| CTRI Number |
CTRI/2024/03/064323 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation between muscle strength and knee joint space in people with knee osteoarthritis
|
|
Scientific Title of Study
|
Evaluation of association between repetitions of 30 seconds deep squat test and knee joint space width in individuals with knee osteoarthritis - 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 |
Shubham Shailesh Tawade |
| Designation |
Master Of Physiotherapy Student |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy, 2nd floor room No.227 MGM Hospital, Sector 1 Plot 1 and 2 Kamothe, Navi Mumbai Taluka Panvel
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
shubhamtawade@mgmsopnm.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajani Mullerpatan |
| Designation |
Professor Director |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy, 2nd floor room No. 227 MGM Hospital, Sector 1 Plot 1 and 2 Kamothe, Navi Mumbai Taluka Panvel
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
rajani.kanade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajani Mullerpatan |
| Designation |
Professor Director |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy, 2nd floor room No. 227 MGM Hospital, Sector 1 Plot 1 and 2 Kamothe, Navi Mumbai Taluka Panvel
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
rajani.kanade@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM School Of Physiotherapy MGM Institute of Health Sciences
MGM School of Physiotherapy MGM Institute of Health Sciences MGM Educational Campus Sector 1 Plot 1 and 2 Kamothe Navi Mumbai Navi Mumbai Taluka Panvel District Raigad |
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences MGM Educational Campus Sector 1 Plot 1 and 2 Kamothe Navi Mumbai Navi Mumbai Taluka Panvel District Raigad |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajani Mullerpatan |
MGM School of Physiotherapy MGM Institute of Health Sciences |
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy, 2nd floor room no. 227 MGM Hospital, Sector 1 Plot 1 and 2 Kamothe, Navi Mumbai Taluka Panvel Raigad MAHARASHTRA 410209
Raigarh
MAHARASHTRA |
02227437866
rajani.kanade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mahatma Gandhi Missions Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Individuals in the age group of 40 to 65 years with diagnosed knee osteoarthritis on knee radiograph
Individuals with unilateral and bilateral knee osteoarthritis
Individuals with grade one to three knee osteoarthritis on kallegren Lawrence Scale |
|
| ExclusionCriteria |
| Details |
People with known meniscal or ligament injury deformity lower limb fractures in past 1 year other degenerative and autoimmune disorders
Individuals with acute exacerbation of symptoms like moderate to extreme pain of 6 out of 10 on numerical rating pain scale and presence of warmth
Osteoarthritis of spine and low back pain
Arthropathic psoriasis
People with uncontrolled hypertension and resting blood pressure more than 150 by 90mmhg
People with cognitive issues that prevented comprehension of instructions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
knee joint space width
Thirty seconds deep squat test repetitions
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.knee range of motion
2.lower extremity muscle strength
3.kinetics, kinematics, muscle activity & spatiotemporal variables during activities walking, sit to stand, step down activity & deep squatting.
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
28/03/2024 |
| 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="0"
Months="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Knee osteoarthritis is a leading cause of pain, disability and dysfunction leading to poor quality of life and level of functioning. Early identification and management of Knee osteoarthritis may enable to delay in functional decline and disease burden. This cross-sectional study aims to investigate the association between 30-second deep squat test repetitions and knee joint space width in individuals with diagnosed Knee osteoarthritis, proposing it as a clinical tool for early Knee osteoarthritis identification. The study will enhance our understanding of the link between functional performance and radiological changes in Knee osteoarthritis. It will enhances clinical assessments, offering a cost-effective and simple tool for detecting Knee osteoarthritis progression. |