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Completed

NCT Number: NCT02136238

Functional Performance of Voluntary Opening and Closing Body Powered Prostheses

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida

Tampa, Florida, 33612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hosmer 5XA voluntary opening hook

Device

Voluntary opening prosthetic terminal device ("hand")

TRS Grip 3 voluntary closing hook

Device

Voluntary closing prosthetic terminal device ("hand")

Primary outcomes

  1. Sternal Displacement During Towel Folding Task

    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.

  2. Physical Function Performance 10 Test Score

    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.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • Florida High Tech Corridor Council
  • TRS, Inc.

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 12, 2014
Registry last updated
Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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