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Functional Performance of Voluntary Opening and Closing Body Powered Prostheses

NCT ID: NCT02136238

Last Updated: 2023-12-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-11-30

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:

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

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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.

Conditions

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Upper Limb Amputation

Keywords

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amputation transradial prosthesis terminal device

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prosthetic hand 1 (Hosmer 5XA)

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

Group Type ACTIVE_COMPARATOR

Hosmer 5XA voluntary opening hook

Intervention Type DEVICE

Voluntary opening prosthetic terminal device ("hand")

Prosthetic hand 2 (TRS Grip 3)

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

Group Type ACTIVE_COMPARATOR

TRS Grip 3 voluntary closing hook

Intervention Type DEVICE

Voluntary closing prosthetic terminal device ("hand")

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hosmer 5XA voluntary opening hook

Voluntary opening prosthetic terminal device ("hand")

Intervention Type DEVICE

TRS Grip 3 voluntary closing hook

Voluntary closing prosthetic terminal device ("hand")

Intervention Type DEVICE

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
* 18 to 85 years of age
* Able to provide independent, informed consent
* Independent function by self-report

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).
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Florida High Tech Corridor Council

OTHER

Sponsor Role collaborator

TRS, Inc.

INDUSTRY

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Jason Highsmith

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason Highsmith, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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University of South Florida

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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Pro0013189

Identifier Type: -

Identifier Source: org_study_id