Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000330549
Ethics application status
Approved
Date submitted
21/12/2023
Date registered
25/03/2024
Date last updated
25/03/2024
Date data sharing statement initially provided
25/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of 3D-printed silicone medial arch support in flatfoot patients: a randomized-controlled trial
Scientific title
A randomised controlled trial investigating the use of 3D-printed silicone medial arch support for pain and foot function amongst flatfoot patients
Secondary ID [1] 311235 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain associated with flatfoot 332442 0
Condition category
Condition code
Physical Medicine / Rehabilitation 329134 329134 0 0
Physiotherapy
Musculoskeletal 329665 329665 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with flatfoot are randomized to receive soft and hard 3D-printed arch supports. The soft and hard medial arch supports are made of silicone materials with hardness of 35 and 70 shore OO, respectively. The patients must wear the chosen pair of shoes with silicone arch supports for the complete 12-week duration of the study. They must record wearing hours daily and being examined by a single experienced physiatrist at 2, 6 and 12-week follow-ups.
Intervention code [1] 327691 0
Treatment: Devices
Comparator / control treatment
The comparator is customized full-length insole that is clinically used in the hospital for flatfoot treatment. The patients must wear the chosen pair of shoes with full-length insole for the complete 12-week duration of the study.They must record wearing hours daily and being examined by a single experienced physiatrist at 2, 6 and 12-week follow-ups.
Control group
Active

Outcomes
Primary outcome [1] 336967 0
pain
Timepoint [1] 336967 0
baseline and 2,6 and 12 weeks (primary timepoint) after intervention commencement.
Primary outcome [2] 336968 0
foot function
Timepoint [2] 336968 0
baseline and 2,6 and 12 weeks (primary timepoint) after intervention commencement.
Secondary outcome [1] 430276 0
foot pressure
Timepoint [1] 430276 0
baseline, immediately after commencement of intervention and 12 weeks after commencement of intervention

Eligibility
Key inclusion criteria
flexible flatfoot with pain score between 3 to 8 for a minimum of 4 weeks. Flexible flatfoot is determined by a physiatrist using Chippaux-Smirak index.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who have rigid foot deformity, a previous 1-year foot and ankle surgery, a medical history of steroid injections within the past 3 months, and other health problems associated with walking ability such as knee arthritis, diabetes, peripheral artery disease, and peripheral neuropathy are excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence using random block size of 6 created by computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/06/2022
Date of last participant enrolment
Anticipated
Actual
22/03/2023
Date of last data collection
Anticipated
Actual
21/08/2023
Sample size
Target
75
Accrual to date
Final
78
Recruitment outside Australia
Country [1] 26051 0
Thailand
State/province [1] 26051 0

Funding & Sponsors
Funding source category [1] 315491 0
Government body
Name [1] 315491 0
Health Systems Research Institute (HSRI)
Country [1] 315491 0
Thailand
Primary sponsor type
Government body
Name
National Science and Technology Development Agency (NSTDA)
Address
111 Thailand Science Park, Pathumthani
Country
Thailand
Secondary sponsor category [1] 317566 0
University
Name [1] 317566 0
Thammasat University
Address [1] 317566 0
Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Thammasat University
Country [1] 317566 0
Thailand
Secondary sponsor category [2] 317567 0
University
Name [2] 317567 0
Thammasat University Hospital
Address [2] 317567 0
Department of Physical Medicine and Rehabilitation, Thammasat University Hospital
Country [2] 317567 0
Thailand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314395 0
Ethics Committee of Thammasat University
Ethics committee address [1] 314395 0
Ethics committee country [1] 314395 0
Thailand
Date submitted for ethics approval [1] 314395 0
02/02/2022
Approval date [1] 314395 0
28/04/2022
Ethics approval number [1] 314395 0
MTU-EC-OO-4-038/65

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131430 0
Dr Siranya Paecharoen
Address 131430 0
Faculty of Medicine, Thammasat University, 99/209 Moo 18 Phahonyothin Rd, Khlong Nueng, Khlong Luang District, Pathum Thani 10120, Thailand.'
Country 131430 0
Thailand
Phone 131430 0
+6629269225
Fax 131430 0
Email 131430 0
[email protected]
Contact person for public queries
Name 131431 0
Siranya Paecharoen
Address 131431 0
Faculty of Medicine, Thammasat University, 99/209 Moo 18 Phahonyothin Rd, Khlong Nueng, Khlong Luang District, Pathum Thani 10120, Thailand
Country 131431 0
Thailand
Phone 131431 0
+6629269225
Fax 131431 0
Email 131431 0
[email protected]
Contact person for scientific queries
Name 131432 0
Siranya Paecharoen
Address 131432 0
Faculty of Medicine, Thammasat University, 99/209 Moo 18 Phahonyothin Rd, Khlong Nueng, Khlong Luang District, Pathum Thani 10120, Thailand
Country 131432 0
Thailand
Phone 131432 0
+6629269225
Fax 131432 0
Email 131432 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.