CTRI

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CTRI Number

CTRI/2026/01/101101 [Registered on: 14/01/2026] Trial Registered Prospectively

Last Modified On:

14/01/2026

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

To Develop a prediction equation to identify pronation distortion syndrome condition in athletic population: a cross sectional study

Scientific Title of Study

Development and Validation of a Multivariate Diagnostic Prediction Model for Pronation Distortion Syndrome in Competitive Athletes

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Uma Raghav
Designation	Clinical Demonstrator
Affiliation	Manav Rachna International Institute of Research and Studies
Address	Department of Physiotherapy, SAHS, Manav Rachna International Institute of Research and Studies, Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad Department of Physiotherapy, SAHS, Manav Rachna International Institute of Research and Studies, Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad Faridabad HARYANA 121004 India
Phone	9711513117
Fax
Email	umaraghav.sahs@mriu.edu.in

Details of Contact Person
Scientific Query

Name	Dr Jasmine Kaur Chawla
Designation	Associate Professor
Affiliation	Manav Rachna International Institute of Research and Studies
Address	Department of Physiotherapy, SAHS, Manav Rachna International Institute of Research and Studies, Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad Department of Physiotherapy, SAHS, Manav Rachna International Institute of Research and Studies, Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad Faridabad HARYANA 121004 India
Phone	9888263685
Fax
Email	jasminekaur.sahs@mriu.edu.in

Details of Contact Person
Public Query

Name	Dr Jasmine Kaur Chawla
Designation	Associate Professor
Affiliation	Manav Rachna International Institute of Research and Studies
Address	Department of Physiotherapy, SAHS, Manav Rachna International Institute of Research and Studies, Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad Department of Physiotherapy, SAHS, Manav Rachna International Institute of Research and Studies, Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad Faridabad HARYANA 121004 India
Phone	9888263685
Fax
Email	jasminekaur.sahs@mriu.edu.in

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Manav Rachna International institute of research and studies
Address	Manav Rachna Campus Rd Gadakhor Basti Village Sector 43 Faridabad Haryana 121004
Type of Sponsor	Other [University]

Details of Secondary Sponsor

Name	Address
nil	nil

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Uma Raghav	Electrotherapy Lab	Department of Physiotherapy, SAHS, Manav Rachna International Institute of Research and Studies, Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad Department of Physiotherapy, SAHS, Manav Rachna International Institute of Research and Studies, Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad Faridabad HARYANA	09711513117 umaraghav.sahs@mriu.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Research Ethics Committe, Manav Rachna International Institute of Research and Studies	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Pronation Distortion Syndrome

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil
Intervention	Nil	Nil
Intervention	Nil	Nil
Intervention	Nil	Nil
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	30.00 Year(s)
Gender	Both
Details	History of orthopedic surgery or major trauma to the lower extremities or spine. Current acute or chronic foot, knee, hip, or lower back pain. Neurological disorders, balance disorders, or vestibular dysfunction. Known systemic or chronic diseases (e.g., uncontrolled diabetes, rheumatoid arthritis) that may affect postural control or joint alignment. Inability to complete all assessment procedures due to pain, discomfort, or lack of compliance. Use of orthotic devices that alter the natural foot posture during assessment.

ExclusionCriteria

Details

History of orthopedic surgery or major trauma to the lower extremities or spine.
Current acute or chronic foot, knee, hip, or lower back pain.
Neurological disorders, balance disorders, or vestibular dysfunction.
Known systemic or chronic diseases (e.g., uncontrolled diabetes, rheumatoid arthritis) that may affect postural control or joint alignment.
Inability to complete all assessment procedures due to pain, discomfort, or lack of compliance.
Use of orthotic devices that alter the natural foot posture during assessment.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
assessment of foot posture, muscle strength, plantar pressure distribution and balance	6weeks

Secondary Outcome

Outcome	TimePoints
assessment of biomechanical, psychological and neuromuscular variables for any foot deformity	6 weeks

Target Sample Size

Total Sample Size="472"
Sample Size from India="472"
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)

16/02/2026

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="0"
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

Participants will be included based on the inclusion and exclusion criteria. Subject will be informed prior about the study and to read and sign an informed consent form. Before participation, all eligible participants will be informed in detail about the purpose, procedures, and potential implications of the study. Written informed consent will be obtained from each participant.

Demographic data will be collected from all participants. The data collection form will be used to record findings of biomechanical, neuromuscular and balance, and psychological parameters related to Pronation Distortion Syndrome. Statistical analysis will be done. A prediction equation will be developed.