| CTRI Number |
CTRI/2024/10/075790 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving foot health: effect of short foot exercises in improving foot posture and reducing pain in young adults with flexible flat foot |
|
Scientific Title of Study
|
Effect of short foot exercise on foot posture, pain and disability in flexible flat foot among young adults- Pre-post 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 |
Dheeraj P S |
| Designation |
Post graduate resident |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
MPT 1st year classroom, MPT Divsion, Yenepoya Physiotherapy
College. Naringana, Deralakatte Mangalore
Dakshina Kannada
KARNATAKA
575718
India |
| Phone |
8884648742 |
| Fax |
|
| Email |
dheerajps247@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nigath Fathima |
| Designation |
Associate professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Staff Division, Yenepoya Physiotherapy College.
Naringana, Deralakatte Mangalore
Dakshina Kannada
KARNATAKA
575718
India |
| Phone |
7406225106 |
| Fax |
|
| Email |
fathimanigat@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dheeraj P S |
| Designation |
Post graduate resident |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
MPT 1st year classroom, MPT Divsion, Yenepoya Physiotherapy
College. Naringana, Deralakatte Mangalore
Dakshina Kannada
KARNATAKA
575718
India |
| Phone |
8884648742 |
| Fax |
|
| Email |
dheerajps247@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dheeraj P S |
| Address |
Yenepoya Physiotherapy College. Naringana, Deralakatte
Mangalore - 575018. Karnataka Dakshina Kannada KARNATAKA
575018 India
|
| Type of Sponsor |
Other [self] |
|
|
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 Dheeraj P S |
Yenepoya medical college hospital |
Physiotherapy OPD, Department of Physiotherapy, Yenepoya deemed to be university, Derlakatte, Manglore
Dakshina Kannada
KARNATAKA |
08884648742
dheerajps247@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Flexible flat foot |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
short foot exercise |
3 sets,10 repetition, 5 seconds hold for each repetition
Thrice a week for 6-weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Navicular drop height more than 10 mm
Symptomatic flexible flat foot |
|
| ExclusionCriteria |
| Details |
Congenital deformity of lower limb
Recent injuries to lower limb
Current inflammatory arthritis
Foot or ankle surgery history
Any neurologic condition
Limb length discrepancy more than 2cm.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Navicular drop test
Foot posture index-6
|
Baseline and Post intervention (After 6 weeks)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Foot function index |
Baseline and Post intervention (After 6 weeks)
|
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
04/11/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 aim of the study is "To find the Effect of short foot exercise on foot posture, pain and disability in
flexible flat foot among young adults". Total sample size of the study is 35, The subjects who fulfil the inclusion and
exclusion criteria, the baseline assessment will be taken only after explaining the study procedure and signing informed consent.
Foot posture, pain, and disability will be evaluated, foot posture will be
evaluated using the navicular drop test and foot posture index-6, pain and
disability will be evaluated using the foot function index and the results will be
recorded, this data will be taken as baseline data. Then all the participants will
perform short foot exercises of 3 sets,10 repetition, 5 seconds
hold for each repetition, thrice a week for 6-weeks
. Navicular drop test, foot posture
index-6, and foot function index will be evaluated again after 6-weeks of
intervention |