Protective Brace to Prevent Hand and Arm Injuries

NCT ID: NCT00074893

Last Updated: 2006-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2004-02-29

Brief Summary

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When people use hand-held power tools, their hands and arms vibrate along with the tool they are holding. People who frequently use hand-held power tools may develop injuries related to this vibration. This study will evaluate a protective brace designed to prevent vibration-related hand and arms injuries.

Detailed Description

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Workers who use hand-held power tools absorb significant vibration energy in their arms and hands and may develop musculoskeletal disorders (MSDs) such as carpal tunnel syndrome and hand-arm vibration syndrome. Protective braces may be worn to decrease the incidence of occupational MSDs. The National Institute for Occupational Safety and Health has identified key attributes for protective braces; these attributes include vibration damping, comfort, non-interference with worker dexterity, and maintenance of safe hand temperature. Most currently available braces do not adequately address these NIOSH requirements. This study will evaluate the efficacy of a brace with piezoelectric damping material.

Participants in the study will be fitted with a brace on each hand. One brace will have piezoelectric damping material and the other will be a currently available, off-the-shelf commercial brace. Hand-held joysticks and handles mounted to a vibration shaker table will be used to simulate power tool use. Participants will undergo a series of tests designed to measure hand acceleration and vibration while grasping the study joysticks and handles. The tests will take approximately 30 minutes.

Conditions

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Cumulative Trauma Disorders Carpal Tunnel Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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piezoelectric wrist brace

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Normal hand anatomy and full range of motion

Exclusion Criteria

* History of significant hand or wrist arthritis
* Open wounds
* Prior hand or wrist surgery
* Neuropathies
* Skin hypersensitivity
* Contact dermatitis
* Reflex sympathetic dystrophy
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role lead

Principal Investigators

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Michael D. Pottenger, PhD

Role: PRINCIPAL_INVESTIGATOR

SmartWear, LLC

Locations

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UCLA Hand Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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1R43AR049167-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAMS-079

Identifier Type: -

Identifier Source: org_study_id