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临床试验/CTRI/2025/07/090069
CTRI/2025/07/090069尚未招募不适用

Association between foot indices and balance in diabetic peripheral neuropathy

未提供1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年7月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
54
试验地点
1
主要终点
Bergs Balance Scale

研究概览

简要总结

This research explores the association between foot structure and balance in individuals with and without diabetic peripheral neuropathy(DPN), a common and serious complication of type 2 diabetes. DPN results from prolonged hyperglycaemia, leading to nerve damage, sensory deficits, muscle weakness, and compromised postural control. These effects increase the risk of falls, ulcers and amputations significantly impacting the quality of life.

The study is driven by the hypothesis that changes in foot morphology, measured by foot indices such as the Staheli Index, Chippaux-Smirak Indexand Clarke’s angle, Harris imprint Index, Arch Index may be linked to balance impairments in DPN patients. It also investigates whether balance deficits are primarily due to neuropathy or if altered foot structure plays an independent role. Using validated tools like Berg Balance Scale(BBS) and Single Leg Stance (SLS) test, balance performance is assessed alongside foot arch evaluation and sensory testing with monofilaments.

The study adopts a cross-sectional design involving 54 participants aged greater than or equal to 50 years, equally divided into DPN AND non - DPN groups, recruited from hospitals and clinics in Dakshina Kannada. Inclusion and Exclusion criteria ensure accurate diagnosis and control of confounding conditions.Data is collected on demographics, diabetic history, foot structure, sensory response and balance.

Statistical analysis involves correlating foot indices with balance measure to determine significant relationships. The study aims to identify early predictors of balance dysfunction to inform preventive and personalised physiotherapy interventions.

By addressing a gap in existing literature, this research highlights the importance of early detection of biomechanics foot changes and their impact on functional stability in diabetic populations. Ultimately, the findings aim to contribute to fall prevention strategies, reduce healthcare costs, and improve patient outcomes through targeted rehabilitation focused on both sensory and structural foot health.

研究设计

研究类型
Observational

入排标准

年龄范围
50.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Diabetic individuals with and without DPN diagnosis; Diagnosis of DPN by Nerve conduction study; Ability to walk independently; Willingness to provide informed consent;.

排除标准

  • History of lower limb amputation or major foot deformity unrelated to DPN; Neurological disorders; vestibular disorders; musculoskeletal conditions that affect balance and mobility example Parkinsons disease stroke dizziness fractures acute osteoarthritis Severe visual impairment ; Active foot ulcers or infections ;.

结局指标

主要结局

Bergs Balance Scale

时间窗: Baseline and immediately after performance of the test.

Single leg stance

时间窗: Baseline and immediately after performance of the test.

次要结局

  • Foot Indices.
  • Monofilament test(Baseline and immediately after the performance of the test.)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Farha Fathima M F

Alva’s College of Physiotherapy and Research centre

研究点 (1)

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