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临床试验/NCT02712710
NCT02712710已完成不适用

Does Addition of a Functional Knee Brace Improve Rehabilitation Outcome in Subjects With Osteoarthritis of the Knee?

Shin Kong Wu Ho-Su Memorial Hospital1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2014年10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
41
试验地点
1
主要终点
VAS pain score

研究概览

简要总结

The purpose of this study is to investigate the effect of functional knee brace in the subjects with medial compartment knee OA.

详细描述

20 subjects with symptomatic medial compartment knee OA, with grade 2 to 4 on Kellgren and Lawrence scale, and showing willing to wear a functional knee brace will be recruited into this study. Another 20 subjects with comparable body height, weight, and sex will be served as a control group. All of the subjects received 4 weeks' rehabilitation treatment (3 times a week). VAS pain score, WOMAC index, and SF-36 will be evaluated before the treatment, and 1 month, and 3 months after the start of treatment. Patients' satisfaction will be evaluated at 1 month, and 3 months after start of treatment. Patients' compliance and any adverse events due to wearing of the functional knee brace will also be reported. A 2-by-3, 2-way mixed-model analysis of variance, which had 1 between-subject factor (group: knee brace + PT and PT only) and 1 within subject factor (evaluation time:T0, T1, T2) , was performed. Pair-wise comparisons between groups were performed using an independent t test (if in normal distribution) or Mann-Whitney U test (if not in normal distribution). Investigators hypothesize that addition of a functional knee brace would improve rehabilitation outcome in subjects with knee OA.

研究设计

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

入排标准

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

入选标准

  • According to the American College of Rheumatology (American College of Rheumatology) diagnosis of unilateral medial knee osteoarthritis, according to Kellgren and Lawrence X-rays are classified as two to four acceptable month rehabilitation therapy, and for the first time dressed Thruster Legacy's functional knee brace. The control group of patients with knee osteoarthritis same conditions, but dressed Thruster Legacy functional knee brace.

排除标准

  • have undergone knee surgery
  • the lateral tibiofemoral joint severe (tibio-femoral joint) disease
  • serious knee ligament laxity
  • knee flexion contracture (flexion contracture) than 20 degrees
  • unable to walk
  • the skin of metal (aluminum) allergy
  • lower extremity vascular lesions or swelling

结局指标

主要结局

VAS pain score

时间窗: 1 month

To the severity of the pain patients experience pain in itself to make a quantitative expression, assessment methods as follows: a horizontal line 10 cm in length, with zero as the most left office, on behalf of completely pain-free; the far right of the line can imagine the most severe pain, subjects were at rest and walking, according to their degree of sense of pain marked on the straight line. Reliability of this scale up to 0.94.

次要结局

  • WOMAC index(1 month)
  • SF-36(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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