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临床试验/NCT04444375
NCT04444375已完成不适用

Plantar Pain, Balance and Foot Function in Individuals With Diabetes Mellitus

Suleyman Demirel University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
the Portable Computerized Kinesthetic Equilibrium Device (SportKAT 550)

研究概览

简要总结

Diabetes Mellitus (DM) and increase of body mass index (BMI) are two one of the most common risk factors for plantar pain and related disability. The aim of our study was to evaluate the relationship between plantar pain, balance and foot function in diabetic DM patients has with different BMI.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
35 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • having plantar pain
  • and no change in BMI by more than 10% for at least 3 months
  • being volunteer to participate to the study

排除标准

  • having musculoskeletal surgery for foot
  • having neurological, orthopedic, and cardiovascular diseases
  • vision and hearing problems that may cause balance disorder

结局指标

主要结局

the Portable Computerized Kinesthetic Equilibrium Device (SportKAT 550)

时间窗: 6 months

balance

Foot Function Index

时间窗: 6 months

Foot Function Index of 23 items, and evaluates the pain, disability and activity limitation. The each of the pain and insufficiency subscales consist of 9 items and the activity limitation subscale includes 5 items. Patients score their foot pain level with Visual Analogue Scale (VAS) in various situations during the last 1 week. To calculate the scores of the index, the score of each item are summed, then divided by possible the maximum score can be obtained from the FFI. Higher scores indicate greater pain, disability and activity limitation level.

Manchester Foot Pain and Disability Index

时间窗: 6 months

Manchester Foot Pain and Disability Index consists of 4 subsections including 9 questions for inadequacy, 5 questions for pain, 3 questions for concern and 2 questions for difficulty. Each item is scored between 0-2. The total score is calculated by summing the scores from all items. Higher scores indicate worse health situation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Duray

Principal Investigator

Suleyman Demirel University

研究点 (1)

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