Status:
COMPLETED
Novel Dynamic Foot Abduction Bar for Treatment of Clubfoot
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Clubfoot
Eligibility:
All Genders
1-3 years
Phase:
NA
Brief 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 ...
Detailed Description
This is an assessor-blinded randomized feasibility trial assessing the feasibility of conducting a large-scale clinical trial to evaluate the effectiveness of a new dynamic bar for foot abduction brac...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Recurrent clubfoot deformity at time of recruitment and/or Day 0 in study period: Pirani score above 0.5; Presence of cavus, adduction, or hindfoot varus; Less than 10 degrees of passive ankle dorsiflexion.
- Current complaint of significant brace intolerance.
- Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk, i.e., skin conditions such as eczema, neurologic conditions or any non-idiopathic clubfoot, any acute or chronic illness perceived to be causing the child discomfort such as a cold or flu or other concurrent painful procedure.
- The patient does not adequately fit the available prototype, e.g., shoulder width distance is too narrow or wide for prototype bar width. However, these patients will be recorded in the study enrollment log to identify the size of this subset. The age and fit issues of these patients will also be recorded to allow future adaptations of the new DB to accommodate this subset.
- The patient is using an older boot model, in which a temperature sensor cannot be inserted, and the patient does not adequately fit the available boots, in which the temperature sensors have already been installed.
Key Trial Info
Start Date :
August 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05293743
Start Date
August 17 2022
End Date
May 24 2023
Last Update
May 22 2025
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8