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临床试验/CTRI/2024/10/074780
CTRI/2024/10/074780已完成不适用

Comparing The Effect Of Whole Body Vibration And Virtual Reality On Balance, Pain And Quality Of Life In Diabetic Neuropathy Patients- A Randomized Controlled Trail

KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年10月13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
36
试验地点
1
主要终点
5 times sit to stand, timed up and go test, s-lanss pain score, Diabetic neuropathy symptom scale, Norfolk Quality of Life-Diabetic Neuropathy

研究概览

简要总结

India has one of the highest prevalence of type-2 diabetes mellitus (T2DM) in the world. Diabetic peripheral neuropathy (DPN) is the most common complication among DM patients. Diabetic Neuropathy detrimentally impacts an individual’s quality of life by causing balance impairments and chronic pain. 

Whole body vibration (WBV) is non invasive somatosensory stimulation which involves application of mechanical vibration stimulating neuromuscular pathway. It is easy to use and time efficient.   Despite the growing popularity of WBV and VR intervention, there is lack of literature about comparative studies specifically focusing on diabetic neuropathy. Hence this study aims to shed light upon the comparative effect of WBV and VR in patients with diabetic neuropathy.

Aim: To compare the effect of Whole Body Vibration and Virtual reality in diabetic neuropathy patients on balance, pain and quality of life.

Objective: To compare the effect of Whole Body Vibration and Virtual reality in diabetic neuropathy patients using 5 times sit to stand and timed up and go test, S-LANSS pain score, Diabetic neuropathy symptom scale, Norfolk Quality of Life-Diabetic Neuropathy.

Hypothesis

Null Hypothesis:

There will be no difference in effects of whole body vibration and virtual reality on balance, pain and quality of life in diabetic neuropathy patients.

Alternative Hypothesis:    There will be difference in effects of whole body vibration and virtual reality on balance, pain and quality of life in diabetic neuropathy patients.

Source of data: Tertiary care hospitals and diabetic clinics in Belagavi city

Study design: Experimental Study

Study Type: Randomized clinical Trail

Target population: Subject with type II diabetes mellitus diagnosed with diabetic neuropathy

Duration of Study: 12 months

Sample size: 36 (12 in each group)

Procedure: Prior to the commencement of the study, an Ethical Clearance will be obtained from the Institutional Ethical Committee

Study will be registered in CTRI prospectively.

Subjects will be briefed about the purpose of the study.

Participants will be selected based on inclusion and exclusion criteria.

A written inform consent will be taken from the participants in their own language and those consenting to participate in the study will be presented with the interventions.

Participants will be allotted into three study groups by envelop method.

Demographic data will be noted.

Group A: â€¢      Whole body vibration 3 sessions/week for 4 weeks.

•      Frequency of whole body vibration 30 Hz, amplitude 2 mm for 3×4 mins with 1 min of rest.

•      Conventional physiotherapy will be followed for next 30 mins

Group B:

•      Virtual Reality for 3 sessions/ week for 4 weeks.

•      virtual reality based games for 20 mins

•      For the first 4 session the therapeutic protocol will be implemented using Table tilt and VR walk.

•      For next 4 sessions the therapeutic protocol will be implemented using Archery and supermarket VR.

•      For next 4 sessions the therapeutic protocol will be implemented using Rollercoaster and rope walker VR.

•      Conventional physiotherapy will be followed for next 30 mins.

Group C:

The session will be for 45-50 mins for 3 days a week for 4 weeks. The session will include

Stance on heel/toes

Tandem standing

Side walking

Backward walking

One leg stance

Marching

Sit to stand

Stairclimbing

Obstacle walking

Treadmill walking

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

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

入选标准

  • Willingness to participate, Adults with type II diabetes mellitus diagnosed with diabetic neuropathy, Independent community ambulation, intact cognition.

排除标准

  • Other neuropathy such as GBS, leprosy, CIPN,Any other neurological condition such as dementia, stroke, Parkinson and any cardiac condition, Cancer and cancer survivors, History of vertigo and BPPV, Lower limb fracture with acute stage or deformed, Any other condition associated with high risk of fall, Kidney or bladder stones.

结局指标

主要结局

5 times sit to stand, timed up and go test, s-lanss pain score, Diabetic neuropathy symptom scale, Norfolk Quality of Life-Diabetic Neuropathy

时间窗: Baseline and 4 week after intervention.

次要结局

未报告次要终点

研究者

发起方
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Aakanksha Gujar

KAHER Institute of Physiotherapy

研究点 (1)

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