| CTRI Number |
CTRI/2025/09/094364 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
06/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
The Role of Exercise and Fatigue on Foot Movement and Pressure in Football Player |
|
Scientific Title of Study
|
Effectiveness of Exercise on Stance Time, Maximum Pressure Time and Foot Progression Angle Before and After Fatigue among 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 |
Avani Jog |
| Designation |
Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Room no 18.2 Orthopedic OPD ground floor Parul Sevashram Hospital Parul University PO Limda Tal. Waghodia Dist. Vadodara
Vadodara GUJARAT 391760 India |
| Phone |
8359825789 |
| Fax |
|
| Email |
avanijogujjain29@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dharmang Vyas |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Room no 18.2 Orthopedic OPD ground floor Parul Sevashram Hospital Parul University PO Limda Tal. Waghodia Dist. Vadodara
Vadodara GUJARAT 391760 India |
| Phone |
8758958568 |
| Fax |
|
| Email |
dharmang.vyas@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Avani Jog |
| Designation |
Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Room no 18.2 Orthopedic OPD ground floor Parul Sevashram Hospital Parul University PO Limda Tal. Waghodia Dist. Vadodara
Vadodara GUJARAT 391760 India |
| Phone |
8359825789 |
| Fax |
|
| Email |
avanijogujjain29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Physiotherapy P.O Limda Tal. Waghodia Dist. Vadodara Gujarat India 391760 |
|
|
Primary Sponsor
|
| Name |
Avani Jog |
| Address |
Parul Institute of Physiotherapy Parul University P.O Limda Tal Waghodia Dist Vadodara Gujarat India 391760 |
| Type of Sponsor |
Other [Physiotherapy] |
|
|
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 Avani Jog |
Parul Sevashram Hospital |
Room no 18 Orthopedic Physiotherapy OPD Parul University P.O Limda Tal Waghodia Dist Vadodara Vadodara GUJARAT |
8359825789
avanijogujjain29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Football Players |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lower Limb and Foot exercises |
Towel curls Doming Toe spread out Toe grasp gait Side bridges Unilateral calf raise Nordic curls Half squats |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Participants aged 18 to 30 years to ensure a focus on young adult athletes.
Currently active football players with at least one year of competitive experience to ensure familiarity with the sports demands.
Participants should be free from any acute pain during physical activity.
Regularly engage in at least 3 hours of football training per week to ensure a baseline level of fitness.
Willingness to provide informed consent and comply with study protocols.
|
|
| ExclusionCriteria |
| Details |
1.History of lower limb injuries (e.g., ankle sprains, ligament injuries) in the past six months that could affect foot biomechanics.
2.Any chronic conditions such as diabetes, rheumatoid arthritis, or neurological disorders that may influence foot pressure distribution or overall physical performance.
3.Presence of foot deformities (e.g., high arches, bunions) or conditions like plantar fasciitis or metatarsalgia that could affect pressure readings.
4.Use of medications that may alter muscle function or pain perception, such as analgesics or muscle relaxants, at the time of the study.
5.Female participants who are pregnant or postpartum within the last year, as this may affect physical performance and foot biomechanics.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stance Time
Maximum Pressure Time
Foot Progression Angle
Fatigue Severity Scale |
Pre- Baseline
Post- 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
21/09/2026 |
| 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="6" 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 - NO
|
|
Brief Summary
|
The study explores how running-induced fatigue affects foot pressure distribution in football players, potentially increasing the risk of foot and lower limb injuries by altering stance time, pressure time, and foot progression. It also highlights the role of strength training, conditioning, and exercises targeting running mechanics in improving resistance to fatigue and maintaining efficient foot mechanics during later stages of play. The study will recruit participants from Parul University based on inclusion criteria and informed consent. They will be randomly divided into two groups: Group A will receive a 4-week structured physiotherapy protocol, while Group B will continue their routine exercises. Both groups will undergo a controlled running protocol to induce fatigue, with foot pressure parameters measured before and after the intervention. The results of both groups will then be compared. |