Completed

Protective Brace to Prevent Hand and Arm Injuries

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What is being tested

piezoelectric wrist brace

Device
Who is being recruted

Cumulative Trauma Disorders

+ Carpal Tunnel Syndrome
From 21 to 55 Years
+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Interventional
Study Start: November 2003

See protocol details

Summary

Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last updated: March 8, 2006
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2003Actual date on which the first participant was enrolled.

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. 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.

Official TitleShock Absorbing Brace for Study of Upper Extremity Musculoskeletal Disorders 
Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last updated: March 8, 2006
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
15 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 21 to 55 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cumulative Trauma Disorders
Carpal Tunnel Syndrome
Criteria
1 inclusion criteria required to participate
Normal hand anatomy and full range of motion
7 exclusion criteria prevent from participating
History of significant hand or wrist arthritis
Open wounds
Prior hand or wrist surgery
Neuropathies

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
UCLA Hand CenterLos Angeles, United StatesSee the location
CompletedOne Study Center