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临床试验/CTRI/2024/01/062025
CTRI/2024/01/062025尚未招募2 期

Efficiency of galvanic vestibular stimulation on balance in type 2 diabetic patients

Amity institute of physiotherapy1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年2月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Static balance

研究概览

简要总结

As per WHO, 2020, India is having the largest number of diabetics and the recent estimates states that 69.2 million people are affected by diabetes in India. People with diabetes often develop multiorgan or structural and functional changes due to microvascular and macrovascular complications including effect on balance. The vestibular system contributes significantly to balance in static and dynamic conditions by providing spatially orienting information. The epidemiological studies conducted infer that 70% of diabetics suffer from vestibular dysfunction compared to people without diabetes. The dysfunction prevalence depends on chronicity of diabetes and higher HbA1C levels.

A pre-post experimental designed study is proposed to be conducted on 80 diagnosed type 2 diabetic male and female patients having HbA1c levels ≥ 7.0% to 9.0% with vestibular dysfunction and minimum 5 years history of diabetes. A standardized baseline balance score for inclusion will be considered. The blind, diagnosed diabetic peripheral neuropathy, subjects unable to stand on their own i.e. using an assistive device, having dizziness causing unsteadiness, any diagnosed neurological disorder, soft tissue injury, foot or leg amputation, and/or other surgery done in last 3 months will be excluded. Patients with metallic objects implanted in the skull, cardiac pacemakers, or epilepsy restricting the use of GVS will not participate in the study.

Ethical clearance will be obtained from Institutional ethical committee before commencing the project. After receiving the informed consent form, the subjects will be screened for diabetic vestibular dysfunction using the screening tool and tests. The screened patients will be allocated in four groups: Galvanic vestibular stimulation (GVS) group, Vestibular rehabilitation (VR) exercise group, GVS with VR exercise group and control group. The outcome measures will be based on pre and post static and dynamic balance through Fitknees device.

GVS is a non-invasive procedure and do not affects in the middle ear disorders. It is effective in the equilibrium disturbance and nystagmus through stimulation of the vestibulo-cochlear nerve and activation of otolithic and semi-circular canal neurons A galvanic current generator with two electrodes to be placed on the mastoid in a headband will be used to perform the GVS stimulation. Each subject will receive stimulation three times a week with sessions to be lasting for 20 minutes. The applied voltage will be set just below the threshold of the individual. VR exercises are designed to promote vestibular adaptation and substitution. The goal of VR exercises is to enhance gaze stability, postural stability and thereby improves general coordination It will be given 3 times/week for 6 weeks.

The study aims to screen diabetic patients with vestibular dysfunction and to find the efficacy of galvanic vestibular stimulation and vestibular rehabilitation exercises on balance in such patients

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • Diagnosed type 2 diabetic patients having HbA1c levels ≥ 7.0% to 9.0% with minimum 5 years history of diabetes. With vestibular dysfunction (Will be screened through screening tests). Baseline balance scores for inclusion Functional reach test score- Males≤35cm and Females≤33cm Timed get up and go score≥10.7seconds Single leg stance time for age: 40-49 years: score greater than 29 seconds, age: 50-59 years-score greater than 27 seconds, age: 60-69years.
  • score greater than 22 seconds and 70-75years- score greater than 14 seconds.

排除标准

  • Age less than 40 years.

结局指标

主要结局

Static balance

时间窗: Static balance | Dynamic balance | At baseline and 6 weeks post intervention

Dynamic balance

时间窗: Static balance | Dynamic balance | At baseline and 6 weeks post intervention

次要结局

未报告次要终点

研究者

发起方
Amity institute of physiotherapy
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Prerna Mohan Saxena

Amity Institute of Physiotherapy, Amity Institute of health and allied sciences

研究点 (1)

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