| CTRI Number |
CTRI/2024/01/062025 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
09/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To find the efficacy of galvanic vestibular stimulation as an intervention for improving balance in patients with type 2 diabetes mellitus |
|
Scientific Title of Study
|
Efficiency of galvanic vestibular stimulation on balance in type 2 diabetic patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prerna Mohan Saxena |
| Designation |
PhD Scholar |
| Affiliation |
Amity Institute of Physiotherapy, Amity Institute of health and allied sciences |
| Address |
Amity Institute of Physiotherapy, Amity Institute of health and allied sciences, Amity University, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
919999456988 |
| Fax |
|
| Email |
prernasaxena.88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjib Kumar Das |
| Designation |
Associate Professor |
| Affiliation |
Amity Institute of Physiotherapy, Amity Institute of health and allied sciences |
| Address |
Amity Institute of Physiotherapy, Amity Institute of health and allied sciences, Amity University, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
918879485847 |
| Fax |
|
| Email |
skdas@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Prerna Mohan Saxena |
| Designation |
PhD Scholar |
| Affiliation |
Amity Institute of Physiotherapy, Amity Institute of health and allied sciences |
| Address |
Amity Institute of Physiotherapy, Amity Institute of health and allied sciences, Amity University, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
919999456988 |
| Fax |
|
| Email |
prernasaxena.88@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Amity institute of physiotherapy |
| Address |
Amity Institute of Physiotherapy, Amity Institute of health and allied sciences, Amity University, Noida |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prerna Mohan SaxenaPT |
Amar Jyoti Institute of Physiotherapy, GF OPD physiotherapy department |
Karkardooma, Delhi
East
DELHI |
9999456988
prernasaxena88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amity University Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTROL |
SELF TREATMENT, 6 weeks intervention |
| Intervention |
Galvanic vestibular stimulation(GVS), vestibular rehabilitation exeercises(VR) |
4 groups-
1st- GVS
2nd- VR alone
3rd- GVS and VR
4th- Control
6 weeks intervention for each group |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
Age less than 40 years |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Static balance
Dynamic balance |
Static balance
Dynamic balance
At baseline and 6 weeks post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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
|