跳至主要内容
临床试验/CTRI/2024/10/075969
CTRI/2024/10/075969尚未招募不适用

Therapeutic Knee Brace to Facilitate and Correct Movements of the Knee Joint

School of Physiotherapy RK University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Numerical Pain Rating Scale (NPRS) Scale.

研究概览

简要总结

Therapeutic Knee Brace aimed at facilitating and correcting movements of the knee joint. The project will involve a two-stage study to assess its effectiveness on both healthy individuals and individuals with knee pain disorders with the tehrpautic knee brace and traditionally available knee brace.

Stage 1: Study on Healthy Individuals

  • Objective: To evaluate knee function in normal individuals under different conditions.

  • Method: Each participant will be assessed in three scenarios:

  1. Without a knee brace (no external support).

  2. Using the Conventional  Knee Brace(the newly developed device).

  3. Using a Therapeutic knee brace (standard brace available on the market).

Stage 2: Study on Individuals with Knee Pain Disorders

  • Objective: To evaluate the impact of the Therapeutic Knee Brace on individuals with existing knee pain or mobility issues.

  • Method: Each participant will be assessed under the same three conditions as in Stage 1:

  1. Without a knee brace.

  2. Using the Conventional  Knee Brace.

  3. Using a Therapeutic Knee Brace.

Outcome Measures

For both stages of the study, the pre- and post-intervention results will be measured immediately after brace use, using the following tools:

  • Numerical Pain Rating Scale (NPRS): To assess pain levels.

  • Timed Up and Go (TUG) Test: To evaluate functional mobility and overall movement efficiency.

The results will help determine the effectiveness of the Therapeutic Knee Brace in improving knee function and managing pain, compared to no brace and a conventional brace.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Individuals with knee pain, either unilateral or bilateral 2.Individuals who are Capable of performing basic physical activities (e.g., walking, climbing stairs).
  • Able to wear knee brace.

排除标准

  • Individuals with cognitive disorders.
  • History of Hospitalisation in last 6 months.

结局指标

主要结局

Numerical Pain Rating Scale (NPRS) Scale.

时间窗: With wearing therapeutic and conventional knee brace, before and after Numerical Pain Rating Scale (NPRS) will be performed.

次要结局

  • Time up and Go (TUG) Test.
  • Sit to Stand(With wearing therapeutic and conventional knee brace, before and after Sit to Stand test will be performed.)

研究者

发起方
School of Physiotherapy RK University
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Ahir Pooja Alabhai

School Of Physiotherapy, RK University.

研究点 (1)

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