Development and Evaluation of Novel Dynamic Bar for Foot Abduction Brace for Clubfoot Treatment

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 3
Healthy Volunteers: t
View:

• Ability of parent/care giver to complete brace wear log/surveys in English

• Diagnosis of idiopathic clubfoot (unilateral or bilateral).

• Current use of a SB with their Foot Abduction Brace.

• In the minimum 12-hour per day bracing stage of the Ponseti treatment

• Aged 1 to 3 years (as the DB prototype was designed based on the average size and strength of a child within that age group).

• Well-corrected clubfoot/clubfeet (Pirani score ≤ 0.5)

• Enrollment in the SickKids Clubfoot Research Registry.

Locations
Other Locations
Canada
The Hospital for Sick Children
Toronto
Time Frame
Start Date: 2022-08-17
Completion Date: 2023-05-24
Participants
Target number of participants: 17
Treatments
Active_comparator: Standard Bar
This group will continue using the Standard Bar as part of their brace, per their current treatment.
Experimental: Dynamic Bar
This group will use the Dynamic Bar for 30 days instead of their Standard Bar.
Related Therapeutic Areas
Sponsors
Leads: The Hospital for Sick Children

This content was sourced from clinicaltrials.gov

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