| CTRI Number |
CTRI/2024/04/065682 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
13/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
CORRELATIONAL STUDY |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A correlation study on amateur(not professional) football players that how their pelvis position can affect their power generation and their ability to change direction quickly |
|
Scientific Title of Study
|
Impact of pelvic alignment on explosive strength and change of direction ability in amateur football players: A correlational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavesh Sahu |
| Designation |
Research Scholar, MPT |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Room No. QS 10 , Q block , Department of physiotherapy, Manav Rachna International Institute of Research and Studies, Sector-43, Delhi-Surajkund Road Faridabad, Haryana, 121004
Faridabad
HARYANA
121004
India |
| Phone |
7869725020 |
| Fax |
|
| Email |
bhaveshdpu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kshitija Bansal |
| Designation |
Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
QS 6/04, Q block, department of physiotherapy,Manav Rachna International Institute of Research and Studies, Sector-43, Delhi-Surajkund Road Faridabad, Haryana, 121004
Faridabad
HARYANA
121004
India |
| Phone |
9810314488 |
| Fax |
|
| Email |
kshitijabansal.sahs@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kshitija Bansal |
| Designation |
Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
QS 6/04, Q block, Department of physiotherapy,Manav Rachna International Institute of Research and Studies, Sector-43, Delhi-Surajkund Road Faridabad, Haryana, 121004
Faridabad
HARYANA
121004
India |
| Phone |
9810314488 |
| Fax |
|
| Email |
kshitijabansal.sahs@mriu.edu.in |
|
|
Source of Monetary or Material Support
|
| MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES, FARIDABAD , HARYANA, 121004 |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NONE |
| Type of Sponsor |
Other [NONE] |
|
|
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 |
| Bhavesh Sahu |
MANAV RACHNA SPORTS ACADEMY |
Gate No-3, Football ground, Sector 14, Faridabad.
Faridabad
HARYANA |
7869725020
bhaveshdpu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Manav Rachna International Institute of Research and Studies, Faridabad, Haryana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NO HEALTH CONDITIONS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
1 Amateur football players performing at club and University level.
2 Amateur football players practicing for more than 6 months.
|
|
| ExclusionCriteria |
| Details |
1 Players with recent musculoskeletal injuries last 6 months.
2 Players with any diagnosed orthopedic, neurological, or cardiovascular diseases.
3 Any Surgery on lower limb or spine in last 6 months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
. Vertical jump height
. Agility T-test time
|
8 WEEKS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NONE |
NONE |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
25/04/2024 |
| 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="3"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 15-08-2024 and end date provided 27-11-2024?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
To study the impact of pelvic alignment on explosive strength, and changes of direction ability in amateur football players. Participants will be selected on the basis of inclusion criteria and will be excluded depending on exclusion criteria. Participants will be
informed prior about the study and to read and signed an informed consent form. Participants will be demonstrated prior how to perform vertical jump and agility t test. Participants are allowed to take part in voluntarily and drop off at any point of study. Final data collected will be used in synthesis of statical analysis and result |