Protective Brace to Prevent Hand and Arm Injuries
Primary Purpose
Cumulative Trauma Disorders, Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
piezoelectric wrist brace
Sponsored by
About this trial
This is an interventional prevention trial for Cumulative Trauma Disorders focused on measuring Repetitive Strain Injuries, Vibration Damping, Protective Brace, Piezoelectric, SmartWear
Eligibility Criteria
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
Sites / Locations
- UCLA Hand Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00074893
First Posted
December 23, 2003
Last Updated
March 6, 2006
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT00074893
Brief Title
Protective Brace to Prevent Hand and Arm Injuries
Official Title
Shock Absorbing Brace for Study of Upper Extremity Musculoskeletal Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cumulative Trauma Disorders, Carpal Tunnel Syndrome
Keywords
Repetitive Strain Injuries, Vibration Damping, Protective Brace, Piezoelectric, SmartWear
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
15 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
piezoelectric wrist brace
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D. Pottenger, PhD
Organizational Affiliation
SmartWear, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Hand Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6902
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Protective Brace to Prevent Hand and Arm Injuries
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