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临床试验/NCT04130425
NCT04130425已完成不适用

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

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
30
试验地点
2
主要终点
Degree of Forarm Rotation With Thermoplastic Ulnar Based Muenster Orthosis, Delta-Cast Orthosis and Hely and Weber Fracture Brace MTC

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Degree of Forarm Rotation With Thermoplastic Ulnar Based Muenster Orthosis, Delta-Cast Orthosis and Hely and Weber Fracture Brace MTC

时间窗: 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.

次要结局

  • Orthotics and Prosthetics User's Survey (OPUS )(1 day)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephanie N. Kannas

Principal Investigator

Mayo Clinic

研究点 (2)

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