| CTRI Number |
CTRI/2025/03/083393 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Preventing Injuries in Handball Players |
|
Scientific Title of Study
|
Preventing Injuries and Optimizing Performance in Handball Players: 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 |
Rajeev |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
6283068476 |
| Fax |
|
| Email |
rajeevthakur302@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Charu Gera |
| Designation |
Assistant professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9467940405 |
| Fax |
|
| Email |
charugera321@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Charu Gera |
| Designation |
Assistant professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9467940405 |
| Fax |
|
| Email |
charugera321@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajeev MPT Student Department of Physiotherapy Guru Jambheshwar
University of Science and Technology Hisar Haryana India 125001 |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Guru Jambheshwar University of Science and Technology Hisar
Haryana India 125001 |
| 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 |
| Dr Charu Gera |
Guru Jambheshwar University of Science and Technology |
Room No 05 Department of Physiotherapy OPD GJUS&T Hisar HARYANA
Hisar
HARYANA |
9467940405
charugera321@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of GJUS&T |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
handball players |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Preparatory Exercises |
Patients in this group will perform preparatory Exercises for three sessions per week for six weeks |
| Intervention |
Preparatory Exercises and Ballistic Exercises |
Patients in this group will perform Preparatory Exercises and Ballistic Exercises for three sessions per week for six weeks |
| Intervention |
Preparatory Exercises and Theraband Exercises |
Patients in this group will perform Preparatory Exercises and Theraband Exercises three sessions per week for six weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
Subjects with the age group between 18-30 years old will be included in the study
Male handball players
Players who played at least state or national’s level
Players having an experience of more than 2 year |
|
| ExclusionCriteria |
| Details |
Age below 18 and more than 30 should be excluded
Recent injuries within 6 months like fracture, dislocation, neurological injuries
Players having any history of psychiatric neurological, cardiovascular or respiratory
disorder
Participants who do not cooperate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stability (closed kinetic chain upper extremity stability test)
Coordination (plate-tapping test)
Speed (plate-tapping test)
Agility (agility T-test)
power (vertical jump)
Strength (sitting medicine ball throw test)
|
The outcome will be assess for three times which is at the baseline, third week and after the six week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of motion (goniometer) |
The outcome will be assess for three times which is at the baseline, third week & after the six week |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
04/04/2025 |
| 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="1"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
It is a randomized controlled trial with a duration of 6 weeks and involving 45 patients that will be divided into three groups based on the lottery method. Its
intervention involves preparatory and ballistic exercises in one
group and preparatory and theraband exercises in second group and preparatory exercises in third group. The patients will be
informed about the study and written informed consent will be taken. First, each
patient’s demographic information including age, height and weight will be gathered
as a baseline data. Pre- Intervention measurements of outcome variables including
Stability (closed kinetic chain upper extremity stability test), Coordination (plate-tapping test), Speed (plate-tapping test), Agility (agility T-test), power (vertical jump), Strength (sitting medicine ball throw test), Range of motion (goniometer)
will be taken. Intervention will be given for 6 weeks and then post-intervention data
of all the outcome variables will be taken. |