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Protective Brace to Prevent Hand and Arm Injuries

This study has been completed.

Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00074893
  Purpose

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.


Condition Intervention
Cumulative Trauma Disorders
Carpal Tunnel Syndrome
Device: piezoelectric wrist brace

Genetics Home Reference related topics:   Charcot-Marie-Tooth disease    hereditary neuropathy with liability to pressure palsies   

MedlinePlus related topics:   Arm Injuries and Disorders    Carpal Tunnel Syndrome    Injuries    Wounds   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Non-Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title:   Shock Absorbing Brace for Study of Upper Extremity Musculoskeletal Disorders

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Estimated Enrollment:   15
Study Start Date:   November 2003
Estimated Study Completion Date:   February 2004

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.

  Eligibility
Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074893

Locations
United States, California
UCLA Hand Center    
      Los Angeles, California, United States, 90095-6902

Sponsors and Collaborators

Investigators
Principal Investigator:     Michael D. Pottenger, PhD     SmartWear, LLC    
  More Information


Study ID Numbers:   NIAMS-079, 1R43AR49167-01
First Received:   December 23, 2003
Last Updated:   March 6, 2006
ClinicalTrials.gov Identifier:   NCT00074893
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Repetitive Strain Injuries  
Vibration Damping  
Protective Brace  
Piezoelectric  
SmartWear  

Study placed in the following topic categories:
Carpal Tunnel Syndrome
Roussy Levy hereditary areflexic dystasia
Charcot-Marie-Tooth Disease
Wounds and Injuries
Disorders of Environmental Origin
Mononeuropathies
Arm Injuries
Nerve Compression Syndromes
Tomaculous neuropathy
Shock
Musculoskeletal Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Hereditary Motor and Sensory Neuropathies
Charcot Marie Tooth disease
Cumulative Trauma Disorders
Sprains and Strains

Additional relevant MeSH terms:
Median Neuropathy
Pathologic Processes
Disease
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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