| CTRI Number |
CTRI/2026/02/104365 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Immediate Effects of Heel and Big Toe Alignment Correction in Children with Flat Feet And Neurodevelopmental delay |
|
Scientific Title of Study
|
Immediate effect of calcaneal and/or hallux correction on pronated foot in children with Neurodevelopmental delay |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
V R Madhushree |
| Designation |
Physiotherapy Postgraduate |
| Affiliation |
SDM College of physiotherapy |
| Address |
SDM College of Medical Sciences and Hospitals SDM University Paediatric Physiotherapy Department,1st floor, old building OPD no 13 SDM College Of Physiotherapy SDM University Sattur, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
8970845474 |
| Fax |
|
| Email |
sreemadhu2307@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti S Jeevannavar |
| Designation |
Proffesor, PG guide |
| Affiliation |
SDM College of physiotherapy |
| Address |
SDM College of Medical Sciences and Hospitals SDM University Paediatric Physiotherapy Department,1st floor, old building OPD no 13 SDM College Of Physiotherapy SDM University Sattur, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9972189767 |
| Fax |
|
| Email |
Drjyotisj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
V R Madhushree |
| Designation |
Physiotherapy Postgraduate |
| Affiliation |
SDM College of physiotherapy |
| Address |
SDM College of Medical Sciences and Hospitals SDM University Paediatric Physiotherapy Department,1st floor, old building OPD no 13 SDM College Of Physiotherapy SDM University Sattur, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
8970845474 |
| Fax |
|
| Email |
sreemadhu2307@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
V R Madhushree |
| Address |
SDM College of Physiotherapy Sattur Dharwad Karnataka 580009 |
| 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 |
| V R Madhushree |
SDM College of Medical Sciences and Hospital Sattur Dharwad |
SDM College of Medical Sciences and Hospital Dharwad Paediatric Physiotherapy OPD no 13 Old Building Sattur Dharwad Karnataka
Dharwad
KARNATAKA |
8970845474
sreemadhu2307@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SDM College of Medical Sciences & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F82||Specific developmental disorder ofmotor function, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kinesio tapping for flatfoot |
Foot prints will be taken using non toxic colour first without taping and then with taping for heel or calcaneal and or big toe hallux correction Foot prints will be assessed using the Chippaux Smirak index |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Children diagnosed with Neurodevelopmental-delay by a medical practitioner.
2.Children with an ability to stand independently or minimal hand support. |
|
| ExclusionCriteria |
| Details |
1. Children with history of trauma / surgery / botox therapy to the lower limb in the last one year
2. Children with inability to stand
3. Child with allergy to tape / colour
4. Child with fixed lower limb deformity, CTEV and other congenital lower limb deformities(Arthrogryposis multiplex congenital , Amelia ,Hemimelia )
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Chippaux smirak index |
Baseline
post intervention |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
03/03/2026 |
| 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="1"
Months="0"
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
|
Children with neurodevelopmental delay who can stand with or without walking aid will be enrolled. After obtaining parental consent, their foot prints will be taken using non-toxic colour—first without taping and then with taping for heel (calcaneal) and/or big toe (hallux) correction. Foot prints will be assessed using the Chippaux Smirak index, and the findings will be analysed statistically. |