N/A
N=12
Novel Dynamic Foot Abduction Bar for Treatment of Clubfoot
Clubfoot
Bottom Line
View on ClinicalTrials.gov: NCT05293743 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Recruitment of Patients for a Prospective Trial Comparing Clubfoot Brace Types — 59; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Foot abduction bracing for clubfoot with novel Dynamic Bar (Device); Foot abduction bracing for clubfoot with Standard Bar (Device)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- The Hospital for Sick Children
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment of Patients for a Prospective Trial Comparing Clubfoot Brace Types |
59; 17 | — |
| PRIMARY Retention of Patients for a Prospective Trial Comparing Clubfoot Brace Types |
0; 6 | — |
| PRIMARY Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types |
1; 3; 3; 4; 0; 0 | — |
| SECONDARY Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar |
0; 0; 0; 4; 3 | — |
| SECONDARY Parental Perception of Child Comfort - Preferred Bar |
0; 2; 5; 0; 0; 1 | — |
| SECONDARY Parental Perception of Child Comfort - If Child Had a Hard Time Returning to the Standard Bar After Wearing the Dynamic Bar |
2; 2; 1; 2; 0 | — |
| SECONDARY Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses |
4.3; 4.6; 3.4; 4.4; 4.0; 3.9 | — |
| SECONDARY Patient Tolerance of Bracing - Experimental Arm vs. Control Arm - Overall Average |
1.01; 0.97; 1.03; 0.91 | 0.67 |
| SECONDARY Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - Overall Average |
0.96; 0.97; 0.78; 0.91 | 0.86 |
| SECONDARY Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - N of 1 |
2; 3; 2; 5 | — |
| SECONDARY Number of Clubfoot Recurrences During the Study Period |
2; 0; 1; 0 | — |
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 Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05293743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.