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A Comparison Study of Three Standard Elbow Wrist Hand Orthoses to Limit Forearm Rotation

NCT ID: NCT04130425

Last Updated: 2020-12-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-06

Study Completion Date

2020-01-31

Brief Summary

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The Researchers are trying to assess which splint limits forearm rotation the best. These splints are commonly used in hand therapy to limit forearm rotation. This data will help hand surgery and hand therapy provide better outcomes.

Detailed Description

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Common upper extremity injuries often need to heal with no wrist and forearm range of motion. Forearm range of motion includes supination and pronation. Injuries that necessitate limiting forearm range of motion include fracture patterns involving the distal radioulnar joint (DRUJ), proximal radioulnar joint (PRUJ), triangular fibrocartilage complex (TFCC), both bone forearm fractures, ulnar shortening procedures, radial and ulnar osteotomies, DRUJ instability. Long arm orthoses, sugar tong orthoses and muenster style orthoses can all limit forearm rotation.

Past research has indicated common methods of immobilization to include the following: sugar tongs cast/orthosis, muenster cast/orthosis, long arm cast/orthosis/or short arm cast/orthosis, and an antirotation orthosis.

Currently, there are no research studies that compare the amount of forearm rotation in a traditional thermoplastic orthoses to newer materials such as a Delta Cast orthosis, or prefabricated muenster orthoses such as the Hely and Weber MTC Fracture Brace. The purpose of this study is to assess which orthosis-a traditional thermoplastic ulnar based muenster, a delta cast style muenster and the Hely and Weber MTC Fracture Brace-allows for the least amount of supination and pronation in a healthy population in the dominant extremity.

The researchers will assess the 3 different orthoses using a standard measuring device for pronation and supination. The participants will also be asked questions regarding comfort, fit, and style of each orthosis. 30 Participants data will be collected during the study.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy Individuals

Subject will be measured for forearm rotation while wearing the custom orthoses Hely \& Weber MTC Fracture Brace, thermoplastic orthosis, and delta cast orthosis.

Group Type EXPERIMENTAL

Hely & Weber MTC Fracture Brace

Intervention Type DEVICE

Prefabricated muenster orthosis

Thermoplastic orthosis

Intervention Type DEVICE

Muenster orthosis fabricated out of thermoplastics and secured with Velcro

Delta cast orthosis

Intervention Type DEVICE

Muenster orthosis fabricated out of Delta Cast and secured with Velcro

Interventions

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Hely & Weber MTC Fracture Brace

Prefabricated muenster orthosis

Intervention Type DEVICE

Thermoplastic orthosis

Muenster orthosis fabricated out of thermoplastics and secured with Velcro

Intervention Type DEVICE

Delta cast orthosis

Muenster orthosis fabricated out of Delta Cast and secured with Velcro

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* No prior wrist or elbow injuries on the dominant side of his/her body
* Ability to complete study in one sitting of 90-120 minutes
* Between the ages of 18 years and 100 years
* Ability to follow directions and speak and read English

Exclusion Criteria

* Prior wrist or elbow injuries on the dominant side of his/her body
* Subjects with known rheumatoid arthritis deformities of the wrist or any prior wrist surgeries are excluded
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Stephanie N. Kannas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stepanie Kannas, CHT, OT, OTD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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18-008562

Identifier Type: -

Identifier Source: org_study_id