CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2023/10/058507 [Registered on: 11/10/2023] Trial Registered Prospectively

Last Modified On:

06/10/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Other

Public Title of Study

To see the effect of inner muscles of the foot strength training on foot function, medial longitudinal arch and dynamic parameters among individuals with flat foot: an experimental study

Scientific Title of Study

The effect of intrinsic foot flexor strength training on foot function, medial longitudinal arch and dynamic parameters among individuals with flat foot: An Experimental study

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Manan Patel
Designation	M.P.T. Scholar
Affiliation	Parul University
Address	Parul Institute of Physiotherapy Limda, Waghodia Vadodara GUJARAT INDIA Vadodara GUJARAT 390019 India
Phone	8200213770
Fax
Email	mananpatel110298@gmail.com

Details of Contact Person
Scientific Query

Name	Dr. Prachi Shah
Designation	Assistant Proffesor
Affiliation	Parul University
Address	Parul Institute of Physiotherapy Limda, Waghodia Vadodara GUJARAT INDIA Vadodara GUJARAT 390019 India
Phone	7574861708
Fax
Email	prachi.choksi28194@paruluniversity.ac.in

Details of Contact Person
Public Query

Name	Manan Patel
Designation	M.P.T. Scholar
Affiliation	Parul University
Address	Parul Institute of Physiotherapy Limda, Waghodia Vadodara GUJARAT INDIA Vadodara GUJARAT 390019 India
Phone	8200213770
Fax
Email	mananpatel110298@gmail.com

Source of Monetary or Material Support

Room No. 230, Second Floor, Parul Sevashram Hospital, Parul University, Limda, Waghodia, Vadodara

Primary Sponsor

Name	Manan Patel
Address	Parul Institute of Physiotherapy, Parul University, Vadodara, Gujarat
Type of Sponsor	Other [self]

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
Manan Patel	Parul Sevashram Hospital	Room no.201 2nd floor,Physiotherapy Department Vadodara GUJARAT	8200213771 mananpatel110298@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Parul university Institutional ethical committee for human research	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	pes planus

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Foot and Ankle Disability Index, Clark Angel and Dynamic Parameters.	Outcome measures will be assessed before and after 6 weeks of intervention
Intervention	Strengthening Exercises	Duration - 6 weeks repetition - 10 times hold time - 5 seconds rest time - 5 seconds

Inclusion Criteria

Age From	18.00 Year(s)
Age To	25.00 Year(s)
Gender	Both
Details	Subjects with bilateral flat foot. Subjects who are willing to participate in the study FADI score less than or equal to 25. Clarke angle less than or equal 34.9 or less.

ExclusionCriteria

Details

Congenital flat foot.
Subjects with musculoskeletal injuries of either limb in the last 6 months.
History of foot and ankle surgery.
Individuals with neurological and neuromuscular conditions.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Foot and Ankle Disability Index	6 weeks

Secondary Outcome

Outcome	TimePoints
Clarke angle Dynamic Parameters using Vertical jump test & Single legged long jump	6 weeks

Target Sample Size

Total Sample Size="120"
Sample Size from India="120"
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)

20/10/2023

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="9"
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

The prevalence rate of flat foot is 10.75% among 18-25 year old Indian population .Flat foot can lead to multiple problems like plantar fasciitis, altered mechanism of foot which can in turn lead to knee, hip and back problems. Hence it becomes important to preserve the normal structure of the foot that includes medial & longitudinal arches and strong and active intrinsic muscles of the foot. To preserve the foot structure, the intrinsic flexor muscles of the foot help to stabilize the foot and support the arches. One of the reasons for flat foot is the weakening or inactivity of the intrinsic muscles of the foot.

There have been several studies done to check the effect of medial arch support and exercises in the form of toe curls to assess improvement in function and arches of foot among individuals with flat foot. But there have been very few studies that prove the effect of strengthening and activation of intrinsic foot muscles on foot function, medial longitudinal arch and dynamic parameter like vertical jump test and single legged long jump.

Thus this study will analyze the effect of intrinsic foot flexors strengthening on foot function, medial longitudinal arch and dynamic parameters among individuals with flat foot.