| CTRI Number |
CTRI/2025/03/081564 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Sports science] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of strength, neuromuscular, and jump training on lower leg movement during landing
|
|
Scientific Title of Study
|
Effect of Strength, Plyometric, and Neuromuscular Training on Tibial
Acceleration During Landing in Recreational Athletes: 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 |
Parvez Khan |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Exercise and Sport Sciences, Manipal College of
Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9528101670 |
| Fax |
|
| Email |
parvezkhanhussain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Baskaran Chandrasekaran |
| Designation |
Assistant Professor – Selection grade |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Exercise and Sport Sciences, Manipal College of
Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
7639280751 |
| Fax |
|
| Email |
baskaran.c@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Baskaran Chandrasekaran |
| Designation |
Assistant Professor – Selection grade |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Exercise and Sport Sciences, Manipal College of
Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
7639280751 |
| Fax |
|
| Email |
baskaran.c@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Exercise and Sport Sciences, Manipal College of Health Professions, MAHE,
Manipal, Udupi, Karnataka, India - 576104 |
|
|
Primary Sponsor
|
| Name |
Parvez Khan |
| Address |
Department of Exercise and Sport Sciences, Manipal College of
Health Professions, MAHE, Manipal, Udupi, Karnataka, India -
576104
|
| 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 |
| Baskaran Chandrasekaran |
Marena Sports Complex, MAHE |
Marena Rd, Madhav
Nagar, Eshwar Nagar,
MAHE, Manipal -
576104
Udupi
KARNATAKA
Udupi
KARNATAKA |
7639280751
baskaran.c@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Recreational landing dominant sports athletes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
In the control group, the participants will not be provided with the interventional plan (strength, neuromuscular, and plyometric training), and they will be allowed to continue with their routine type of training without no new training regime planned for next four weeks |
| Intervention |
Strength, Plyometric, and Neuromuscular Training |
The intervention group will be provided with strength, neuromuscular, and plyometric training for a total of 4 weeks, which is thrice a week, leading to a total of 12 supervised sessions. Each session will be individualized based on the participants training status and exertion levels. Total duration of each session is 45 minutes per day, three days a week and four weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Sports in which landing is performed often (football, basketball, volleyball, badminton).
Recreational athletes: train or play any of the above-mentioned sports for at least 3 days/week.
|
|
| ExclusionCriteria |
| Details |
Any acute injury in past 2 weeks that can hinder sprinting performance (e.g.- fractures, ligament sprains, muscle strains, tendon injuries, nerve injuries etc.)
History of lower limb and spinal surgery in last 1 year.
History of any chronic instability (knee or ankle or hip) in last 1 year.
History of any cardiovascular disease (heart attack, hypertension, stroke, coronary artery disease, arrhythmia, diabetes etc.)
Not enrolled for any other ongoing study or any recent study which could have possible training fatigue.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tibial Acceleration using Inertial
Measurement Unit (IMU)
Sensors |
0th week (before trial) and 4th week (after trial) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
13/03/2025 |
| Date of Study Completion (India) |
25/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/04/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Purpose of the study: To look at the efficacy of strength, neuromuscular and plyometric training on tibial acceleration during landing movement (to see if there is any improvement in knee movement quality). Need of the Study: This study is needed to reduce the literature gap regarding strength, neuromuscular, and plyometric training programs in preventing ACL injury for landing activities. Also, it will help athletic trainers, coaches, therapists, etc., understand the ACL injury prevention plans with respect to knee health and quality of movement. The study will recruit 58 participants. All participants meeting the criteria will be screened with a 31cm Drop Vertical Jump test using Inertial Measurement Unit (IMU) sensors for both pre and post-test tibial acceleration. The intervention group participants will receive strength, neuromuscular, and plyometric training, and for the control group, a diary log will be taken regarding their training. No. of patients expected to participate is 58. Participants will be screened regarding their training history and previous injuries. The participants will be categorized into 2 groups using block randomization, control and intervention groups. The intervention will be given for 4 weeks. 3 weekly training sessions will be provided. |