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

Not Applicable

Completed

Conditions: Healthy

Interventions: Device: Hely & Weber MTC Fracture Brace
Device: Thermoplastic orthosis
Device: Delta cast orthosis

Registration Number: NCT04130425

Lead Sponsor: Mayo Clinic

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Individuals	Delta cast orthosis	Subject will be measured for forearm rotation while wearing the custom orthoses Hely \& Weber MTC Fracture Brace, thermoplastic orthosis, and delta cast orthosis.
Healthy Individuals	Thermoplastic orthosis	Subject will be measured for forearm rotation while wearing the custom orthoses Hely \& Weber MTC Fracture Brace, thermoplastic orthosis, and delta cast orthosis.
Healthy Individuals	Hely & Weber MTC Fracture Brace	Subject will be measured for forearm rotation while wearing the custom orthoses Hely \& Weber MTC Fracture Brace, thermoplastic orthosis, and delta cast orthosis.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Orthotics and Prosthetics User's Survey (OPUS )	1 day	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- 1. . My orthosis fits well. 2. . The weight of my orthosis is manageable. 3. . It is easy to put on my orthosis. 4. . My orthosis is pain free to wear. 5. . 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.