| CTRI Number |
CTRI/2025/10/095553 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Checking How Football Players Run on Slopes Compared to Level Ground |
|
Scientific Title of Study
|
Evaluate Lower Limb Kinematics During Upslope And Downslope Running Versus Flat Running Among Football Players At Parul University |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Bharatkumar Shah |
| 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 |
6353580995 |
| Fax |
|
| Email |
dr.divyashah08@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 |
8759858568 |
| Fax |
|
| Email |
dharmang.vyas@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Divya Bharatkumar Shah |
| 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 |
6353580995 |
| Fax |
|
| Email |
dr.divyashah08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Physiotherapy PO Limda TAL. Waghodia DIST.Vadodara Gujarat India 391760 |
|
|
Primary Sponsor
|
| Name |
Divya Bharatkumar Shah |
| Address |
Parul Institute of Physiotherapy Parul University PO 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 Divya Bharatkumar Shah |
Parul Sevashram Hospital |
Room No 18.2 Orthopedic Opd Ground Floor Parul Sevashram Hospital Parul University PO Limda TAL. Waghodia DIST. VAdodara
Vadodara
GUJARAT |
06353580995
dr.divyashah08@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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Participants Aged 18-30 Years
Individuals Playing Football Since 6 months
Engaging in Running Atleast 3 Times a Week
Willingness to Participate in the study and Provide Informed Consent |
|
| ExclusionCriteria |
| Details |
Any Current Musculoskeletal Injuries Affecting the Lower Extremities
Individuals with Chronic Cardiovascular or Respiratory Conditions
Use of Medications that Affects Muscle Function or Cardiovascular Response
History of Significant Biomechanical issues (eg Flat Feet Leg Length Discrepancy) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The GaitON system captures 3D hip knee and ankle movements to analyze how running mechanics change on flat uphill and downhill surfaces |
0ne Time Assessment
Observational Study No Intervention Given |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="91"
Sample Size from India="91"
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)
|
02/11/2025 |
| 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="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
|
Running-related injuries are common, and terrain plays a key role in biomechanics and injury prevention. Comparing running on slopes versus flat ground helps reveal how the body adapts, guiding athlete training, performance enhancement, and rehabilitation strategies Recreational football players from Parul University will be screened using inclusion and exclusion criteria and will provide informed consent. Eligible participants will be randomly assigned to two groups: Group A (upslope vs. flat running) and Group B (downslope vs. flat running). All participants will undergo outcome assessment using GaitON motion analysis. |