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

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.