| CTRI Number |
CTRI/2024/09/073687 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Correlational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation of Foot Posture with Balance and Quality of Movement in Football Players |
|
Scientific Title of Study
|
Correlation of Foot Posture with Balance and Quality of Movement in Football Players |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Leela Choudhary |
| Designation |
Post Graduate |
| Affiliation |
|
| Address |
AIMS Campus Ahmedabad Institute of Medical Sciences Nr SP Ring Road Ognaj Circle Nr Lions Karnavati Eye Hospital Gota Kalol Highway Lapkaman Ahmedabad
Ahmadabad
GUJARAT
380060
India |
| Phone |
9727278065 |
| Fax |
|
| Email |
cleelachoudhari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopi Contractor |
| Designation |
Lecturer and PG Guide |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
AIMS Campus Ahmedabad Institute of Medical Sciences Nr SP Ring Road Oganj Circle Nr Lions Karnavati Eye Hospital Gota Kalol Highway Lapkaman, Ahmedabad
Ahmadabad
GUJARAT
380060
India |
| Phone |
9924356309 |
| Fax |
|
| Email |
gtgopi2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopi Contractor |
| Designation |
Lecturer and PG Guide |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
AIMS Campus Ahmedabad Institute of Medical Sciences Nr SP Ring Road Oganj Circle Nr Lions Karnavati Eye Hospital Gota Kalol Highway Lapkaman, Ahmedabad
Ahmadabad
GUJARAT
380060
India |
| Phone |
9924356309 |
| Fax |
|
| Email |
gtgopi2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ahmedabad Institute Of Medical Sciences Nr.S.P.Ring Road Ognaj Circal Gota-Kalol Highway
Lapkaman Ahmedabad Gujarat India 380060 |
|
|
Primary Sponsor
|
| Name |
Leela Choudhary |
| Address |
AIMS Campus Ahmedabad Institute of Medical Sciences Nr SP Ring Road Oganj Circle Nr Lions Karnavati Eye Hospital Gota Kalol Highway Lapkaman Ahmedabad |
| Type of Sponsor |
Private medical college |
|
|
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 Gopi Contractor |
Ahmedabad Institute of Medical Sciences |
101 Exercise Therapy Lab AIMS OPD Ahmedabad Institute Of Medical Sciences near SP Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad
Ahmadabad
GUJARAT |
9924356309
gtgopi2007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research And Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Football Players |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
Gender- Only male players
Playing football since 3 years
Playing football 4 session/ week
Playing football 2 hour/ session
Recreational players
|
|
| ExclusionCriteria |
| Details |
• Severe musculoskeletal, cardiopulmonary and neurological condition
• Lower extremity surgery in past 3 months
• Indulge in other sport activities
• Goalkeeper
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Foot Posture Index (FPI-6)
|
Immediate after the observation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Functional Movement Screen (FMS)
• Y- Balance Test (YBT)
|
Immediate after the observation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
NEED OF THE
STUDY
In football, the
foot is a unique anatomical, neurophysiologic, and functional structure that
makes it possible to do difficult actions and maneuvers like standing, walking,
and sprinting.[2] While playing football, foot injuries are common. It has been theorized
that different foot postures affect how the lower limbs operate and cause
injury.[1] Therefore, abnormal foot posture may affect balance and
movement quality, which may directly affect over all performance of football
players. From here, need of the study arises to check correlation of foot
posture with dynamic balance and quality of movement, to improve performance of
the football player.
AIM
To check the correlation
of different foot posture with dynamic balance and quality of movement in
football players.
OBJECTIVES
· To assess foot posture by using foot posture index in
football players.
· To assess quality of movement by using functional
movement screen in football players.
· To assess dynamic balance by using y balance test
score in football players.
·
To
check correlation of balance and foot posture in football players.
·
To
check correlation of functional movement and foot posture in football players.
PROCEDURE
After taking ethical approval from Institutional
Ethical Committee, Football Players from various sports clubs and stadiums will
be included in the study. After screening from inclusion and exclusion
criteria. Players who fulfill the criteria of the study and willing to
participant will be included. Written consent will be taken from the players,
who are participating.
The foot posture
index (FPI-6) will be used to scan and score the individuals’ feet first. This
foot posture index is a verified measurement technique that has been used in
many studies to characterize foot morphology and permits classification between
three possible foot positions: supinated, pronated, or neutral. It assesses the
foot of the subject using six parameters and provides a score that is gradually
added up. The parameters are as follow- palpation of the talar head (A);
supralateral and infra-lateral malleolus curvature (B); position of the frontal
plane of the calcaneus (C); prominence in the neutral joint of the talar region
(D); congruence of the medial longitudinal arch (E); and abduction/adduction of
the forefoot over the hindfoot (F). Each criterion is evaluated from 2 to +2, with a
range of −12 to +12. The total score can range from the maximum that would indicate a pronated foot
position (+6 to +12), to an intermediate score (0 to +5) that corresponds to a
neutral foot position, and the lowest possible score, which would be 12 to 1
and would be considered a supinated foot position.[1]
To assess movement quality, Functional Movement Screen
(FMS) tool will be used. For objective detection of body mobility, stability
and movement control in athletes, and evaluates the quality of fundamental
movement patterns to identify limitations or asymmetries in individuals. The
seven tests are- deep squat (A), inline lunge (B), shoulder mobility assessment
(C), active straight-leg raise (D), trunk stability push-up (E), hurdle step
(F), rotary stability (G)[1]. Each test is evaluated on a scale of 0–3, and
each individual performed each task three times, recording the lowest score achieved.
score of 3 means that the participant has a correct movement pattern, a score of
2 means that the movement occurs with compensation but not in the correct way,
and a score of 1 means that he could not perform the task in a coordinated or
correct way, and 0 means that the subject has pain at any time during the
movement. The total result of the sum of all points ranges from 0 to 21 points
and allows the classification of the movement quality as perfect = 21, optimal
14–20, and poor <14. [1]A screening tool
called the YBT is used to assess dynamic balance in the anterior (A), posteromedial
(PM), and posterolateral (PL) directions. Prior to the test, each participant’s
anatomical leg length will be measured in the supine position and recorded as
the distance between the distal end of the ipsilateral medial malleolus and the
anterior superior iliac spine. Participants will complete three practice trials
for each direction on each leg prior to the data-collection trials, after which
they will move to a different station and have about five minutes to recover
before being tested for three maximum reaches in the A, PM, and PL reach
directions on the right and left legs. Reach distances are given as a
percentage of leg length (reach distance/limb length) X 100 after being
normalized to anatomical leg length. The formula for calculating the composite
normalized reach distance for each leg is (ANT + PM + PL) / (3 X limb length) X
100. The difference in reach distance from right to left will be measured in
centimeters (reach distance = [maximum right reach distance - maximum left
reach difference]), and the total amount of reach asymmetry will be determined
by adding the three reach direction differences.[3]
|