| CTRI Number |
CTRI/2021/04/032671 [Registered on: 08/04/2021] Trial Registered Prospectively |
| Last Modified On: |
18/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation between balance and lower limb strength in semi professional football players |
|
Scientific Title of Study
|
Relationship between dynamic balance and lower quarter strength in amateur football players |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Sairam |
| Designation |
Post graduate Student |
| Affiliation |
Manipal Academy of Higher Eduacation |
| Address |
Upper Basement , Department of Physiotherapy, Manipal Hospital, No 98, Rustam Bagh, Old Airport Road,
Bangalore, Karnataka
Upper Basement , Department of Physiotherapy, Manipal Hospital, No 98, Rustam Bagh, Old Airport Road,
Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
7981257696 |
| Fax |
|
| Email |
ramsai4208@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karvannan H |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore Bangalore KARNATAKA 560017 India
98, Rustam Bagh, Old Airport Road,
Bangalore
KARNATAKA
560017
India |
| Phone |
9986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Prem |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore Bangalore KARNATAKA 560017 India
98, Rustam Bagh, Old Airport Road,
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal Hospital #98, HAL,Old Airport Road, Bangalore Bangalore KARNATAKA 560017 India Bangalore KARNATAKA 560017 India |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore Bangalore KARNATAKA 560017 India Bangalore KARNATAKA 560017 India |
| 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 |
| Sairam |
Manipal Hospital |
Upper Basement , Department of Physiotherapy, Manipal Hospital, No 98, Rustam Bagh, Old Airport Road,
Bangalore, Karnataka
Bangalore
KARNATAKA |
7981257696
ramsai4208@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Foot ball players |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Male |
| Details |
Actively participating in Foot Ball atleast 5hrs/Week
Actively participating in Football since 1 year |
|
| ExclusionCriteria |
| Details |
History of previous ligament injuries around knee and ankle
History of fractures in Hip, Knee and Ankle |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knee Muscle strength using Hand Held Dynamometer |
Immediate observation only at Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Y Balance test |
Immediate observation only at baseline |
| Trunk Muscle strength using Hand Held dynamometer |
Immediate observation only at Baseline |
| Hip Muscle strength using Hand Held Dynamometer |
Immediate observation only at Baseline |
| Ankle Muscle strength using Hand Held Dynamometer |
Immediate Observation only at Baseline |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2021 |
| Date of Study Completion (India) |
15/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Literature suggest that dynamic balance and muscle strength of Trunk, Hip , Knee and Ankle are important factors in foot ball player for dynamic balance and Injury prevention |