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临床试验/CTRI/2024/05/067744
CTRI/2024/05/067744已完成不适用

Association Between Plantar Pressure and Fall Risk in Patients with Diabetic Neuropathy: An Observation Study

Nitte Institute of Physiotherapy NITTEDeemed To be University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
1. Plantar pressure analysis system

研究概览

简要总结

Diabetes mellitus (DM) is the collective term with main symptom of chronic hyperglycemia leading to one of the most important complication-Diabetic neuropathy. Diabetic patients with neuropathy are at high risk for the development of ulcers which might lead to falls due to high plantar pressure and sensory loss. Typically, in terms of diabetic neuropathy population, it is important to assess the factors that might cause falls in this population. As these populations are more prone to falls, factors responsible for falls should be identified. Physiotherapists who are qualified to prescribe exercise should know these factors with the goal of preventing falls. Additionally, comprehending the fall risk among the diabetic population is essential for conducting successful fall prevention programs and might aid in knowledge transfer to other developing nations. There is a dearth of studies that compare plantar pressure and fall risk in diabetic neuropathy patients in large populations between TUG and PP, using plantar pressure force systems (portable and wireless), especially in the Indian population. Hence, this study aims to find the association between plantar pressure and fall risk in diabetic neuropathy patients leading to falls. The result of the study will be useful for the therapist to rehabilitate and educate the patient about the fall risk and how to prevent it. In addition, these assessment methods are cost effective and portable which benefits the patient and the therapist.

研究设计

研究类型
Observational

入排标准

年龄范围
35.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • People diagnosed with Diabetic Neuropathy
  • People able to stand on both feet
  • People without foot ulcers
  • 10g Monofilament test ranging from 1.65 – 6.65.

排除标准

  • Neurological disorders which affect balance and cognition
  • People with foot cons
  • Diabetic foot ulcers
  • Amputated lower limbs
  • Recent lower limb surgery past 6 months
  • Recent fractures of lower limb past 6 months
  • Recent falls within 6 months.

结局指标

主要结局

1. Plantar pressure analysis system

时间窗: Assessment will be taken once at the beginning of the study

2. TUG test

时间窗: Assessment will be taken once at the beginning of the study

3. ABC-16 scale

时间窗: Assessment will be taken once at the beginning of the study

次要结局

未报告次要终点

研究者

发起方
Nitte Institute of Physiotherapy NITTEDeemed To be University
申办方类型
Other [ Nitte Institute of Physiotherapy, NITTE(Deemed To be University)]
责任方
Principal Investigator
主要研究者

Brahmi

Nitte Institute of Physiotherapy

研究点 (1)

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