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CTRI Number  CTRI/2024/02/062877 [Registered on: 20/02/2024] Trial Registered Prospectively
Last Modified On: 13/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A comparison between the 8 Foot Up and Go Test and the Timed Up and Go Test to estimate fall risk in elderly people living in communities. 
Scientific Title of Study   Comparing the Efficacy of 8 Foot Up and Go Test and Timed Up and Go Test to Predict Risk of Fall in Community Dwelling Elders. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prashansa Christian 
Designation  PG student  
Affiliation  College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be university. 
Address  College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be university, piparia, waghodia, vadodara, 391760

Vadodara
GUJARAT
391760
India 
Phone  9328809886  
Fax    
Email  prashansa412001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nensi Gandhi 
Designation  Assistant professor 
Affiliation  College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be university. 
Address  College of physiotherapy, Sumandeep Vidyapeeth Deemed to be university, piparia, waghodia, vadodara, 391760

Vadodara
GUJARAT
391760
India 
Phone  9913577382  
Fax    
Email  drnensi.cop@sumandeepvidyapeethdu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Nensi Gandhi 
Designation  Assistant professor 
Affiliation  College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be university. 
Address  College of physiotherapy, Sumandeep Vidyapeeth Deemed to be university, piparia, waghodia, vadodara, 391760

Vadodara
GUJARAT
391760
India 
Phone  9913577382  
Fax    
Email  drnensi.cop@sumandeepvidyapeethdu.edu.in  
 
Source of Monetary or Material Support  
Prashansa Christian, College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be university. 
 
Primary Sponsor  
Name  Prashansa Christian 
Address  College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University, Piparia , Waghodia, Vadodara, 391760 
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 Nensi Gandhi  Community dwelling elderly adults in and around 15 kms of Dhiraj Hospital  College of Physiotherapy, Sumandeep Vidyapeeth deemed to be University Piparia, Waghodia, Vadodara 391760
Vadodara
GUJARAT 		 9913577382

drnensi.cop@sumandeepvidyapeethdu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee (SVIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Elderly people  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age group 60-80 years.
Both genders are included (male & female).
Elders who is functionally independent individuals (with no walking aids). 
 
ExclusionCriteria 
Details  History of severe cardio vascular issues and recent surgeries.
Any past history of diagnosed severe neurological disorder or severe musculoskeletal conditions of lower limb.
Any other Diseases that might have an influence on balance or gait.
Person who is bed ridden.
Person who is blind or deaf.
Person with communication problems. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
8 Foot Up and Go Test
Timed Up and Go Test 		 1:1 
 
Secondary Outcome  
Outcome  TimePoints 
8 Foot Up & Go Test
Timed Up & Go Test
 		 1:1 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/02/2024 
Date of Study Completion (India) 05/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The proposed study will be submitted to Sumandeep Vidyapeeth Institutional Ethics committee (SVIEC) for ethical approval. Once the study is approved by Sumandeep Vidyapeeth Institutional Ethical Committee (SVIEC), the elderly people will be approached from community dwelling and explained about the study. Those who are willing to participate in the study will be requested to fill the informed consent form (Annexure I). A Participant information sheet (Annexure II) will be given to the participants. The participants will be screened through (Annexure III) Assessment Sheet where they will be recruited on the basis of inclusion and exclusion criteria. Then under comfortable and safe surrounding will ask the individual to perform 8 Foot Up and Go Test and Timed Up and Go Test as explained. Scoring will be noted according to the interpretation of tests. Then the results will be statistically analyzed.

 
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