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

Study Overview
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Device: Hely & Weber MTC Fracture Brace
* Device: Thermoplastic orthosis
* Device: Delta cast orthosis


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Individuals<br>Subject will be measured for forearm rotation while wearing the custom orthoses Hely & Weber MTC Fracture Brace, thermoplastic orthosis, and delta cast orthosis. | Device: Hely & Weber MTC Fracture Brace<br>* Prefabricated muenster orthosis<br>Device: Thermoplastic orthosis<br>* Muenster orthosis fabricated out of thermoplastics and secured with Velcro<br>Device: Delta cast orthosis<br>* Muenster orthosis fabricated out of Delta Cast and secured with Velcro<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Forarm Rotation With Thermoplastic Ulnar Based Muenster Orthosis, Delta-Cast Orthosis and Hely and Weber Fracture Brace MTC | Degree of forarm rotation (supination/pronation) measured by an electronic goniometer device reported unit of measurement in degrees while wearing each of the orthoses. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orthotics and Prosthetics User's Survey (OPUS ) | The OPUS is a well validated, self-report questionnaire which consists of five modules; specifically, five questions from the OPUS: Satisfaction with Device and Services Module were used. These five questions were scored on a 5-point Likert scale from strongly agree to strongly disagree. A sixth option of don't know or not applicable was also available. Strongly agree = 5, Agree = 4, Neutral =3, Disagree =2, Strongly Disagree =1. If the participant chose don't know or not applicable that question was excluded for that participant. The five questions included- . My orthosis fits well. . The weight of my orthosis is manageable. . It is easy to put on my orthosis. . My orthosis is pain free to wear. . My orthosis looks good. The remaining 16 questions from the module were excluded, as they did not pertain to healthy volunteers wearing the orthosis only during his/her research participation. | 1 day |