NCT00074893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2003

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2003

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

March 8, 2006

Status Verified

March 1, 2006

First QC Date

December 23, 2003

Last Update Submit

March 6, 2006

Conditions

Cumulative Trauma DisordersCarpal Tunnel Syndrome

Keywords

Repetitive Strain InjuriesVibration DampingProtective BracePiezoelectricSmartWear

Interventions

piezoelectric wrist braceDEVICE

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal hand anatomy and full range of motion

You may not qualify if:

  • History of significant hand or wrist arthritis
  • Open wounds
  • Prior hand or wrist surgery
  • Neuropathies
  • Skin hypersensitivity
  • Contact dermatitis
  • Reflex sympathetic dystrophy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Hand Center

Los Angeles, California, 90095-6902, United States

Location

MeSH Terms

Conditions

Cumulative Trauma DisordersCarpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Sprains and StrainsWounds and InjuriesMedian NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression Syndromes

Study Officials

  • Michael D. Pottenger, PhD

    SmartWear, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

December 23, 2003

First Posted

December 24, 2003

Study Start

November 1, 2003

Study Completion

February 1, 2004

Last Updated

March 8, 2006

Record last verified: 2006-03

Locations

US(1)