| CTRI Number |
CTRI/2025/02/081120 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An interventional study to check the effect of injury prevention program in soccer goalkeepers |
|
Scientific Title of Study
|
Effect of FIFA 11+ shoulder injury prevention program on eccentric rotator cuff strength core stability and shoulder stability in soccer goalkeepers |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikhil Kumar |
| Designation |
PG Student MPT-S |
| Affiliation |
Indian Spinal Injuries Center-Institute Of Rehabilitation Sciences |
| Address |
2nd floor sports lab, Indian Spinal Injuries Center-Institute Of Rehabilitation Sciences Sector-C Vasant Kunj 2nd floor sports lab, Indian Spinal Injuries Center-Institute Of Rehabilitation Sciences Sector-C Vasant Kunj South DELHI 110070 India |
| Phone |
8076587710 |
| Fax |
|
| Email |
nikhilmax02@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sadhan Berry PT |
| Designation |
Associate professor |
| Affiliation |
Indian Spinal Injuries Center-Institute Of Rehabilitation Sciences |
| Address |
2nd floor sports lab, Indian Spinal Injuries Center-Institute Of Rehabilitation Sciences Sector-C Vasant Kunj 2nd floor sports lab, Indian Spinal Injuries Center-Institute Of Rehabilitation Sciences Sector-C Vasant Kunj South DELHI 110070 India |
| Phone |
9818098441 |
| Fax |
|
| Email |
Sadhan27@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sadhan Berry PT |
| Designation |
Associate professor |
| Affiliation |
Indian Spinal Injuries Center-Institute Of Rehabilitation Sciences |
| Address |
2nd floor sports lab, Indian Spinal Injuries Center-Institute Of Rehabilitation Sciences Sector-C Vasant Kunj 2nd floor sports lab, Indian Spinal Injuries Center-Institute Of Rehabilitation Sciences Sector-C Vasant Kunj South DELHI 110070 India |
| Phone |
9818098441 |
| Fax |
|
| Email |
sadhan27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Center-Institute Of Rehabilitation Sciences Sector-C Vasant Kunj New Delhi- 110070 |
|
|
Primary Sponsor
|
| Name |
Indian Spinal Injuries Center-Institute Of Rehabilitation Sciences |
| Address |
Sector-C ,Vasant Kunj, New Delhi- 110070 |
| Type of Sponsor |
Other [Self] |
|
|
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 Nikhil Kumar |
Strykers Sports Academy |
Ground floor football ground, Govt. Sarvodaya Kanya Vidyalaya Shahbad Mohd.pur Dwarka New Delhi DELHI |
8076587710
nikhilmax02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indian Spinal Injuries Center- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sports Athletes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional warm-up program (Group B) |
conventional warm-up program |
| Intervention |
FIFA 11+ Shoulder Injury Prevention Program (Group A) |
FIFA 11+ Shoulder injury prevention program given for 3 sessions per week ,a total of 24 sessions over 8 weeks.
FIFA 11+ Shoulder injury prevention program takes 20-25 minutes to complete and replaces the usual warm-up before training |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Both Male and Female Soccer Goalkeeper
2. Age Group 18-35 years
3. Previous soccer experience must be at least 2 years
4. Playing at least 3 training sessions weekly |
|
| ExclusionCriteria |
| Details |
1. Any medical history of upper extremity injury in the past 6 months
2. Athletes underwent any major surgery on the shoulder or any upper extremity bone fracture in the previous year
3. Any diagnosed cardiovascular or neurological disorder
4. Should not participate in any other rehabilitation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Shoulder stability |
At the baseline and at the end of 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Eccentric rotator cuff strength |
At the baseline and at the end of 8th week |
| Core Stability |
At the baseline and at the end of 8th week |
|
|
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)
|
03/03/2025 |
| 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="6" 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
|
The study examines the effects of the FIFA 11+ Shoulder Injury Prevention Program on eccentric rotator cuff strength, core stability, and shoulder stability in soccer goalkeepers, who are particularly susceptible to shoulder injuries due to frequent upper limb usage. The program aims to improve shoulder strength and reduce injury rates, addressing the higher incidence of shoulder injuries among goalkeepers compared to outfield players.The research employs a pre- and post-experimental design with a sample of 30 goalkeepers (15 in each group) between ages 18-35, with at least two years of experience and regular training sessions. Participants with recent upper extremity injuries, major surgeries, or neurological/cardiovascular disorders were excluded. The study used tools like the handheld dynamometer, the Close Kinetic Chain Upper Extremity Stability Test (CKCUEST), and the Unilateral Hip Bridge Endurance (UHBE) test to measure outcomes.Data analysis involves descriptive statistics, t-tests, or non-parametric tests based on normality, assessed via the Shapiro-Wilk test. For normally distributed data, an independent t-test and paired t-test are planned to compare mean differences between the FIFA 11+ program group and a control group. For skewed data, the Mann-Whitney U-test and Wilcoxon signed rank test will be used. Results will be analyzed with SPSS software, with significance set at a 5% alpha level. The study hypothesizes that the program will significantly enhance eccentric rotator cuff strength, core stability, and shoulder stability in soccer goalkeepers. |