| CTRI Number |
CTRI/2025/08/093717 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to determine if compliance with brace use is better with Iowa brace as compared with any other conventional brace for children with clubfoot |
|
Scientific Title of Study
|
A quasi-experimental study to determine the difference in compliance rates between the use of any conventional brace and the Iowa brace for idiopathic clubfoot |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gauri A Oka |
| Designation |
Research Consultant |
| Affiliation |
Bharati Vidyapeeth Deemed to be Univerisity Medical College and Hositpal, Pune |
| Address |
Central Research and Publication Unit, Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9823828445 |
| Fax |
|
| Email |
gauri.oka@bharatividyapeeth.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gauri A Oka |
| Designation |
Research Consultant |
| Affiliation |
Bharati Vidyapeeth Deemed to be Univerisity Medical College and Hositpal, Pune |
| Address |
Central Research and Publication Unit, Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9823828445 |
| Fax |
|
| Email |
gauri.oka@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gauri A Oka |
| Designation |
Research Consultant |
| Affiliation |
Bharati Vidyapeeth Deemed to be Univerisity Medical College and Hositpal, Pune |
| Address |
Central Research and Publication Unit, Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9823828445 |
| Fax |
|
| Email |
gauri.oka@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Clubfoot Solutions,
Iowa, USA |
|
|
Primary Sponsor
|
| Name |
Clubfoot Solutions |
| Address |
Clubfoot Solutions,
Iowa, USA |
| Type of Sponsor |
Other [Non-profit organization] |
|
|
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 Gauri A Oka |
Bharati Vidyapeeth Deemed to be Univerisity Medical College and Hositpal |
9th Floor
Super Specialty Building
Central Research And Publication Unit
Dhankawadi
Pune Satara Road
Pune 411043
Pune
MAHARASHTRA |
9823828445
gauri.oka@bharatividyapeeth.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University) Medical College Insitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q660||Congenital talipes equinovarus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clubfoot brace (Iowa brace) |
A brace for clubfoot correction |
| Comparator Agent |
Conventionally used brace |
Any conventionally used brace for idiopathic clubfoot |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
A child (any gender) who is less than 5 years old and who is diagnosed with unilateral or bilateral idiopathic clubfoot and has been using any brace for at least 6 months, with at least 9 months of brace use remaining. |
|
| ExclusionCriteria |
| Details |
Refusal of parental consent
Current or prior use of Iowa brace |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the difference in compliance rates among patients with idiopathic clubfoot using any conventional brace and the Iowa brace |
3, 6, 9 month follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the brace-related factors associated with compliance with its use among patients diagnosed with idiopathic clubfoot |
3, 6, 9 month follow-up |
|
|
Target Sample Size
|
Total Sample Size="238"
Sample Size from India="238"
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)
|
08/09/2025 |
| 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="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
|
The study
will begin after Ethics Committee approval. The parents of eligible candidates
will be provided a verbal, detailed explanation about the study by a study team
member, and an information sheet explaining the same will be handed out to
them. After allowing sufficient time for consideration, and if informed consent
is provided by the parent for their child’s participation in the study, the
child will be enrolled. A data collector will procure information using the
data collection form in the local language or English as may be required.
Data will
be collected at baseline (to document details of use of the current conventional
brace), after which the parents will be provided the Iowa brace free of charge.
The parents will be instructed to use the Iowa brace according to the
specifications. Data collection will be repeated using the same data collection
form at 3, 6, and 9 months of using the Iowa brace.
The data
will be entered in hard copies and transferred into an Excel sheet for
analysis.
The
parents will be assured that they can drop out of the study at any point, and
may decide to stop using the Iowa brace and opt for using any brace of their
choice at any point in
the study without any effect whatsoever on the quality of care provided to
their child.
|