N/A
N=18
Functional Performance of Voluntary Opening and Closing Body Powered Prostheses
Upper Limb Amputation
Bottom Line
View on ClinicalTrials.gov: NCT02136238 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Sternal Displacement During Towel Folding Task — 1.0; 1.06; 0.88 meters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hosmer 5XA voluntary opening hook (Device); TRS Grip 3 voluntary closing hook (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of South Florida
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sternal Displacement During Towel Folding Task |
1.0; 1.06; 0.88 | — |
| PRIMARY Physical Function Performance 10 Test Score |
39.1; 37.0; 68.1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02136238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.