| CTRI Number |
CTRI/2024/12/078261 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Effectiveness Injury Prevention protocol with Education vs. Conventional Methods on Injury Rates, Awareness, and Performance in Adolescent Badminton Players with Early Sports Specialization |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of integrated injury prevention strategy along with education as against conventional approach on injury rate, parent and coach awareness, physical performance in adolescent badminton players with early sports specialization: A Randomized Controlled 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 |
Payal Vasant Dhawale |
| Designation |
Assistant Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Sports Physiotherapy, No.03, MGM Institute of Physiotherapy, N-6, CIDCO, Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
07276155645 |
| Fax |
|
| Email |
payaldhawale62@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Payal Vasant Dhawale |
| Designation |
Assistant Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Sports Physiotherapy, No.03, MGM Institute of Physiotherapy, N-6, CIDCO, Aurangabad
MAHARASHTRA
431001
India |
| Phone |
07276155645 |
| Fax |
|
| Email |
payaldhawale62@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Payal Vasant Dhawale |
| Designation |
Assistant Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Sports Physiotherapy, No.03, MGM Institute of Physiotherapy, N-6, CIDCO, Aurangabad
MAHARASHTRA
431001
India |
| Phone |
07276155645 |
| Fax |
|
| Email |
payaldhawale62@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Sports Physiotherapy, No.03, MGM Institute of Physiotherapy, N-6, CIDCO, Aurangabad |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy |
| Address |
Department of Sports Physiotherapy, No.03, MGM Institute of Physiotherapy, N-6, CIDCO, Aurangabad |
| 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 Payal Dhawale |
MGM Institute of Physiotherapy |
Department of Sports Physiotherapy, No.03, N-6, CIDCO, Aurangabad
Aurangabad
MAHARASHTRA |
07276155645
payaldhawale62@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Missions Ethics Committee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescent Badminton Players |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional training approach |
Conventional training will be training that athletes are doing on regular basis for injury prevention. |
| Intervention |
Integrated preventive strategy along with education |
Integrated preventive strategy along with education and therapist and coach supervised training, which is based on the principles of neuromuscular training and aims to enhance overall physical fitness and motor skill competencies to prevent sports-related injuries. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Both females and male’s adolescent badminton players, aged between 13 and 15 years.
2. Participating in organized badminton sports before reaching puberty (age 12 or younger) for a period of at least eight months annually.
|
|
| ExclusionCriteria |
| Details |
1. Any neurological impairment or psychological disorder impacting the health status.
2. Preexisting history of musculoskeletal injuries.
3. Occurrence of traumatic injury during the intervention period, requiring more than 8 days away from sport.
• Subject unwilling to participate and those who have not completed the duration of intervention
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of Injury, Incidence Proportion, Incidence Rate, Clinical Incidence, Coaches Awareness Questionnaire, Parent Awareness Questionnaire |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physical Fitness Assessment |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/02/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 a randomized controlled trial involving adolescent badminton players with early sports specialization. 230 Participants will be randomly assigned to either the integrated injury prevention strategy combined with education group or the conventional approach group. The study will be conducted over a period of six months, with measurements taken at baseline, and six months. The primary outcome measures will include injury rates, parental and coach awareness, and physical performance. |