Novel Dynamic Foot Abduction Bar for Treatment of Clubfoot

May 20, 2025 updated by: Maryse Bouchard, The Hospital for Sick Children

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Bar
This group will continue using the Standard Bar as part of their brace, per their current treatment.
Device: Foot abduction bracing for clubfoot with Standard 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.
Experimental: Dynamic Bar
This group will use the Dynamic Bar for 30 days instead of their Standard Bar.
Device: Foot abduction bracing for clubfoot with novel 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 Dynamic Bar.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment of Patients for a Prospective Trial Comparing Clubfoot Brace Types
Time Frame: Recruitment period lasted approximately 8 months.
The study's recruitment rate was calculated to evaluate the ease of recruiting participants for a randomized-controlled effectiveness trial of a novel foot abduction bar. A recruitment rate less than 50% is considered a poor indicator for ease of recruitment and protocols for a future study should be revisited to improve recruitment strategies.
Recruitment period lasted approximately 8 months.
Retention of Patients for a Prospective Trial Comparing Clubfoot Brace Types
Time Frame: Study period lasted approximately 90 days.
The dropout rate was calculated to evaluate the ease of retaining participants for a randomized-controlled effectiveness trial of a novel FAB bar. A dropout rate greater than 20% is considered a poor indicator for ease of participant retention.
Study period lasted approximately 90 days.
Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types
Time Frame: Study period lasted approximately 90 days.

On the first day of the study, parents were asked in a questionnaire if they had any concerns about participating in the study. On the last day of the study, parents were asked if they would be interested in participating in a future study of the Dynamic Bar.

These questions were asked to evaluate the ease of achieving parent satisfaction during a randomized-controlled effectiveness trial of a novel FAB bar.
Study period lasted approximately 90 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar
Time Frame: Study period lasted approximately 90 days.
On the last day of the study, parents in the experimental arm were asked in a questionnaire how they thought the Dynamic Bar compared to their original bar, regarding their child's comfort. This was asked to compare parental perception of child comfort in the Dynamic Bar to the Standard Bar.
Study period lasted approximately 90 days.
Parental Perception of Child Comfort - Preferred Bar
Time Frame: 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).
Parents in the experimental arm were asked to indicate their preferred bar for clubfoot bracing at two different points during the study. This was asked to compare parental perception of child comfort in the Dynamic Bar to the Standard Bar.
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).
Parental Perception of Child Comfort - If Child Had a Hard Time Returning to the Standard Bar After Wearing the Dynamic Bar
Time Frame: Study period lasted approximately 90 days.
On the last day of the study period, parents in the experimental arm were asked in a questionnaire if their child had a hard time returning to the Standard Bar after wearing the Dynamic Bar for approximately 30 days. This was asked to compare parental perception of child comfort in the Dynamic Bar to the Standard Bar.
Study period lasted approximately 90 days.
Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses
Time Frame: Intervention period lasted approximately 30 days.

On the first day of the study period, parents in the experimental arm were asked about their child's comfort in the Standard Bar, their child's ability to move their feet/legs normally in the Standard Bar, and their satisfaction with the weight, shape, and size of the Standard Bar.

Following the study's intervention period, parents in the experimental arm were asked the same questions about the Dynamic Bar.

Average survey responses were then compared in order to compare parental perception of child comfort in the Dynamic Bar to the Standard Bar.

Possible survey answers ranged from strongly disagree/very unsatisfied (1) to strongly agree/very satisfied (5). A higher score indicates a more positive perception of the bar.
Intervention period lasted approximately 30 days.
Patient Tolerance of Bracing - Experimental Arm vs. Control Arm - Overall Average
Time Frame: Intervention period lasted approximately 30 days.

Each patient's brace wear was recorded by parent-report brace logs and iButton temperature sensors in order to compare patient tolerance of the Standard Bar to the Dynamic Bar. For each patient, a bracing adherence fraction was calculated by dividing their average number of daily bracing hours by their prescribed number of daily bracing hours.

The average adherence fraction in the experimental arm was compared to the average adherence fraction in the control arm during the study's intervention period. Under normal circumstances, the intervention period was the time between the patient's Day 0 visit and Day 30 visit, as that is the period in which patients in the experimental arm should be wearing the Dynamic Bar. However, if a patient in the experimental arm broke the Dynamic Bar and had to return to the Standard Bar during this period, those days were not included in the intervention period.

This analysis aims to assess if bar type significantly affects bracing tolerance
Intervention period lasted approximately 30 days.
Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - Overall Average
Time Frame: Experimental arm used the Dynamic Bar for approximately 30 days, then used the Standard Bar for approximately 60 days

Each patient's brace wear was recorded by parent-report brace logs and iButton temperature sensors in order to compare patient tolerance of the Standard Bar to the Dynamic Bar. For each patient, a bracing adherence fraction was calculated by dividing their average number of daily bracing hours by their prescribed number of daily bracing hours.

Since patients in the experimental arm used both the Dynamic Bar and the Standard Bar during the study period, their average adherence fraction when wearing the Dynamic Bar was compared to their average adherence fraction when wearing the Standard Bar over the entire study period.

This analysis aims to assess if bar type significantly affects bracing tolerance.
Experimental arm used the Dynamic Bar for approximately 30 days, then used the Standard Bar for approximately 60 days
Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - N of 1
Time Frame: Experimental arm used the Dynamic Bar for approximately 30 days, then used the Standard Bar for approximately 60 days

Each patient's brace wear was recorded by parent-report brace logs and iButton temperature sensors in order to compare patient tolerance of the Standard Bar to the Dynamic Bar. For each patient, a bracing adherence fraction was calculated by dividing their average number of daily bracing hours by their prescribed number of daily bracing hours.

Since patients in the experimental arm used both the Dynamic Bar and the Standard Bar during the study period, their average adherence fraction when wearing the Dynamic Bar was compared to their average adherence fraction when wearing the Standard Bar over the entire study period.

This analysis aims to assess if bar type significantly affects bracing tolerance.
Experimental arm used the Dynamic Bar for approximately 30 days, then used the Standard Bar for approximately 60 days
Number of Clubfoot Recurrences During the Study Period
Time Frame: Study period lasted approximately 90 days.

All clubfoot recurrences that occurred during the study period were tracked to perform a preliminary assessment of the effectiveness of the Dynamic Bar at preventing clubfoot recurrence.

For this analysis, clubfoot recurrence was pre-defined as a Pirani score > 0.5, a new occurrence of cavus, adduction and/or hindfoot varus, or a loss of passive ankle dorsiflexion (equinus) of < 10 degrees above neutral or a reduction of 5 or more degrees from the previous visit. All adverse adverse events that were deemed "unrelated" to the foot abduction bar, per the blinded outcomes assessor, were omitted from this analysis.

The null hypothesis is that 'the Dynamic Bar does not lead to higher rates of clubfoot recurrence,' and it will be rejected if the number of patients who wore their FAB as prescribed and develop clubfoot recurrence, is substantially greater in the experimental arm than it is in the control arm (i.e. a difference of more than 2 cases).
Study period lasted approximately 90 days.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Video Data Analysis - Comparing the Range of Motion Provided by the Dynamic Bar vs. Standard Bar
Time Frame: Each video recording was approximately 2 minutes in length.
Parents were given the option of consenting to video recordings being taken of the patient's feet and legs while wearing their prescribed bar. These videos were closely studied to compare the range of motion provided by the Standard Bar to the Dynamic Bar, and to verify that the Dynamic Bar consistently maintains proper foot position and leg alignment during use.
Each video recording was approximately 2 minutes in length.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Maryse Bouchard, MD, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2022

Primary Completion (Actual)

May 24, 2023

Study Completion (Actual)

May 24, 2023

Study Registration Dates

First Submitted

October 31, 2021

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000078967

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan on sharing this data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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