NCT03249805: mFAB

MiracleFeet Foot Abduction Brace Sensor Trial

Status unknown NA Last updated 17 August 2018

What this trial tests

NA trial testing Steenbeek Foot Abduction Brace (SFAB) in Clubfoot in 80 participants. Status unknown.

Timeline

7 June 2017

Primary endpoint
31 December 2018

31 December 2018

Quick facts

Lead sponsor	MiracleFeet
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	80
Start date	7 June 2017
Primary completion	31 December 2018
Estimated completion	31 December 2018
Sites	1 location across India

Drugs / interventions tested

• Steenbeek Foot Abduction Brace (SFAB)
• MiracleFeet Foot Abduction Brace (mFAB)

Conditions studied

• Clubfoot — all drugs for Clubfoot →
• Telemedicine — all drugs for Telemedicine →
• Patient Compliance — all drugs for Patient Compliance →

Sponsor

MiracleFeet

Who can join

Adults 3 Months to 1, any sex, with Clubfoot or Telemedicine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to determine the effect of a new design of FAB type on compliance and treatment outcomes of idiopathic clubfeet treated by the Ponseti method. Very little literature exists on the effect of brace type or the difference between reported and actual at-home compliance, which is integral to the success of treatment with the Ponseti method. Eighty children less than 1 year of age will be enrolled in the study into two arms, using block randomization. These two groups will use two different designs of foot abduction brace (FAB). Outcomes will be measured by number of recurrences per group (using recasting and/or surgical procedures and Pirani score as indicators), time of recurrences (in months), compliance with brace wear using sensors and comparing the data with brace wear reported by parents, and parent satisfaction with FAB (measured on a modified Orthotics and Prosthetics User Sur vey). Enrollment will be on a rolling basis; subjects will be enrolled at their last cast application and followed for approximately 6 months. Recurrences, time of recurrence, parent satisfaction, and reported vs. actual compliance will be analyzed.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interventions for congenital talipes equinovarus (clubfoot).
   Bina S, Pacey V, Barnes EH, Burns J, et al · · 2020 · cited 18× · PMID 32412098 · DOI 10.1002/14651858.cd008602.pub4