| CTRI Number |
CTRI/2025/04/084496 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
How Comprehensive Exercise Program Affects Speed, Pain, Performance, and Balance in Athletes with Knee Pain |
|
Scientific Title of Study
|
Effects of Comprehensive Exercise Protocol on Pace, Pain, Performance and Balance in Athletes with Patellofemoral Pain Syndrome |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suraj Barwal |
| Designation |
MPT Student |
| Affiliation |
Gurugram University |
| Address |
Gurugram University, Sector-87, Gurugram,122505
Gurugram University, Sector-87, Gurugram,122505
Gurgaon
HARYANA
122505
India |
| Phone |
7683063017 |
| Fax |
|
| Email |
surajbarwal13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR T KARTHIKEYAN |
| Designation |
Associate Professor |
| Affiliation |
Gurugram University |
| Address |
Gurugram University, Sector-87, Gurugram
Gurgaon
HARYANA
122005
India |
| Phone |
9448343356 |
| Fax |
|
| Email |
drkarthiknimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suraj Barwal |
| Designation |
MPT Student |
| Affiliation |
Gurugram University |
| Address |
Gurugram University, Sector-87, Gurugram
Gurgaon
HARYANA
122005
India |
| Phone |
7683063017 |
| Fax |
|
| Email |
surajbarwal13@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Gurugram University |
| Address |
Gurugram University, Sector-87, Gurugram |
| Type of Sponsor |
Research institution |
|
|
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 |
| Sunil Bhardwaj |
Tau Devi Lal Stadium |
Physiotherapy room 07,Sector-38, Gurugram
Gurgaon
HARYANA |
9459756918
nag.sharma18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of Department of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patellofemoral Pain Syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Exercise Protocol |
Athletes are selected according to the inclusion criteria and informed written consent will be taken from all participants.
The individuals will be diagnosed based on the patellar grind test (Clarke’s sign). The patellar grind test or Clarkes sign determines if patellofemoral dysfunction is present. The subject will be lying on their back or long sitting with the affected knee extended. The therapist applies pressure while placing hands web space above the patella. The quadriceps muscle was contracted gradually and softly by the subject. Pain in the PFJ was the positive indicator for this test.
Group Control
Group CG – Conventional Exercise Protocol (3 times a week )
Pre experimental assessment is taken Numeric Pain Rating Scale (NPRS), Performance, Pace and balance is measured.
Exercise protocol is given 3 times a week for 4 weeks (12 sessions). A 10 min warm up and cool down exercise session is also given with each session. [
|
| Intervention |
Group EG – Conventional Exercise Protocol + Comprehensive exercise protocol |
Athletes are selected according to the inclusion criteria and informed written consent will be taken from all participants.
The individuals will be diagnosed based on the patellar grind test (Clarke’s sign). The patellar grind test or Clarkes sign determines if patellofemoral dysfunction is present. The subject will be lying on their back or long sitting with the affected knee extended. The therapist applies pressure while placing hands web space above the patella. The quadriceps muscle was contracted gradually and softly by the subject. Pain in the PFJ was the positive indicator for this test.
Group Experimental Group
Group EG – Conventional Exercise Protocol + Comprehensive exercise protocol
Pre experimental assessment is taken Numeric Pain Rating Scale (NPRS), Performance, Pace and balance is measured.
Exercise protocol is given 3 times a week for 4 weeks (12 sessions). A 10 min warm up and cool down exercise session is also given with each session.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
Male Track Event Athletes.
Subjects with age between 18 to 30 years.
Those subjects who have Patellofemoral Pain Syndrome from at least 3 months before to the study.
Those subjects who have NPRS score above 3 /10. |
|
| ExclusionCriteria |
| Details |
Subjects involved in any other study.
Subjects with any other past medical history involving lower- extremity or back surgery.
Subjects with any other history of Neurological, cardiovascular or any other medical conditions that would interfere in the participation in the study.
Subjects not willing to participate.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain - Numeric Pain Rating Scale (NPRS).
Pace – 20 meter sprint.
Performance - Anteromedial lunge test.
Step-down test.
Balance - The modified Star Excursion Balance Test(mSEBT) |
Pre & Post |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/04/2025 |
| 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="2"
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
|
Athletes are selected according to the inclusion criteria and informed written consent will be taken from all participants. The individuals will be diagnosed based on the patellar grind test (Clarke’s sign). The patellar grind test or Clarke’s sign determines if patellofemoral dysfunction is present. The subject will be lying on their back or long sitting with the affected knee extended. The therapist applies pressure while placing hand’s web space above the patella. The quadriceps muscle was contracted gradually and softly by the subject. Pain in the PFJ was the positive indicator for this test.
They are divided into Group Control Group & Group Experimental Group Group CG – Conventional Exercise Protocol (3 times a week ) Group EG – Conventional Exercise Protocol + Comprehensive exercise protocol Pre experimental assessment is taken Numeric Pain Rating Scale (NPRS), Performance, Pace and balance is measured. Exercise protocol is given 3 times a week for 4 weeks (12 sessions). A 10 min warm up and cool down exercise session is also given with each session. |