| CTRI Number |
CTRI/2025/08/092253 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of a multiplanar core stability training program on squat movement pattern and knee control in college athletes using video-based analysis |
|
Scientific Title of Study
|
Influence of a multiplanar lumbopelvic stability program on overhead deep squat pattern and dynamic knee valgus in collegiate athletes by using 2d kinematic analysis. A randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srinivasulu M |
| Designation |
PhD Scholar |
| Affiliation |
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences |
| Address |
5th floor, Health Science block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai
Kancheepuram TAMIL NADU 602105 India |
| Phone |
8123477108 |
| Fax |
|
| Email |
srinuphysio88@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Kamalakannan M |
| Designation |
Professor and Guide |
| Affiliation |
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences |
| Address |
5th floor, Health Science block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai
Kancheepuram TAMIL NADU 602105 India |
| Phone |
9600004487 |
| Fax |
|
| Email |
kamal1712@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Kamalakannan M |
| Designation |
Professor and Guide |
| Affiliation |
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences |
| Address |
5th floor, Health Science block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai
Kancheepuram TAMIL NADU 602105 India |
| Phone |
9600004487 |
| Fax |
|
| Email |
kamal1712@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vydehi Institute of Physiotherapy, Vydehi Group of Institutions.
No. 82, EPIP Area, Nallurahalli, Whitefield, Bangalore, KARNATAKA 560066, INDIA |
|
|
Primary Sponsor
|
| Name |
Vydehi Institute of Physiotherapy, Vydehi Group of Institutions |
| Address |
No. 82, EPIP Area, Nallurahalli, Whitefield, Bangalore, KARNATAKA |
| 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 |
| Srinivasulu M |
Vydehi Institute of Physiotherapy |
Room No. 14, Ground floor, Physiotherapy block, Vydehi Institute of Physiotherapy, Vydehi Institute of Medical Sciences and Research Centre, EPIP Area, Nallurahalli, Whitefield, Bangalore, 560066 Bangalore KARNATAKA |
8123477108
srinuphysio88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vydehi Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M990||Segmental and somatic dysfunction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Core stability program |
45 mins per session, four sessions per week, a total of 16 sessions |
| Intervention |
Multiplanar Lumbopelvic Stability Program |
45 mins per session, four sessions per week, a total of 16 sessions. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Male |
| Details |
Male subjects are included
Age between 17 years and 25 years
Males who play recreational volleyball, basketball, and Football and playing on average 2 times or less than that in a week
Subjects with poor lumbopelvic control with positive findings of the following procedures: Knee Lift Abdominal Test, Bend Knee Fall-Out, Active Straight Leg Raising and PRONE Test by using Pressure Biofeedback Unit. |
|
| ExclusionCriteria |
| Details |
Age less than 17 years or more than 25 years
History of Low back injury or severe lower extremity injuries within the previous 6 months
Any known neuromuscular disorders and any other systemic disorders
Unwillingness of the participant. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Unilateral Hip Bridge Endurance Test
Landing Error Scoring System
Deep Overhead Squat Test
Frontal Plane Projection Angle |
Baseline, 4 weeks and 16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
01/09/2025 |
| 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 double-blinded randomized controlled trial aims to assess the effectiveness of the multiplanar lumbopelvic stability program and the traditional core stability program. Lumbopelvic stability is essential for injury prevention and performance in dynamic movements like deep squats, and dynamic knee valgus, the inward collapse of the knee, poses injury risks.
Participants will be randomly allocated into two groups: Group A will receive the multiplanar lumbopelvic stability program along with conventional core stability training, and Group B will receive only conventional core stability training. Both interventions will be administered as four exercise sessions for a week, a total of 16 sessions. Each session will follow standardized parameters and treatment duration under the supervision of a trained physiotherapist. These interventions are safe, noninvasive, drug-free, and simple to administer, with minimal to no side effects, making them suitable for routine clinical use.
The study population will be recruited based on the selection criteria.
The following outcome measures will be assessed: Unilateral Hip Bridge Endurance Test, Landing Error Scoring System, Deep Overhead Squat Test, Frontal Plane Projection Angle. A basic musculoskeletal physiotherapy assessment will be carried out before intervention. Outcome assessments will be conducted across three timelines: one at baseline, a second at the completion of 4 weeks, and a third at the 16th week to evaluate the treatment effects.
All participants will receive a participant information sheet that clearly outlines the study’s purpose, procedures, potential benefits, and risks. Written informed consent will be obtained prior to participation, ensuring full understanding, confidentiality, and voluntary involvement. Participants may withdraw from the study at any point without penalty.
This trial aims to assess the effectiveness of the Multiplanar Lumbopelvic Stability Program in influencing the overhead deep squat pattern and addressing dynamic knee valgus among collegiate athletes, which can provide valuable insights into the impact of the intervention on biomechanics, ultimately contributing to the optimization of training protocols, reduction of injury risks, and promotion of long-term musculoskeletal health in collegiate sports. |