临床试验/NCT03891017

NCT03891017已完成不适用

Qualitative & Quantitative Comparison of Hydrostatic vs Vacuum Casting Methods in Trans-Tibial Amputees

Loma Linda University2 个研究点分布在 1 个国家目标入组 7 人开始时间: 2019年4月1日最近更新: 2019年7月15日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Loma Linda University
入组人数: 7
试验地点: 2
主要终点: Six-Minute Walk Test

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 graduate research study is to compare hydrostatic and vacuum casting techniques using patient mobility indicators, volume displacement, comfort, and overall satisfaction outcomes in trans-tibial amputees.

详细描述

Visit 1

Informed Consent
Subject will be casted using both the hydrostatic and vacuum system techniques

Visit 2 (7-10 days after Visit 1)

One of two sockets will be randomly assigned and fitted/aligned by investigators
Subject will be asked to perform a Timed Up and Go Test followed by a Six-Minute Walk Test
Subject will fill out a comfort questionnaire for the prosthesis worn

Visit 3 (7 to 10 days after Visit 2)

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
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: 是

入选标准

未提供

排除标准

未提供

结局指标

主要结局

Six-Minute Walk Test

时间窗: between 7-10- days after study enrollment

Participants will walk in a 100-ft hallway on a flat, hard surface in a period of 6 minutes.

次要结局

Six-Minute Walk Test(between 14-20 days after study enrollment)
Volume Calculation(between 14-20 days after study enrollment)

研究者

发起方

Loma Linda University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Heather Appling

Assistant Professor

Loma Linda University

研究点 (2)

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