| CTRI Number |
CTRI/2025/09/094460 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| 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
|
use of exercise program for improving performance and reduce injuries in young female aerobic gymnasts.
|
|
Scientific Title of Study
|
Feasibility of Integrated Neuromuscular Training on Functional
Performance and Rate of Injury in Young Female Aerobic Gymnasts – A
Pilot 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 |
Swarnima Dhote |
| Designation |
PG Student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of sports physiotherapy, no-03, MGM Institute of Physiotherapy, N-6,CIDCO,Aurangabad, 431003 N-6,CIDCO,Aurangabad, 431003 Aurangabad MAHARASHTRA 431001 India |
| Phone |
7387327822 |
| Fax |
|
| Email |
swarnima9dhote@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Payal Dhawale |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Sports Physiotherapy, No.3, N-6, CIDCO, Aurangabad, Maharashtra N-6,CIDCO,Aurangabad, 431003 Aurangabad MAHARASHTRA 431003 India |
| Phone |
7276155645 |
| Fax |
|
| Email |
payaldhawale62@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Swarnima Dhote |
| Designation |
PG Student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Sports Physiotherapy, No.3, N-6, CIDCO, Aurangabad, Maharashtra N-6,CIDCO,Aurangabad, 431003 Aurangabad MAHARASHTRA 431001 India |
| Phone |
7387327822 |
| Fax |
|
| Email |
swarnima9dhote@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Sports Physiotherapy, No.3, MGM Institute of Physiotherapy,N-6,CIDCO,Aurangabad |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy |
| Address |
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 |
| Swarnima Dhote |
MGM Institute of Physiotherapy |
Department of Sports Physiotherapy, No.3,N-6,CIDCO,Aurangabad Aurangabad MAHARASHTRA |
07387327822
swarnima9dhote@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM-ECRHS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Aerobic gymnasts at risk of injury. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated Neuromuscular Training and routine gymnastics training |
The INT protocol includes strength training (e.g., resistance band exercises, planks), plyometric drills (e.g., squat jumps, box jumps, skipping), and agility drills (e.g., T-drill, zigzag runs), progressing weekly in intensity and complexity along with routine gymnastics training will be given twice a week for 30-45 mins per session for 8 weeks. |
| Comparator Agent |
Routine gymnastics training
|
Routine gymnastics training will include general warm up and pre training exercises for 30-40 mins for 5-6 days a week for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Female |
| Details |
Minimum 1 year of competitive aerobic gymnastics experience (Any level) |
|
| ExclusionCriteria |
| Details |
1.Musculoskeletal Injuries in past 6 months -1 year
2.Existing symptoms from previous musculoskeletal injuries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| GFMT(Gymnastics Fucntional Measurement Tool) |
Pre and post intervention(8 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rate of injury |
Post 6 months from the start of intervention. |
| Satisfaction and acceptability questionnaire |
After the end of intervention( after 8 weeks) |
|
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
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 3 |
|
Date of First Enrollment (India)
|
10/12/2025 |
| 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 pilot randomized controlled trial evaluates the feasibility and effectiveness of an 8-week Integrated Neuromuscular Training (INT) program on functional performance and injury rate in young female aerobic gymnasts aged 9–16 years. The written and oral consent from the parents and assent form from the participants will be taken and procedure will be explained. Demographic data will be noted. Baseline data which will include functional performance and rate of injury will be assessed. Participants (n=24) will be randomized into two groups: an experimental group receiving INT with routine gymnastics training and a control group receiving routine gymnastics training. The INT protocol includes strength training (e.g., resistance band exercises, planks), plyometric drills (e.g., squat jumps, box jumps, skipping), and agility drills (e.g., T-drill, zigzag runs), progressing weekly in intensity and complexity will be given twice a week for 30-45 mins per session for 8 weeks. Routine gymnastics training will include general warm up and pre training exercises for 30-40 mins for 5-6 days a week for 8 weeks. Functional performance will be measured using the Gymnastics Functional Measurement Tool (GFMT) pre and post intervention period, and injury incidence will be recorded per 1000 training hours. Feasibility will be assessed based on enrolment, adherence, retention, and satisfaction (via satisfaction and acceptability questionnaire) . Statistical analysis of the collected data will be done. This study will provide insight into integrating INT into gymnastics programs to improve performance and reduce injury risk. Conclusion will be established on the based on the obtained results of the study. |