis; terminal device

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (3)

Prosthetic hand 1 (Hosmer 5XA)

ACTIVE COMPARATOR

This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1

Device: Hosmer 5XA voluntary opening hook

Prosthetic hand 2 (TRS Grip 3)

ACTIVE COMPARATOR

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

Non-amputee controls

NO INTERVENTION

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.

Interventions

Hosmer 5XA voluntary opening hook DEVICE

Voluntary opening prosthetic terminal device ("hand")

Prosthetic hand 1 (Hosmer 5XA)

TRS Grip 3 voluntary closing hook DEVICE

Voluntary closing prosthetic terminal device ("hand")

Prosthetic hand 2 (TRS Grip 3)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral transradial or wrist-disarticulation amputee
• to 85 years of age
• At least 1 year from date of amputation
• Be able to independently provide informed consent

You may not qualify if:

• 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).
• to 85 years of age
• Able to provide independent, informed consent
• Independent function by self-report
• 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

Sponsors & Collaborators

• University of South Florida: lead
• Florida High Tech Corridor Council: collaborator
• TRS, Inc.: collaborator

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

Results Point of Contact

• Title: Jason Highsmith
• Organization: University of South Florida

mhighsmi@health.usf.edu

813-974-3806

Study Officials

• Jason Highsmith, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: May 12, 2014
• Study Start: September 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 28, 2023
• Results First Posted: April 29, 2015

Record last verified: 2023-12

Locations

US (1)