Functional Performance of Voluntary Opening and Closing Body Powered Prostheses

University of South Florida

Status: Completed

Conditions: Upper Limb Amputation

Treatments: Device: Hosmer 5XA voluntary opening hook; Device: TRS Grip 3 voluntary closing hook

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02136238

Pro0013189

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Prosthetic hand 1 (Hosmer 5XA)

Active Comparator group

Description:

This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1

Treatment:

Device: Hosmer 5XA voluntary opening hook

Prosthetic hand 2 (TRS Grip 3)

Active Comparator group

Description:

This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2

Treatment:

Device: TRS Grip 3 voluntary closing hook

Non-amputee controls

No Intervention group

Description:

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.