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CTRI Number  CTRI/2024/01/061480 [Registered on: 15/01/2024] Trial Registered Prospectively
Last Modified On: 06/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   comparing effects of transcranial direct current stimulation and virtual reality on depression after a stroke to improve the quality of life of patients 
Scientific Title of Study   Effect of Transcranial Direct Current Stimulation versus Virtual Reality on post stroke depression-A Randomised Clinical Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Raghavendrasingh Dharwadkar 
Designation  Assistant professor 
Affiliation  KAHER Institute of physiotherapy 
Address  KAHER Institute of physiotherapy, advanced physiotherapy centre OPD no.39 neurology department, OPD no.19, JNMC campus, nehru nagar, belagavi-590010, karnataka.

Belgaum
KARNATAKA
590010
India 
Phone  9886288225  
Fax    
Email  raghavendrasingh@klekipt.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Raghavendrasingh Dharwadkar 
Designation  Assistant professor 
Affiliation  KAHER Institute of physiotherapy 
Address  KAHER Institute of physiotherapy, advanced physiotherapy centre OPD no 39 neurology department, OPD no. 19, JNMC campus, nehru nagar, belagavi-590010, karnataka.

Belgaum
KARNATAKA
590010
India 
Phone  9886288225  
Fax    
Email  raghavendrasingh@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  Aaliya Sayad 
Designation  postgraduate student 
Affiliation  KAHER Institute of physiotherapy 
Address  KAHER Institute of physiotherapy, advanced physiotherapy centre OPD no 39, neurology department, OPD no.19,JNMC campus, nehru nagar,belagavi-590010, karnataka.

Belgaum
KARNATAKA
590010
India 
Phone  7972662408  
Fax    
Email  aaliya12112@gmail.com  
 
Source of Monetary or Material Support  
KLE Dr Prabhakar Kore Hospital and research centre, nehru nagar, belagavi 
 
Primary Sponsor  
Name  KAHER Institute of physiotherapy 
Address  KAHER Institute of physiotherapy,JNMC campus,nehru nagar,belagavi 
Type of Sponsor  Research institution and hospital 
 
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 Raghavendrasingh Dharwadkar  KAHER Institute of Physiotherapy  Advanced Physiotherapy Centre room no. 39, neurology department,OPD no-19 Sagar Floor KLE Dr. Prabhakar Kore Hospital Belagavi karnataka
Belgaum
KARNATAKA 		 9886288225

raghavendrasingh@klekipt.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics and Research Committee KAHER Institute of Physiotherapy   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  adults diagnosed with stroke between 21-75 years of age who have post stroke depression 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  transcranial direct current stimulation  stimulation will be given for 20 mins 5 times a week for 2 weeks 
Comparator Agent  virtual reality  videos will be shown for 20 mins 5 times a week for 2 weeks  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  -Subacute and chronic stroke participants with age group between 21-75 years of both genders.
-Participants with Hamilton depression rating scale between 8-23 (mild to moderate depression), Montreal cognitive assessment scale less than26 (mild cognitive impairment) and with Functional independence measure less than 5(helper-modified to helper-complete dependence)
 
 
ExclusionCriteria 
Details  Medically unstable patients, epilepsy, bipolar disorder, psychiatric disorder ,motion sickness, active nausea, hearing impairment, vomiting, loss of vision ,aphasia and vestibular disorders.

The presence of any materials within the body such as pacemakers, dentures, metal prostheses.

Any surgeries over the cranium.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
hamilton depression rating scale  day 1-day 10 
 
Secondary Outcome  
Outcome  TimePoints 
montreal cognitive assessment scale  day 1-day 10 
functional independence measure  day 1-day 10 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   N/A 
Date of First Enrollment (India)   18/01/2024 
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="0"
Months="6"
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 - NO
Brief Summary   We are conducting a research on transcranial direct current stimulation versus virtual reality on post stroke depression. 20 participants will be recruited in the study. They will be randomized to two groups on the basis of sealed envelope method. One group is transcranial direct current stimulation and the other is virtual reality. Treatment duration is 20 mins 5 times a week for 10 days.  
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