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CTRI Number  CTRI/2025/04/085210 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 02/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   The Modified Fall Efficacy Scale is used to measure changes in fall fear in the older population. 
Scientific Title of Study   Fluctuation in fear of fall in elderly population using Modified Fall Efficacy Scale 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vedanti Kiran Patil 
Designation  post graduate 
Affiliation  college of physiotherapy sumandeep vidyapeeth deemed to be university 
Address  College of Physiotherapy PG1 classroom 2nd floor department of neurological and psychosomatic disorders Sumandeep Vidyapeeth an institution deemed to be university pipariya waghodiya vadodara gujarat 391760 India Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9284627327  
Fax    
Email  vedanti18072001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.G.P.Kumar 
Designation  Dean and Professor 
Affiliation  college of physiotherapy sumandeep vidyapeeth deemed to be university 
Address  Deans cabin on ground floor College of Physiotherapy Sumandeep Vidyapeeth an institution deemed to be university at and post pipariya taluka waghodiya vadodara gujarat 391760 India Vadodara
College of physiotherapy
Vadodara
GUJARAT
391760
India 
Phone  8238034454  
Fax    
Email  principal.physiotherapy@sumandeepvidyapeethdu.edu.in  
 
Details of Contact Person
Public Query  
Name  Vedanti Kiran Patil 
Designation  post graduate 
Affiliation  college of physiotherapy sumandeep vidyapeeth deemed to be university 
Address  College of physiotherapy, Staffroom, Ground floor, Department of neurological and psychosomatic disorders, Sumandeep Vidyapeeth Deemed To be University, Piparia, Waghodia.
College of physiotherapy, Staffroom, Ground floor, Department of neurological and psychosomatic disorders, Sumandeep Vidyapeeth Deemed To be University, Piparia, Waghodia.
Vadodara
GUJARAT
391760
India 
Phone  9284627327  
Fax    
Email  vedanti18072001@gmail.com  
 
Source of Monetary or Material Support  
Piparia Gram Panchayat Office, Piparia, Wghodia, Vadodara, Gujrat, India, 391760 
 
Primary Sponsor  
Name  vedanti kiran patil 
Address  College of Physiotherapy Sumandeep Vidyapeeth an institution deemed to be university at and post pipariya taluka waghodiya vadodara gujarat 391760 India Vadodara 
Type of Sponsor  Other [self funded] 
 
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 vedanti kiran patil  college of physiotherapy sumandeep vidyapeeth deemed to be university  PG Classroom on ground floor College of Physiotherapy Sumandeep Vidyapeeth an institution deemed to be university at and post pipariya taluka waghodiya vadodara gujarat 391760 India Vadodara
Vadodara
GUJARAT 		 9284627327

vedanti18072001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Instituational Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  elderly population 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Subjects who are ambulating on their own with or without walking aids.
Subjects with or without any comorbidities.
Subjects with normal or corrected vision.

 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
modified fall efficacy scale  Patient will be assessed and after we will take the modified fall efficacy scale and checked every month for 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  0 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "47"
Final Enrollment numbers achieved (India)="47" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/04/2025 
Date of Study Completion (India) 31/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/12/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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   Subjects will be assessed according to the assessment format (Annexure III). They are also examined with Mini Mental State Examination (Annexure IV) and Geriatric Depression Scale (Annexure V). The subjects will be asked to complete the Modified Fall Efficacy scale in their choice of language. If subject can’t read. A one-to-one interview will be held. If a subject has any queries then it will be clarified by the investigator. The subject will be approached again for the second cycle of assessment after 3 weeks of the previous assessment, or on the same week of the next month (i.e., the 1st or 2nd week of the next month likewise). The same will be repeated for each subject till they complete 6 cycles of assessment. 
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