跳至主要内容
临床试验/NCT05850325
NCT05850325Enrolling By Invitation不适用

Novel Exercises to Facilitate Recovery of Supination and Pronation for Distal Radius Fractures Managed With a Volar Plate

Indiana Hand to Shoulder Center2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
42
试验地点
2
主要终点
Range of Motion

研究概览

简要总结

The primary objective of this study is to evaluate the influence of elbow position on achieving forearm supination and pronation and wrist ROM postoperatively. It is anticipated the results will show recovery of functional motion in a shorter period of time (27 days average). As for the secondary objective of the study, it is anticipated there will be limited pain and cost-containment. These data elements will serve as secondary factors to evaluate.

详细描述

The current standard of care for forearm range of motion exercises is to position the elbow in 90 degrees of flexion at the side of the body for both supination and pronation.5,6 This study will compare standard of care forearm rotation exercises to exercising with the elbow in extension to facilitate pronation and exercising with the elbow in full flexion to facilitate supination in patients who have undergone surgery with a volar plate for distal radius fractures. We hypothesize that forearm motion will be achieved in a shorter number of days and with a greater arc of motion when the exercises are done in extremes of elbow flexion and extension.

This will be a prospective, unblinded, randomized study to evaluate forearm range of motion across two groups:

Control Group: subjects will be instructed to exercise the forearm with the elbow positioned by their side, in 90° of flexion.

Test Group: subjects will be instructed to exercise the forearm with their elbow fully flexed to achieve supination and the elbow extended to achieve pronation.

Randomization will occur post-operatively after the patient has signed consent to participate. Randomization will occur through a computerized random allocation and groups will be assigned by the Clinical Research Manager or designee.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • • Subjects 18 years of age and older
  • Subjects with distal radius fractures with a volar plate
  • Subjects attending therapy at the Indiana Hand to Shoulder Center or affiliated satellites.
  • Subjects that attend the initial therapy visit between 5 and 10 days postoperative and begin the home therapy program (patient handout)

排除标准

  • • Subjects under the age of 18
  • Additional surgical procedures or other factors preventing early active ROM of the forearm and/or wrist within the initial 10 days following surgery
  • Pre-existing medical conditions or injuries with resultant limitation in elbow, forearm or wrist ROM, patient-reported limited function, or limited ability to comply with home program (cognitive skills).
  • While undergoing therapy the initial 6 weeks, subjects provided with custom-fabricated or pre-fabricated devices, orthoses, or braces for the specific purpose of passively improving ROM of the elbow, forearm or wrist during the initial 6 weeks of therapy.

结局指标

主要结局

Range of Motion

时间窗: 6 Months

forearm supination and pronation and wrist ROm

次要结局

  • QuickDisability of the Arm Shoulder Hand (DASH)(6 Months)
  • Upper Limb Functional Index (ULFI)(6 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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