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临床试验/CTRI/2025/07/092007
CTRI/2025/07/092007尚未招募不适用

Establishing Test-Retest Reliability of Pressure Biofeedback in Measuring Gastrocnemius Muscle Activation in Adults with Bilateral Knee Osteoarthritis

Yashasvi Parmar1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年8月11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
104
试验地点
1
主要终点
Pressure Biofeedback Unit

研究概览

简要总结

Osteoarthritis (OA) is a prevalent degenerative joint disorder that commonly affects the knee joint, leading to pain, stiffness, and functional limitations in adults. Among the muscles involved in knee function, the gastrocnemius plays a crucial role in knee flexion and ankle plantarflexion, contributing significantly to mobility and balance. Hence, the accurate measurement of gastrocnemius muscle activation is essential for understanding its role in managing OA symptoms and developing targeted rehabilitation interventions. Pressure biofeedback devices, traditionally used for muscle activation, offer a non-invasive method to measure muscle activity during specific tasks or exercises. In OA patients, the variability in muscle function due to pain, inflammation, and compensatory patterns makes using a tool that provides dependable and repeatable results crucial. However, for the pressure biofeedback tool to be a reliable measure of gastrocnemius muscle activation in symptomatic OA adults, its test-retest reliability must be established. This research aims to study the test-retest reliability of the pressure biofeedback unit in measuring gastrocnemius muscle activation while performing the isometric gastrocnemius contraction in long sitting**.** It isa single-group Cross-Sectional Study.Participants will be recruited based on inclusion and exclusion criteria. The participants will complete the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scale to assess the baseline severity of their symptoms, including pain, stiffness, and functional limitations. Following this, they will perform gastrocnemius contraction in a long sitting position under the supervision of a trained physiotherapist. Baseline data on gastrocnemius muscle activation will be collected using a pressure biofeedback unit to measure changes in pressure as an indicator of muscle activation. Participants will then return 48 hours later to perform the gastrocnemius contraction in long sitting again under the same conditions, and the measurements will be repeated to evaluate the test-retest reliability of the device. Efforts will be made to maintain consistency across both sessions by providing standardized instructions and using the same equipment setup.

研究设计

研究类型
Observational

入排标准

年龄范围
45.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Age more than 50-80 years
  • Both male and female
  • Knee OA Grade I, II, and III based on the Kellgren and Lawrence grading system
  • A patient who can follow simple verbal commands.

排除标准

  • Knee Osteoarthritis Grade IV based on the Kellgren and Lawrence grading system
  • Injuries surrounding the gastrocnemius muscle
  • Any recent injury or surgery
  • History of neurological conditions.

结局指标

主要结局

Pressure Biofeedback Unit

时间窗: Baseline and 48 hours later (i.e. 2 days later)

次要结局

未报告次要终点

研究者

发起方
Yashasvi Parmar
申办方类型
Other [nil]
责任方
Principal Investigator
主要研究者

Yashasvi Parmar

MMIPR, Maharishi Markandeshwar (Deemed to be University)

研究点 (1)

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