临床试验/NCT02334618

NCT02334618已完成不适用

Clinical Trial of an Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of Ankle Fractures

University of Utah1 个研究点分布在 1 个国家目标入组 38 人开始时间: 2014年8月最近更新: 2017年10月26日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Utah
入组人数: 38
试验地点: 1
主要终点: Patient Activity Measure (PAM-13) Questionnaire

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to use a novel load monitoring technology to correlate limb loading to ankle fracture outcomes. This study will collect continuous limb loading data and will provide the first objective insight into how limb loading directs fracture healing.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 90 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patient is 18 years of age or older
•Patient has an ankle fracture
•Patient speaks English
•Patient weighs between 100 and 250 pounds
•Patient lives in close enough proximity to the hospital to return for all appointments (~100 miles)

排除标准

•Patient is younger than 18 years of age
•Patient has multiple fractures that would alter weight bearing protocol
•Patient does not speak English
•Patient weighs less than 100 pounds or more than 250 pounds
•Patient does not live in close enough proximity to the hospital to return for all appointments (~>100 miles)
•Patient has a traumatic brain injury that would make it so they cannot consent
•Patient has diabetes

结局指标

主要结局

Patient Activity Measure (PAM-13) Questionnaire

时间窗: Follow Up Visits up to 1-Year

A subjective evaluation of perceived compliance with physician instructions

次要结局

X-ray (AP and Lateral)(Follow Up Visits up to 1-Year)

研究者

发起方

University of Utah

申办方类型

Other

责任方

Principal Investigator

主要研究者

David Rothberg

M.D.

University of Utah

研究点 (1)

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