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临床试验/NCT05061602
NCT05061602已完成不适用

Biomechanical and Viscoelastic Properties of Plantar Fascia in Diabetes Mellitus

Tülay Çevik Saldıran1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年9月20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
50
试验地点
1
主要终点
Biomechanical and Viscoelastic Properties

研究概览

简要总结

In this study, an attempt has been made to analyze the changes in soft tissue biomechanical properties of plantar surface in diabetes. The second aim of this study was to explore the relationships between fear of falling, physical performance, and plantar stiffness in patients with diabetes.

详细描述

Chronic diabetes can lead to ulceration in the plantar region and may result in amputation. Diabetes-related foot ulcerations are one of the most challenging complications of diabetes mellitus. Myotonometry, a technique to measure dynamic stiffness is preferred due to its noninvasiveness, easy employability, and rapid investigation. In this study, an attempt has been made to analyze the changes in soft tissue biomechanical properties of the plantar surface in diabetes. Increased plantar tissue stiffness is thought to alter the distribution of tensile stresses in the plantar soft tissues during gait. Combined with a reduction in plantar tissue thickness, these changes could collectively decrease the mechanical loads required to initiate soft tissue breakdown and thus lead to foot ulceration formation. Diabetes mellitus is a significant risk factor for falls in adults and is associated with an increase in fear of falling. Microvascular complications associated with DM result in multiple impairments including sensory deficits and muscle weakness due to peripheral neuropathy, loss of visual acuity due to retinopathy, and impaired postural control and falls due to vestibulopathy. The prevalence of falls and fear of falling are significantly higher in adults with diabetes mellitus. Assessment of mechanical properties of plantar tissues can aid in the early diagnosis of ulceration. In this study, an attempt has been made to analyze the changes in soft tissue biomechanical properties of the plantar surface in diabetes. The second aim of this study was to explore the relationships between fear of falling, physical performance, and plantar stiffness in patients with diabetes.

研究设计

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

入排标准

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

入选标准

  • Diagnosed with diabetes mellitus for more than three years
  • Individuals without a history of diabetes mellitus affirmed by a normal range of fasting blood sugar and hemoglobin A1C levels.
  • Age≥18 years

排除标准

  • History of central nervous system conditions
  • No visual and vestibular impairments
  • Amputation of the lower limb
  • History of fracture
  • Surgery of lumbar and lower limb
  • Having pain resulting in movement difficulty

结局指标

主要结局

Biomechanical and Viscoelastic Properties

时间窗: Day 1.

The biomechanical and viscoelastic properties of the plantar fascia will be measured with MyotonPRO device. The MyotonPRO (Tallin, Estonia) is a portable hand-held myotonometer. This device is non-invasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by different parameters such as tone, elasticity, and stiffness. 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.

次要结局

  • Fear of Falling(Day 1.)
  • Lower Limb Function(Day 1.)

研究者

发起方
Tülay Çevik Saldıran
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tülay Çevik Saldıran

Sponsor-Investigator

Bitlis Eren University

研究点 (1)

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