At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Development and Evaluation of Novel Dynamic Bar for Foot Abduction Brace for Clubfoot Treatment
In Brief
A clinical study evaluating Foot abduction bracing for clubfoot with novel Dynamic Bar and Foot abduction bracing for clubfoot with Standard Bar for Clubfoot. Completed, enrolled 17 participants across 1 site.
Detailed Summary
The goal of this clinical trial is to evaluate a new Dynamic Bar for foot abduction bracing for clubfoot treatment. The main questions that this study aims to answer are: * How easy is it to recruit and retain participants for a randomized-controlled effectiveness trial of a novel foot abduction bar? * How does parental perception of child comfort in the Dynamic Bar compare to parental perception of child comfort in standard bars? * How does patient tolerance of the Dynamic Bar compare patient tolerance of standard bars? * How effective is the Dynamic Bar at preventing clubfoot recurrence during the bracing phase when the brace is worn as prescribed for a 30-day trial period? Each participant will be randomized into one of two arms: the experimental arm or the control arm. For the first 30 days, the experimental arm will wear the new Dynamic Bar with standard boots and the control arm will continue wearing their standard bar. After this 30-day period, the experimental arm will return to wearing their standard bar.
Study Details
Timeline
Interventions
After Ponseti treatment of serial casting and tenotomy for clubfoot, patients are braced full time x 3 months then night time until age 5. This study compares standard bars in a foot abduction brace to our novel Dynamic Bar. This group uses the Dynamic Bar.
After Ponseti treatment of serial casting and tenotomy for clubfoot, patients are braced full time x 3 months then night time until age 5. This study compares standard bars in a foot abduction brace to our novel Dynamic Bar. This group uses the Standard Bar.