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临床试验/CTRI/2024/09/073501
CTRI/2024/09/073501
尚未招募
不适用

Effect of multimodal vestibular rehabilitation exercises on postural control, gait and risk of fall in patients with Type 2 Diabetes Mellitus of vadodara,Gujarat

Dr Fatema Daruwala PT1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月17日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Dr Fatema Daruwala PT
入组人数
40
试验地点
1
主要终点
mCTSIB (Modified Clinical test of Sensory interaction in Balance), DGI (Dynamic Gait Index)

概览

简要总结

Diabetes mellitus is chronic metabolic condition characterized by elevated blood glucose level which may result from inability of body to produce insulin, resist insulin action or both.Patients with diabetes have higher incidence of vestibular dysfunction which may increase the risk of fall and it could be an independant mediator of association between diabetes and falls.

Need of study : Routinely type 2 Diabetes patients are managed by aerobic training, fitness training and advice on diet management.There is paucity of studies that focus on vestibular dysfunction and simultaneous management of all three sensory input systems, sensory interaction, modification of base of support, cognition and other motor dysfunctions in patients with diabetes without neuropathy.

Research question : 1) What is the prevalence of vestibular dysfunction in type 2 diabetes?

  1. will 4 weeks of Multimodal Vestibular Rehabilitation protocol be effective in type 2 Diabetes patients?

In this study prevalence of vestibular dysfunction in type 2 Diabetes mellitus will be evaluated. Patients of type 2 DM  with vestibular dysfunction will be divided in two groups  Group 1 : Multimodal Vestibular Rehabilitation Exercises Group 2 : Standard Exercise Protocol. Outcome measures will be evaluated at baseline and at the end of 4 weeks intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Type2 DM (with controlled blood glucose level) with vestibular dysfunction identified by mCTSIB 2.Age 30 to 60 years 3.Able to walk without assistive device 4.Both male and female.

排除标准

  • 1.Any other significant Cardiopulmonary, neurological (hemiparesis, myelopathy etc) or lower limb orthopedic (amputation, fracture etc) impairments 2.Clear causes of inner ear injury,BPPV, Vestibular neuritis etc 3.Presence of nephropathy,retinopathy, neuropathy (Screened out by Michigan neuropathy scale) 4.Cervical neurological symptoms (radiculopathy, myelopathy, etc), limited ROM of neck, cervical spine instability,history of neck surgery, recent neck trauma 5.Those not willing to participate 6.Those unable to comprehend the command.

结局指标

主要结局

mCTSIB (Modified Clinical test of Sensory interaction in Balance), DGI (Dynamic Gait Index)

时间窗: mCTSIB (Modified Clinical test of Sensory interaction in Balance), DGI (Dynamic Gait Index) will be evaluated at baseline and at the end of 4 weeks intevention

次要结局

  • ABC (Activities specific balance confidence scale)(ABC Scale will be taken at baseline and at the end of 4 weeks intervention)

研究者

发起方
Dr Fatema Daruwala PT
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Fatema Daruwala PT

Drs. Kiran and pallavi patel Global University

研究点 (1)

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