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临床试验/NCT07084922
NCT07084922已完成不适用

Association Between Plantar Pressure Distribution and Postural Balance Parameters in Individuals With Diabetic Foot

Medipol University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年6月28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
32
试验地点
1
主要终点
Postural balance assessment

研究概览

简要总结

This study aims to investigate the relationship between plantar pressure distribution and postural balance in individuals diagnosed with diabetic foot. Diabetic foot is a common and serious complication of diabetes that increases the risk of foot ulcers and falls. Due to nerve damage and changes in walking biomechanics, individuals with diabetic foot may experience abnormal pressure on the soles of their feet and poor balance.

The study includes 32 participants aged 40-65 years who have been clinically diagnosed with diabetic foot (Stage 0 or 1 according to the Meggitt-Wagner classification). Participants undergo plantar pressure assessment using a pedobarographic system and balance testing using a Wii Balance Board system under different standing conditions (eyes open/closed, single/double leg stance). The study aims to identify high-risk plantar regions and impaired balance patterns to guide early interventions, reduce ulcer risk, and prevent falls.

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
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged between 40 and 65 years
  • Diagnosed with diabetic foot at Stage 0 or Stage 1 according to the Meggitt-Wagner classification
  • No history of foot or ankle surgery
  • Able to walk independently without assistive devices
  • Clinically assessed as at risk for diabetic foot

排除标准

  • History of amputation in the foot or ankle
  • Previous foot or ankle surgery
  • Use of medications affecting balance or gait
  • Presence of any neurological or musculoskeletal disorder unrelated to diabetic foot that affects mobility or balance

结局指标

主要结局

Postural balance assessment

时间窗: first day of the study

Postural balance assessment in the study will be performed with 'Becure Balance System (Becure Global GmbH)'. Individuals will be evaluated for balance on the device with eyes open-closed, single foot-double foot.

Pedobarographic analysis

时间窗: first day of the study

Pedobarographic analysis and evaluation of postural balance are widely used by clinicians and researchers to examine the foot structure and to determine the loading patterns of the foot. The data are obtained with electronic sensors placed on the platform where the gait takes place. The sensors are directly connected to the platforms and the computer system programmed to perform foot analysis. With the pedobarography device, pressure distribution data in the foot are obtained in static condition. Foot plantar pressure analysis will be performed using the EsCoSCAN® static pedobarographic assessment device. During the analysis, the individual will be made to stand without moving while looking straight ahead in the standing position for static analysis.

Demographic Information Form

时间窗: first day of study

The patient's demographic information, including height, weight, age, and diabetes type (Type 1 or Type 2), will be recorded using this form. Body Mass Index (BMI) will be calculated based on the recorded height and weight data (BMI = weight \[kg\] / height² \[m²\]

次要结局

未报告次要终点

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yağmur UYSAL

Lecturer

Medipol University

研究点 (1)

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