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CTRI Number  CTRI/2025/08/092314 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   electrical nerve stimulation and transcranial stimulation for balance problems in older adults  
Scientific Title of Study   Comparative study of transcutaneous electrical nerve stimulation and transcranial direct current stimulation in older adults with vestibular hypofunction 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pratima Sudhir Sarwadikar 
Designation  Assistant Professor  
Affiliation  Dr. D. Y. Patil College of Physiotherapy, Pimpri, Pune 
Address  Anyrag Homes Sector 27a Plot 478 Anurag Homes Flat 202 Behind Tjsb Bank Nigdi Pradhikaran Pune
Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411035
India 
Phone  09607500774  
Fax    
Email  pratima.sarwadikar@dpu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Pratima Sudhir Sarwadikar 
Designation  Assistant Professor  
Affiliation  Dr. D. Y. Patil College of Physiotherapy, Pimpri, Pune 
Address  Dr D Y Patil College of Physiotherapy Dr D Y Patil Vidyapeeth Pimpri Pune
Dr D Y Patil College of Physiotherapy Dr D Y Patil Vidyapeeth Pimpri Pune
Pune
MAHARASHTRA
411018
India 
Phone  09607500774  
Fax    
Email  pratima.sarwadikar@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Pratima Sudhir Sarwadikar 
Designation  Assistant Professor  
Affiliation  Dr. D. Y. Patil College of Physiotherapy, Pimpri, Pune 
Address  Anyrag Homes, Sector 27a, Plot 478, Anurag Homes, Flat 202, Behind Tjsb Bank, Nigdi Pradhikaran, Pune
Anurag Homes
Pune
MAHARASHTRA
411035
India 
Phone  09607500774  
Fax    
Email  pratima.sarwadikar@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr. D. Y. Patil College of Physiotherapy Sant Tukaram Nagar Pimpri pune Mahrashtra India 411018 
 
Primary Sponsor  
Name  Dr D Y Patil College of Physiotherapy  
Address  Sant Tukaram Nagar Pimpri Pune Maharashtra India 411018 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pratima Sudhir Sarwadikar  Dr. D. Y Patil College of Physiotherapy  Dr D Y Patil Physiotherapy OPD ground floor Sant Tukaram Nagar pimpri pune 411018
Pune
MAHARASHTRA 		 09607500774

pratima.sarwadikar@dpu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H818||Other disorders of vestibular function,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable  
Intervention  Transcranial direct current stimulation, Transcutaneous Electrical Nerve stimulation and Vestibular Rehabilitation   3 times in week one group will receive TDCS and VR, Other will receive TENS and VR 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Participants with normal and corrected vision with optimal aid
Participants have history of fall in last one year
Participants with previous episodes of dizziness within 2 years
Participants with other controlled comorbidities 
 
ExclusionCriteria 
Details  Participants with severe hearing impairment
participants weak to undergo vestibular assessment
Participants with acute ear infection
Cranial surgery
Cardiac pacemakers 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Dizziness handicap inventory Vertigo Symptom scale Berg balance scale   1st day of intervention and at the end of 4 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 1/ Phase 2 
Date of First Enrollment (India)   01/01/2026 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code
    Response - None of the above

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pratima.sarwadikar@dpu.edu.in].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Ethical Clearance has obtained from IEC
Study is registered under CTRI
Screening will be done based on inclusion and exclusion criteria
Patient will informed about study procedure and benefits and recruited
Randomization of sample will be done
Assessment of baseline characteristics
Pre intervention outcome measurement will be done
Participants will divide into 2 groups
Intervention will be given 3 times per week for 12 session 
Post intervention will be done
Analysis of data will be done
Result will calculated 
 
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