| CTRI Number |
CTRI/2025/05/087819 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Correlation study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation of Toe Flexor Strength and Mobility in Adulthood with Flat Feet |
|
Scientific Title of Study
|
Correlation of Toe Flexor Strength and Mobility in Middle Adulthood with Flat Feet |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shah Priyal Samir |
| Designation |
Post Graduate |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
Room no 1 Division Exercise Therapy Department Physiotherapy
Ahmedabad Institute of Medical Sciences Nr.S.P.Ring Road Ognaj Circle Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India
Ahmadabad
GUJARAT
380060
India |
| Phone |
9561199252 |
| Fax |
|
| Email |
priyalshahs243@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alpa Purohit |
| Designation |
Vice Principle,PhD, PG Guide |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
Room no 1 Division Exercise Therapy Department Physiotherapy
Ahmedabad Institute of Medical Sciences Nr.S.P.Ring Road Ognaj Circle Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India
Ahmadabad
GUJARAT
380060
India |
| Phone |
9313966648 |
| Fax |
|
| Email |
dralpaphysio@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alpa Purohit |
| Designation |
Vice Principle,PhD, PG Guide |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
Room no 1 Division Exercise Therapy Department Physiotherapy
Ahmedabad Institute of Medical Sciences Nr.S.P.Ring Road Ognaj Circle Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India
Ahmadabad
GUJARAT
380060
India |
| Phone |
9313966648 |
| Fax |
|
| Email |
dralpaphysio@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Ahmedabad Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Ahmedabad Institute of Medical Sciences |
| Address |
Room no 1 Division Exercise Therapy Department Physiotherapy
Ahmedabad Institute of Medical Sciences Nr.S.P.Ring Road Ognaj Circle Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India 380060
|
| 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 Alpa Purohit |
Ahmedabad Institute of Medical Sciences |
Room no 1 Division Exercise Therapy Department Physiotherapy
Ahmedabad Institute of Medical Sciences Nr.S.P.Ring Road Ognaj Circle Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India
Ahmadabad
GUJARAT |
09313966648
dralpaphysio@yahoo.co.in |
|
|
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 |
Flat Feet |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
34.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate in the study
Individuals with flat feet
Navicular drop test score greater than 9mm
Functionally independent in activities of daily living |
|
| ExclusionCriteria |
| Details |
Severe musculoskeletal disorders
Severe neurological disorders
Cardiopulmonary disorders
Using any walking aids
Abnormal gait pattern |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Toe Grip Dynamometer |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timed up and go Test |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="121"
Sample Size from India="121"
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)
|
07/06/2025 |
| 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
|
AIM OF STUDY
ยง To correlate Toe Flexor Strength and Mobility in Middle Adulthood with Flat Feet. OBJECTIVES OF STUDY
To evaluate Flat Feet in Middle Adulthood using Navicular Drop Test To evaluate Mobility in Middle Adulthood with flat feet using Timed up and go test. To evaluate Toe Flexor Strength of foot in Middle Adulthood with flat feet using Toe Grip Dynamometer. To correlate Toe Flexor Strength and Mobility in Middle Adulthood with Flat Feet. |