Clinical trial NCT05293743: Novel Dynamic Foot Abduction Bar for Treatment of Clubfoot
Official title: Development and Evaluation of Novel Dynamic Bar for Foot Abduction Brace for Clubfoot Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clubfoot
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 17
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental arm with new device, control arm with standard device.
Primary purpose: DEVICE_FEASIBILITY

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 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.

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 bracing for clubfoot treatment. Feasibility will be determined by the ability to recruit patients within the goal study period and to retain participants. Eligible patients must have a well-corrected idiopathic clubfoot (Pirani Score ≤ 0.5) and be in the minimum 12 hours per day bracing stage of the Ponseti clubfoot treatment protocol. The overall study period will be 90 days in length. For the first 30 days, the experimental cohort will wear the new Dynamic Bar (DB) with standard ankle-foot orthoses (boots) and the control cohort will continue wearing their Standard Bar (SB). After this 30-day period, the experimental cohort will return to wearing their SB.

All patients will be evaluated on Day 0, Day 7, Day 30, and Day 90 of the study period to monitor for recurrence of the clubfoot deformity, complications of brace wearing, to submit brace wear logs, and to complete parent-reported questionnaires regarding their perceptions of the Foot Abduction Brace (FAB) and their child's comfort. A minimum of 10 patients per arm will be recruited. A temperature sensor will be added in each participant's boots during the 90-day study period to objectively measure time of brace wear. It is hypothesized that when patients are wearing the DB, they will experience higher brace tolerance defined as increased wear time of the brace as measured by the temperature sensors, and higher comfort levels as reported by parents, without an increase in clubfoot deformity recurrence compared to the SB.

Most patient information that will be reviewed in this study is data being collected and stored per the REB-approved Clubfoot Research Registry protocol (REB #1000053919). All patients enrolled in study this will also be enrolled in Clubfoot Research Registry, if not already enrolled.

The novel DB is designed by the research team and allows independent movement of the knees and hips while maintaining a corrective position of the foot.

Eligibility criteria: Inclusion Criteria:

1. Ability of parent/care giver to complete brace wear log/surveys in English
2. Diagnosis of idiopathic clubfoot (unilateral or bilateral).
3. Current use of a SB with their Foot Abduction Brace.
4. In the minimum 12-hour per day bracing stage of the Ponseti treatment
5. 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).
6. Well-corrected clubfoot/clubfeet (Pirani score ≤ 0.5)
7. Enrollment in the SickKids Clubfoot Research Registry.

Exclusion Criteria:

1. 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.
2. Current complaint of significant brace intolerance.
3. 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.
4. 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.
5. 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.

Primary outcomes:
measure: Recruitment of Patients for a Prospective Trial Comparing Clubfoot Brace Types
timeFrame: Recruitment period lasted approximately 8 months.
measure: Retention of Patients for a Prospective Trial Comparing Clubfoot Brace Types
timeFrame: Study period lasted approximately 90 days.
measure: Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types
timeFrame: Study period lasted approximately 90 days.
Secondary outcomes:
measure: Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar
timeFrame: Study period lasted approximately 90 days.
measure: Parental Perception of Child Comfort - Preferred Bar
timeFrame: Parents were asked to indicate their preferred bar for clubfoot bracing at the end of the study's intervention period (after approximately 30 days) and on the last day of the study (after approximately 90 days).
measure: Parental Perception of Child Comfort - If Child Had a Hard Time Returning to the Standard Bar After Wearing the Dynamic Bar
timeFrame: Study period lasted approximately 90 days.
measure: Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses
timeFrame: Intervention period lasted approximately 30 days.
measure: Patient Tolerance of Bracing - Experimental Arm vs. Control Arm - Overall Average
timeFrame: Intervention period lasted approximately 30 days.
measure: Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - Overall Average
timeFrame: Experimental arm used the Dynamic Bar for approximately 30 days, then used the Standard Bar for approximately 60 days
measure: Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - N of 1
timeFrame: Experimental arm used the Dynamic Bar for approximately 30 days, then used the Standard Bar for approximately 60 days
measure: Number of Clubfoot Recurrences During the Study Period
timeFrame: Study period lasted approximately 90 days.
Other outcomes:
measure: Video Data Analysis - Comparing the Range of Motion Provided by the Dynamic Bar vs. Standard Bar
timeFrame: Each video recording was approximately 2 minutes in length.
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Maryse Bouchard, MD
role: PRINCIPAL_INVESTIGATOR
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