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临床试验/NCT05452551
NCT05452551已完成不适用

Investigation of Myotonometer Reliability in Evaluation of Plantar Fascia Biomechanical Properties in Individuals With Diabetes

İlke KARA, PT1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Muscle Tone (Hz)

研究概览

简要总结

The study aims to examine the intra-rater, inter-rater, and inter-session reliability of MyotonPRO in measuring plantar fascia mechanical properties in adults with diabetes.

详细描述

Therefore, changes occur in standing weight-bearing points, loading zones, and gait biomechanics. The thickened plantar fascia increases the risk of developing diabetic foot with increased peak-plantar pressure, and therefore, plantar fasciitis is more common in individuals with diabetes than in healthy individuals. The myotonometer studies showed that chronic diabetes history increases dynamic stiffness, which is one of the mechanical properties of the plantar fascia, and that as the severity of the disease increases, fascial stiffness also increases. The aim of the study is to examine the intra-rater, inter-rater, and inter-session reliability of MyotonPRO in measuring plantar fascia mechanical properties in adults with diabetes.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Body mass index < 30 kilogram/meter square
  • Willing to participate in the study
  • Diagnosed with Type 2 Diabetes
  • HbA1c level ≥ 6.5% mmol/mol
  • Fasting plasma glucose ≥126 mg/dl
  • Random plasma glucose ≥ 200 mg/d

排除标准

  • History of lower extremity injuries
  • Ulceration localized on plantar fascia
  • Age ≥ 65 years
  • Any use of medication that will affect muscle tone

结局指标

主要结局

Muscle Tone (Hz)

时间窗: Day 1

The muscle tone which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. After each application, the acceleration graph will be examined and if there is any deviation from the normal, the measurements will be repeated. Recordings will be reloaded into the software program and reported for each participant. The oscillation frequency (Hz) represents the resting muscle tone.

Logarithmic decrement

时间窗: Day 1

The muscle tone which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. After each application, the acceleration graph will be examined and if there is any deviation from the normal, the measurements will be repeated. Recordings will be reloaded into the software program and reported for each participant.

Stiffness (N/m)

时间窗: Day 1

The muscle tone which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. After each application, the acceleration graph will be examined and if there is any deviation from the normal, the measurements will be repeated. Recordings will be reloaded into the software program and reported for each participant.

次要结局

未报告次要终点

研究者

发起方
İlke KARA, PT
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

İlke KARA, PT

Investigator

Dokuz Eylul University

研究点 (1)

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