| CTRI Number |
CTRI/2024/03/064132 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Leg angulation and patella (knee cap) mobility in general population |
|
Scientific Title of Study
|
Correlation of Q angle and patellar mobility in asymptomatic individuals |
| 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 Hariharasudhan Ravichandran |
| Designation |
Professor |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Department of Physiotherapy
Alvas College of Physiotherapy and Research Centre, Moodbidri, DK
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9789906015 |
| Fax |
|
| Email |
hrkums63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Hariharasudhan Ravichandran |
| Designation |
Professor |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Department of Physiotherapy
Alvas College of Physiotherapy and Research Centre, Moodbidri, DK
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9789906015 |
| Fax |
|
| Email |
hrkums63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms. Tejaswini |
| Designation |
Professor |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Department of Physiotherapy
Alvas College of Physiotherapy and Research Centre, Moodbidri, DK
Department of Physiotherapy
Alvas College of Physiotherapy and Research Centre, Moodbidri, DK
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9789906015 |
| Fax |
|
| Email |
therapistpark@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Alvas College of Physiotherapy and Research Centre |
| Address |
Outpatient Physiotherapy department, Alvas Health Center complex, Moodbidri, DK, Karnataka |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Hariharasudhan Ravichandran |
Alvas Health Center |
Outpatient Department of Physiotherapy
Alvas health center, Moodbidri, DK
Dakshina Kannada
KARNATAKA |
9789906015
hrkums63@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Alvas College of Physiotherapy and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Asymptomatic |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Asymptomatic individuals
Willingness to participate |
|
| ExclusionCriteria |
| Details |
History of anterior knee pain or any lower limb pathologies
History of immobilization or gait disturbances
History of congenital deformities and neurological conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Q angle
Patellar mobility |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
none |
|
|
Target Sample Size
|
Total Sample Size="133"
Sample Size from India="133"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
25/03/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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 study is intended to analyse the q angle of individuals and correlate it with patellar mobility, inorder to identify whether q angle and patellar mobility are related in general individuals. The study result will identify the etiology of patellar mobility. |