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CTRI Number  CTRI/2024/06/068536 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 27/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Association between older, overweight people lower limb function with knee arthritis and standing balance. 
Scientific Title of Study   ASSOCIATION BETWEEN LOWER EXTREMITY FUNCTION AND STANDING BALANCE AMONG OBESE ELDERLY POPULATION WITH OSTEOARTHRITIS OF KNEE JOINT RESIDING IN COMMUNITY: A CROSS-SECTIONAL STUDY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Payal Pankaj Sancheti 
Designation  1st year MPT(Community Physiohterapy) 
Affiliation  Dr Vithalrao Vikhe Patil College of Physiotherapy Ahmednagar 
Address  Department of Community Physiotherapy Basement Dr Vithalrao Vikhe Patil College of Physiotherapy Vilad Ghat Ahmednagar Ahmadnagar MAHARASHTRA 414111 India

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  9325448539  
Fax    
Email  payal.sancheti2000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shyam D Ganvir 
Designation  Principal & Professor Department of Community Physiotherapy 
Affiliation  Dr Vithalrao Vikhe Patil College of Physiotherapy Ahmednagar 
Address  Department of Community Physiotherapy Basement Dr Vithalrao Vikhe Patil College of Physiotherapy Vilad Ghat Ahmednagar Ahmadnagar MAHARASHTRA 414111 India

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  8554990224  
Fax    
Email  shyam.ganvir@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shyam D Ganvir 
Designation  Principal & Professor Department of Community Physiotherapy 
Affiliation  Dr Vithalrao Vikhe Patil College of Physiotherapy Ahmednagar 
Address  Department of Community Physiotherapy Basement Dr Vithalrao Vikhe Patil College of Physiotherapy Vilad Ghat Ahmednagar Ahmadnagar MAHARASHTRA 414111 India

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  8554990224  
Fax    
Email  shyam.ganvir@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  DVVPFS College of Physiotherapy Ahmednagar 
Address  DVVPFS COLLEGE OF PHYSIOTHERAPY opposite government milk dairy MIDC Vilad Ghat Ahmednagar 
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 
Payal Pankaj Sancheti  DVVPFS College of Physiotherapy vilad ghat Ahmednagar  Department of Community Physiotherapy block one basement Dvvpfs College of Physiotherapy Ahmednagar Ahmadnagar MAHARASHTRA
Ahmadnagar
MAHARASHTRA 		 9325448539

payal.sancheti2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DVVPFS College of Physiotherapy Institutional ethical Committee Ahmednagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Obese and Osteoarthritis of Knee Joint 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1 Both Male and Female individuals
2 Age more than 50 years
3 Obese patients BMI more than 25 kg/m2 as per WPRO
4 Patients having Osteoarthritis of knee joint (UL or BL)diagnosed using ACR Criteria 
 
ExclusionCriteria 
Details  1 Recent knee surgery
2 History of periarticular fracture
3 Sciatica Pain
4 Rheumatoid arthritis and inflammatory arthritis
5 Neurologic problems such as hemiplegia or cognitive impairment
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1 Lower Extremity Function Scale(LEFS)
2 Community Balance and Mobility Scale(CBMS)
3 BMI 		 Immediately 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   20/06/2024 
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)   Open to Recruitment 
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   Obesity and Osteoarthritis of knee joint can lead to decrease in Lower extremity function and Balance. Obesity is also a leading factor for Osteoarthritis of knee Joint leading to decline in Lower extremity function and Balance. Understanding this association can provide valuable insights into the management and intervention strategies for improving mobility and stability in elderly individuals with knee osteoarthritis who are also obese and living in community settings. This study is aimed to find out association between lower extremity function and balance in obese elderly with Osteoarthritis of knee joint. The result of this study will help us in better understanding of factors affecting balance and mobility and also how obesity and lower extremity function affects balance in Knee OA individuals. Also this study will help in improving the protocol for obese elderly OA knee patients suffering from stability and mobility issues. 
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