Functional Performance of Voluntary Opening and Closing Body Powered Prostheses

Study Overview
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Brief Summary
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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: Determine if accommodation with a VC Grip 3 prehensor will result in reduced compensatory motion during activity. Determine if accommodation with a VC Grip 3 prehensor will result in improved function in activities of daily living.

Detailed Description
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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.

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

Conditions
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Upper Limb Amputation

Intervention / Treatment
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* Device: Hosmer 5XA voluntary opening hook
* Device: TRS Grip 3 voluntary closing hook


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prosthetic hand 1 (Hosmer 5XA)<br>This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1 | Device: Hosmer 5XA voluntary opening hook<br>* Voluntary opening prosthetic terminal device (hand)<br>|
| Active Comparator: Prosthetic hand 2 (TRS Grip 3)<br>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<br>* Voluntary closing prosthetic terminal device (hand)<br>|
| No Intervention: Non-amputee controls<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amputation, transradial, prosthesis, terminal device