Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Functional Performance of Voluntary Opening and Closing Body Powered Prostheses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02136238
Recruitment Status : Completed
First Posted : May 12, 2014
Results First Posted : April 29, 2015
Last Update Posted : April 29, 2015
Sponsor:
Collaborators:
Florida High Tech Corridor Council
TRS, Inc.
Information provided by (Responsible Party):
Jason Highsmith, University of South Florida

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Upper Limb Amputation Device: Hosmer 5XA voluntary opening hook Device: TRS Grip 3 voluntary closing hook Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial Comparing Functional Performance of Voluntary Opening and Closing Body Powered Prosthetic Terminal Devices
Study Start Date : September 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : November 2014
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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")
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02136238


Locations
Layout table for location information
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
Florida High Tech Corridor Council
TRS, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Jason Highsmith, PhD University of South Florida
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jason Highsmith, Assistant Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT02136238    
Other Study ID Numbers: Pro0013189
First Posted: May 12, 2014    Key Record Dates
Results First Posted: April 29, 2015
Last Update Posted: April 29, 2015
Last Verified: April 2015
Keywords provided by Jason Highsmith, University of South Florida:
amputation
transradial
prosthesis
terminal device