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CTRI Number  CTRI/2023/12/060974 [Registered on: 29/12/2023] Trial Registered Prospectively
Last Modified On: 27/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to find the relationship between toe grip strength and knee function in patients with knee osteoarthritis 
Scientific Title of Study   Correlation of toe grip strength with dynamic balance and mobility in individuals with knee osteoarthritis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Miqdad Ashraf 
Designation  Student 
Affiliation  Father Muller College of Physiotherapy 
Address  Father Muller College of Physiotherapy, a unit of Father Muller Charitable Institutions, Kankanady, Mangalore
Father Muller Charitable Institutions, Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575002
India 
Phone  7736705673  
Fax    
Email  miqdadashraf.kh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sydney Roshan Rebello 
Designation  Professor 
Affiliation  Professor 
Address  Father Muller College of Physiotherapy, a unit of Father Muller Charitable Institutions, Kankanady, Mangalore
Father Muller Charitable Institutions, Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575002
India 
Phone  9343569219  
Fax    
Email  sydnypt@fathermuller.in  
 
Details of Contact Person
Public Query  
Name  Miqdad Ashraf 
Designation  Student 
Affiliation  Father Muller College of Physiotherapy 
Address  Father Muller College of Physiotherapy, a unit of Father Muller Charitable Institutions, Kankanady, Mangalore
Father Muller Charitable Institutions, Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575002
India 
Phone  7736705673  
Fax    
Email  miqdadashraf.kh@gmail.com  
 
Source of Monetary or Material Support  
Rajiv Gandhi University of Health Sciences, 4th T block, Jayanagar, Bengaluru-560041, Karnataka, India 
 
Primary Sponsor  
Name  Rajiv Gandhi University of health Sciences 
Address  4th T Block, Jayanagar, Bengaluru- 560041, Karnataka, India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Father Muller College of Physiotherapy  Kankanady, Mangalore-575002, Karnataka, India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dsouza Cyanna Joseph  Father Muller Medical College Hospital  Physiotherapy OPD, Basement 2, Asha Kiran, Department of Physiotherapy, Father Muller Medical College hospital, Kankanady, Mangalore
Dakshina Kannada
KARNATAKA 		 9019569255

cyannadsouza11@fathermuller.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Diagnosed with knee osteoarthritis according to the scale described by Kellgren and Lawrence (≥Grade 2- minimal osteoarthritis with definite osteophytes and possible joint space narrowing on radiograph)
3. Knee osteoarthritis for a duration of more than 3 months
4. Individuals who can ambulate without assistive devices/ caretaker
5. Minimum educational level of 4th grade of elementary education
6. Individuals willing to participate
 
 
ExclusionCriteria 
Details  1. Individuals with no confirmatory diagnosis of knee OA
2. Individuals with known neuromuscular or musculoskeletal pathologies
3. Undergone total knee replacement, lumbar spine or any lower extremity surgery
4. Diagnosed with any health condition which could influence the function of foot such as
diabetes mellitus or any neurological or orthopaedic impairment
5. Individuals who do not give consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Toe Grip Strength  Only once 
 
Secondary Outcome  
Outcome  TimePoints 
Functional Reach Test  Once only 
Timed Up and Go Test  Once only 
Visual Analogue Test  Once only 
Western Ontario and McMaster University (WOMAC) OA index  Once only 
 
Target Sample Size   Total Sample Size="147"
Sample Size from India="147" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="92" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2024 
Date of Study Completion (India) 09/03/2024 
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)
Modification(s)  		 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  

This cross sectional study aims to determine the relationship between toe grip strength and dynamic balance and mobility in patients with knee osteoarthritis. 147 individuals between 45 to 65 years, diagnosed with knee osteoarthritis for a duration of more than 3 months will be recruited on basis of convenience sampling. The toe grip strength will be measured using the pinch gauge dynamometer. Dynamic balance and mobility will be assessed using the Functional Reach test and Timed Up & Go test respectively. An average of three trails will be recorded in a single session. The study will be conducted in a tertiary medical college hospital in Dakshina Kannada.

 
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