Clinical trial NCT02136238: Functional Performance of Voluntary Opening and Closing Body Powered Prostheses
Official title: A Clinical Trial Comparing Functional Performance of Voluntary Opening and Closing Body Powered Prosthetic Terminal Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Limb Amputation
Keywords: amputation
transradial
prosthesis
terminal device
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Florida High Tech Corridor Council
name: TRS, Inc.
First posted: 2014-05-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Sternal Displacement During Towel Folding Task
timeFrame: 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.
measure: Physical Function Performance 10 Test Score
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Jason Highsmith, PhD
role: PRINCIPAL_INVESTIGATOR
References: