| CTRI Number |
CTRI/2025/07/090320 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between BMI and core strength patients with knee osteoarthritis |
|
Scientific Title of Study
|
Correlation of BMI with core muscle strength in patients with knee osteoarthritis- a registry based 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 |
Dr Vanshika Matra |
| Designation |
postgraduate student |
| Affiliation |
DVVPFs college of Physiotherapy |
| Address |
department of musculoskeletal physiotherapy basement DVVPFS College of Physiotherapy, Opp. Govt. Milk Dairy, M.I.D.C., Vilad Ghat, Ahmadnagar - 414111
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9960303774 |
| Fax |
|
| Email |
vanshikamatra10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Saqib |
| Designation |
Associate professor |
| Affiliation |
DVVPFs college of Physiotherapy |
| Address |
department of musculoskeletal physiotherapy basement DVVPFS College of Physiotherapy, Opp. Govt. Milk Dairy, M.I.D.C., Vilad Ghat, Ahmadnagar - 414111
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
7517410984 |
| Fax |
|
| Email |
saqibpt@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanshika Matra |
| Designation |
postgraduate student |
| Affiliation |
DVVPFs college of Physiotherapy |
| Address |
department of musculoskeletal physiotherapy basement DVVPFS College of Physiotherapy, Opp. Govt. Milk Dairy, M.I.D.C., Vilad Ghat, Ahmadnagar - 414111
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9960303774 |
| Fax |
|
| Email |
vanshikamatra10@gmail.com |
|
|
Source of Monetary or Material Support
|
| DVVPFS College of Physiotherapy, Opp. Govt. Milk Dairy, M.I.D.C., Vilad Ghat, Ahmadnagar, Maharashtra India 414111 |
|
|
Primary Sponsor
|
| Name |
DVVPFs college of physiotherapy |
| Address |
Department of musculoskeletal physiotherapy Block 1 basement DVVPFs college of physiotherapy, Opp. Govt. Milk Dairy, M.I.D.C., Vilad Ghat, Ahilyanagar - 414111 |
| 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 Vanshika Matra |
DVVPFs college of Physiotherapy |
Department of musculoskeletal physiotherapy Opp Gov Milk Dairy MIDC Vilad Ghat Ahmadnagar 414111
Ahmadnagar
MAHARASHTRA |
9960303774
vanshikamatra10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFs college of physiotherapy Institutional ethical committee Ahmadnagar |
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients registered in knee OA registry.
Patients with confirmed knee OA (diagnosed vis clinical assessment and / or imaging)
|
|
| ExclusionCriteria |
| Details |
Patients having history of any trauma or surgery of lower extremity or back, lower extremity vascular disorders, neurological weakness of trunk and lower extremity.
Patients on prolonged non-steroidal anti-inflammatory drugs or corticosteroids therapy, pregnant subjects and those who underwent recent pregnancy (less than 1 year).
Patients with BMI less than 18.5 kg/m2.
Patients not having radiograph with them.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Body Mass Index |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pressure biofeedback apparatus |
baseline |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
20/08/2025 |
| 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)
|
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
|
This study is to see the correlation between BMI and core muscle strength in patients with knee osteoarthritis. Total number of participants will be 150. BMI values and core muscle strength values will be obtained from an online knee osteoarthritis registry. The obtained data will be analysed statistically and the relation between the above two parameters will be found. |