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Search / Trial NCT03249805

MiracleFeet Foot Abduction Brace Sensor Trial

Launched by MIRACLEFEET · Aug 10, 2017

Trial Information

Current as of May 30, 2025

Unknown status

Keywords

Lmic Medical Device Efficacy

ClinConnect Summary

Clubfoot is the most common birth defect affecting 1 in every 750 live births, that is about 200,000 babies each year globally (80% mainly in developing countries). An estimated average 1 million children are currently living with untreated clubfoot. In India every 10 minutes a child is born with clubfoot i.e. over 50,000 children are born with this deformity every year (1 per 500 birth). The Ponseti Method is now recognized as the accepted standard for the medical treatment of clubfoot. The Ponseti Method is ideally suited for the developing world in that it is inexpensive, non-surgical an...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Unilateral or bilateral cases of idiopathic clubfoot in children who have not yet started walking at first presentation, receiving a brace for the first time after successful correction with the Ponseti method of treatment, at the Bai Jerbai Wadia Hospital for Children over a period of 6 months.
  • Exclusion Criteria:
  • All children who are already walking at presentation; All children with previous treatment; All children who have used FAB previously; All children treated with surgery other than tenotomy; All children with syndromic or neuropathic cases of clubfoot; All children with atypical clubfoot.

About Miraclefeet

MiracleFeet is a nonprofit organization dedicated to improving the lives of children with clubfoot, a common congenital condition that can lead to lifelong mobility issues if left untreated. Through innovative treatment protocols, community engagement, and partnerships with local healthcare providers, MiracleFeet aims to ensure that children worldwide have access to effective and affordable care. The organization's commitment to research and clinical trials seeks to enhance treatment methodologies and outcomes, ultimately striving to create a future where every child with clubfoot can walk, run, and thrive.

Locations

Mumbai, Maharashtra, India

Patients applied

0 patients applied

Trial Officials

Alaric Aroojis, MD

Principal Investigator

Bai Jerbai Wadia Hospital for Children

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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