| CTRI Number |
CTRI/2025/07/090480 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study Comparing Muscle Activity Around the Knee in College Athletes With and Without Kneecap Movement Problems |
|
Scientific Title of Study
|
Comparison of Vastus Medialis and Vastus Lateralis muscle activity in collegiate players with and without Altered Patellar Tracking |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pavan Kartheek |
| Designation |
Postgraduate Student - MPT |
| Affiliation |
Manipal College of Health Professions- Manipal Academy of Higher Education. |
| Address |
Department of Physiotherapy, room no.: 215, second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, KARNATAKA, India- 576104
Udupi KARNATAKA 576104 India |
| Phone |
9494330570 |
| Fax |
|
| Email |
pavan.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Mr Ganesh Balthillaya |
| Designation |
Assistant Professor( Selection Grade) |
| Affiliation |
Manipal College of Health Professions- Manipal Academy of Higher Education. |
| Address |
Department of Physiotherapy, room no.: 215, second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, KARNATAKA, India- 576104
Udupi KARNATAKA 576104 India |
| Phone |
9448263631 |
| Fax |
|
| Email |
Ganesh.bm@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Mr Ganesh Balthillaya |
| Designation |
Assistant Professor( Selection Grade) |
| Affiliation |
Manipal College of Health Professions- Manipal Academy of Higher Education. |
| Address |
Department of Physiotherapy, room no.: 215, second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, KARNATAKA, India- 576104
Udupi KARNATAKA 576104 India |
| Phone |
9448263631 |
| Fax |
|
| Email |
Ganesh.bm@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India 576104 |
|
|
Primary Sponsor
|
| Name |
Pavan Kartheek |
| Address |
Department of Physiotherapy, room no.: 215, second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, KARNATAKA, India- 576104
Udupi
KARNATAKA
576104
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pavan Kartheek |
Kasturba Hospital |
Department of Physiotherapy, N1, First floor, Artificial Limb Centre, Baliga Block, Kasturba Hospital, Udupi- Hebri Road, Madhava Nagar, Manipal, Udupi, Karnataka 576104 Udupi KARNATAKA |
9494330570
pavan.mchpmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Altered Patellar Tracking |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Presence of J sign.
Outdoor games collegiate players. |
|
| ExclusionCriteria |
| Details |
Any pain in the lower extremities.
History of surgery in the lower extremity in the past six months at the time of assessment.
Low back pain. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of Muscle Activity (%MVIC) of Vastus Medialis and Vastus Lateralis |
Single time point (during exercise performance at baseline) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="38" Sample Size from India="38"
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)
|
01/08/2025 |
| 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="0" Months="9" 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 will be based on the evaluation of the electrical activity of the Vastus Medialis and Vastus Lateralis muscles using surface electromyography in collegiate athletes with and without altered patellar tracking. Participants will undergo clinical screening using the J sign and then be divided into two groups: one with altered patellar tracking and the other with normal patellar tracking. Muscle activity will be recorded during functional tasks such as single-leg squat, traditional split squat, forward step-up, and lateral step-up. This observational study aims to identify differences in muscle activation patterns that may be associated with patellar maltracking and contribute to the development of effective physiotherapy rehabilitation strategies in athletic populations. |