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CTRI Number  CTRI/2023/08/056650 [Registered on: 18/08/2023] Trial Registered Prospectively
Last Modified On: 10/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   in healthy and obese patients with knee OA, a relationship study between core muscle strength, rectus femoris flexibility and quadriceps strength 
Scientific Title of Study   A correlation study of core muscles strength with rectus femoris flexibility and quadriceps strength in normal and obese patients with knee osteoarthritis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manalisa kalita 
Designation  MPT student 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and rehabilitation 
Address  Maharishi Markandeshwar Institute of Physiotherapy and rehabilitation, Maharishi Markandeshwar(Deemed to be university),Mullana Ambala,Hryana

Ambala
HARYANA
133207
India 
Phone  8753931655  
Fax    
Email  manalisakalita5147@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sunita Sharma  
Designation  Associate Professor 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and rehabilitation 
Address  Maharishi Markandeshwar Institute of Physiotherapy and rehabilitation, Maharishi Markandeshwar(Deemed to be university),Mullana-Ambala,Hryana

Ambala
HARYANA
133207
India 
Phone  9467633734  
Fax    
Email  drsunita.sharma@mmumullana.org  
 
Details of Contact Person
Public Query
 
Name  Sunita Sharma  
Designation  Associate Professor 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and rehabilitation 
Address  Maharishi Markandeshwar Institute of Physiotherapy and rehabilitation, Maharishi Markandeshwar(Deemed to be university),Mullana-Ambala,Hryana

Ambala
HARYANA
133207
India 
Phone  9467633734  
Fax    
Email  drsunita.sharma@mmumullana.org  
 
Source of Monetary or Material Support  
Orthopaedic Physiotherapy research lab, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be university), Mullana, Ambala, Haryana 
 
Primary Sponsor  
Name  Manalisa kalita  
Address  Maharishi Markandeshwar Institute of Physiotherapy and rehabilitation, Maharishi Markandeshwar(Deemed to be university),Mullana-Ambala,Haryana 
Type of Sponsor  Other [self] 
 
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 
Manalisa Kalita  Maharishi Markandeshwar superspeciality hospital  Maharishi Markandeshwar Institute of Physiotherapy and rehabilitation, Maharishi Markandeshwar(Deemed to be university),Mullana-Ambala, Haryana
Ambala
HARYANA 
08753931655

manalisakalita5147@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee M.M Institute of medical science and research, Mullana(Ambala)   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 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients who have taken physiotherapy treatment and no physiotherapy treatment both will be included.
pain should be at least 30mm on 100mm VAS.
knee pain in at least one limb should be provoked by running, walking, hoping, squatting.
Knee OA grade 2 and grade 3 
 
ExclusionCriteria 
Details  Lower extremity injuries or fractures
Complain of LBP, Hip, ankle, or foot pain
History of surgery of lower extremity
unable to ambulate independently with or without an assistive device
pregnant subject and those who underwent recent pregnancy
patient with a metabolic disorder like diabetes mellitus 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•Core muscle strength: Pressure Biofeedback Unit
•Quadriceps flexibility: Ely’s Test

 
baseline 
 
Secondary Outcome  
Outcome  TimePoints 
•Quadriceps strength: Isokinetic Dynamometer
•Visual Analogue scale (VAS)
 
baseline 
 
Target Sample Size   Total Sample Size="77"
Sample Size from India="77" 
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)   25/08/2023 
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="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  

Background: Most people with increasing age are suffering from different kinds of joint diseases, among them, Osteoarthritis (OA) is the most common one, which is a clinical condition of joint pain and dysfunction brought on by joint deterioration. The knee is the most prevalent location for OA, even though various lower extremity joints, including the ankle and hip, may be affected. OA raises the risk of morbidity and death, causes pain and disability, and lowers the quality of life. Increased age and Body Mass Index (BMI) is the most common risk factor for developing knee Osteoarthritis (knee OA), and also females are more prone to develop knee OA. It has been proven that exercising regularly can lessen the discomfort caused by knee OA.

Aim:  The aim of the study is to find the relation between core muscle strength with rectus femoris flexibility and quadriceps strength in obese and non-obese patients with knee OA.

Methodology: Obese and non-obese participants aged 40 to 70 will be recruited according to knee OA grade 2 and 3. The demographic data of the participants will be allocated to the obese and non-obese groups. Then the participants will be assessed for core muscle strength, rectus femoris flexibility, and quadriceps strength and the data obtained will be compared for both groups. Outcome measures like Pressure Biofeedback Unit, Isokinetic Dynamometer, Ely’s Test, and Visual Analogue Scale (VAS) will be used for the assessment.

Data analysis: Kolmogorov-Smirnov test will be applied to check normality. If the data is found to be normally distributed, the independent t-test will be used between groups. If the data is not found to be normally distributed, then the Mann-Whitney U test will be used.

Keywords: Core muscle strength, knee osteoarthritis, Obese and non-obese, Rectus femoris flexibility, Quadriceps strength 
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