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临床试验/NCT00972296
NCT00972296已完成不适用

Comparison of Two Types of Ankle Braces in the Management of Ankle Pain in Hemophilia

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Pain relief measured by lower pain score with either AFO or cast boot

研究概览

简要总结

This project proposes to examine the difference in effectiveness of fracture boots and carbon fiber braces in the management of gait abnormalities and pain relief due to ankle pain from arthritis due to ankle bleeds. Fracture boots are "walking casts" that you can put on and take off. They prevent the ankle from moving and have a curved sole to mimic normal walking. They can help relieve pain of ankle arthritis from ankle bleeds by stopping ankle motion and absorbing some of the body's own weight while walking. Carbon fiber braces use newer technology resulting in lighter and smaller braces. They are designed to assist with helping clear the toe and straighten the knee while walking.

Gait analysis wearing both the fracture boot and carbon fiber brace will be performed by walking on a mat equipped with pressure sensors and will examine the effect of the fracture boot and the carbon fiber brace on how you walk. These tests will be compared to walking on the mat without either brace. The sensors on the mat will measure different aspects of gait such as step length and foot position. You will be asked questions about how much ankle pain you have using no brace compared to each brace.

People with hemophilia A or B and ankle pain from bleeds will be asked to participate. They will be approached during routine clinic visits and will also be contacted by telephone.

Levels of pain will be measured before, during and after each trial using standardized visual analog and ordinal pain scales. Measurements from the gait mat and levels of pain relief will be used to determine effectiveness of each type of support.

Statisticians will be used to analyze results of the gait mat and pain scale measurements.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

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

入选标准

  • Hemophilia A or B, with or without inhibitor, with unilateral or bilateral ankle pain

排除标准

  • 未提供

结局指标

主要结局

Pain relief measured by lower pain score with either AFO or cast boot

时间窗: Outcome to be assessed at the time of trial

次要结局

  • Improvement of gait parameters(To be assessed at time of trial)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Oleson

Principal Investigator

Oregon Health and Science University

研究点 (1)

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