An interventional study of Foot abduction bracing for clubfoot with novel Dynamic Bar and Foot abduction bracing for clubfoot with Standard Bar in Clubfoot, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 1 Year to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Device feasibility
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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:
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.
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.
69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.
This study's enrollment of 17 is below the median of 38 across 40 interventional studies indexed under Clubfoot.
Browse Clubfoot studies →The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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.
Recruitment of Patients for a Prospective Trial Comparing Clubfoot Brace Types
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.
Time frame: Recruitment period lasted approximately 8 months.
Retention of Patients for a Prospective Trial Comparing Clubfoot Brace Types
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.
Time frame: Study period lasted approximately 90 days.
Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types
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.
Time frame: Study period lasted approximately 90 days.
Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar
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.
Time frame: Study period lasted approximately 90 days.
Parental Perception of Child Comfort - Preferred Bar
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.
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).
Parental Perception of Child Comfort - If Child Had a Hard Time Returning to the Standard Bar After Wearing the Dynamic Bar
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.
Time frame: Study period lasted approximately 90 days.
Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses
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.
Time frame: Intervention period lasted approximately 30 days.
Patient Tolerance of Bracing - Experimental Arm vs. Control Arm - Overall Average
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
Time frame: Intervention period lasted approximately 30 days.
Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - Overall Average
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.
Time frame: 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
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.
Time frame: 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
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).
Time frame: Study period lasted approximately 90 days.
Video Data Analysis - Comparing the Range of Motion Provided by the Dynamic Bar vs. Standard Bar
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.
Time frame: Each video recording was approximately 2 minutes in length.
Participants were recruited at the Clubfoot Clinic in the Hospital for Sick Children between August 2022 and March 2023. The first participant was enrolled on August 17, 2022, and the last participant was enrolled on February 15, 2023.
| Milestone | Control Arm | Experimental Arm |
|---|---|---|
| Started | 5 | 7 |
| Completed | 4 | 7 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| Participants | Expected Number of Patients Recruited | Actual Number of Patients Recruited |
|---|---|---|
| Recruitment of Patients for a Prospective Trial Comparing Clubfoot Brace Types | 59 | 17 |
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.
| Participants | Expected Number of Dropouts | Actual Number of Dropouts |
|---|---|---|
| Retention of Patients for a Prospective Trial Comparing Clubfoot Brace Types | 0 | 6 |
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.
| Participants | Control Arm | Experimental Arm |
|---|---|---|
| First day: Parents asked if they had concerns about participating in the study. — Strongly Disagree | 1 | 3 |
| First day: Parents asked if they had concerns about participating in the study. — Disagree | 3 | 4 |
| First day: Parents asked if they had concerns about participating in the study. — Unsure | 0 | 0 |
| First day: Parents asked if they had concerns about participating in the study. — Agree | 0 | 0 |
| First day: Parents asked if they had concerns about participating in the study. — Strongly Agree | 0 | 0 |
| Last day: Parents asked if they would be interested in participating in a future study. — Strongly Disagree | 0 | 0 |
| Last day: Parents asked if they would be interested in participating in a future study. — Disagree | 0 | 0 |
| Last day: Parents asked if they would be interested in participating in a future study. — Unsure | 0 | 1 |
| Last day: Parents asked if they would be interested in participating in a future study. — Agree | 2 | 1 |
| Last day: Parents asked if they would be interested in participating in a future study. — Strongly Agree | 2 | 5 |
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.
| Participants | Experimental Arm |
|---|---|
| Much less comfortable | 0 |
| Less comfortable | 0 |
| Equally comfortable | 0 |
| More comfortable | 4 |
| Much more comfortable | 3 |
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.
| Participants | Experimental Arm |
|---|---|
| Parent asked to indicate their preferred bar at the end of the study's intervention period. — Standard Bar | 0 |
| Parent asked to indicate their preferred bar at the end of the study's intervention period. — Unsure | 2 |
| Parent asked to indicate their preferred bar at the end of the study's intervention period. — Dynamic Bar | 5 |
| Parent asked to indicate their preferred bar at the end of the study's intervention period. — Other | 0 |
| Parent asked to indicate their preferred bar on the last day of the study. — Standard Bar | 0 |
| Parent asked to indicate their preferred bar on the last day of the study. — Unsure | 1 |
| Parent asked to indicate their preferred bar on the last day of the study. — Dynamic Bar | 6 |
| Parent asked to indicate their preferred bar on the last day of the study. — Other | 0 |
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.
| Participants | Experimental Arm |
|---|---|
| Strongly Disagree | 2 |
| Disagree | 2 |
| Unsure | 1 |
| Agree | 2 |
| Strongly Agree | 0 |
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.
| score on a scale | Experimental Arm Using Standard Bar | Experimental Arm Using Dynamic Bar |
|---|---|---|
| Child comfort in bar | 4.3 (3 to 5) | 4.6 (4 to 5) |
| Ability to move feet/legs normally in bar | 3.4 (1 to 5) | 4.4 (3 to 5) |
| Parent satisfaction with weight of bar | 4.0 (3 to 5) | 3.9 (2 to 5) |
| Parent satisfaction with shape of bar | 3.9 (3 to 5) | 4.3 (3 to 5) |
| Parent satisfaction with size of bar | 3.9 (2 to 5) | 4.6 (4 to 5) |
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
| Average Adherence Fraction | Control Arm | Experimental Arm |
|---|---|---|
| Parent-reported brace logs | 1.01 ± 0.14 | 0.97 ± 0.06 |
| iButton temperature sensors | 1.03 ± 0.15 | 0.91 ± 0.07 |
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.
| Average Adherence Fraction | Experimental Arm Using the Standard Bar | Experimental Arm Using the Dynamic Bar |
|---|---|---|
| Parent-reported brace logs | 0.96 ± 0.09 | 0.97 ± 0.06 |
| iButton temperature sensors | 0.78 ± 0.24 | 0.91 ± 0.07 |
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.
| Participants | Experimental Arm - Wore the Standard Bar More Than the Dynamic Bar | Experimental Arm - Wore the Dynamic Bar More Than the Standard Bar |
|---|---|---|
| Parent-reported brace logs | 2 | 3 |
| iButton temperature sensors | 2 | 5 |
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).
| Participants | Control Arm | Experimental Arm |
|---|---|---|
| All patients | 2 | 0 |
| Patients with fair brace compliance per logs and sensors (+/- 1 hr of the prescribed range per day) | 1 | 0 |
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.
| Participants | Control Arm Using Standard Bar | Experimental Arm Using Dynamic Bar |
|---|---|---|
| Patients that were noted to achieve normal developmental motor skills during video recording. | 4 | 7 |
| Patients that were noted to achieve intermittent ankle plantarflexion during video recording. | 1 | 2 |
To refine the design of the Dynamic Bar prototype for future use, the study team documented all bar breakages/malfunctions that occurred during the study period.
| cases observed | Breakages and Malfunctions of the Dynamic Bar |
|---|---|
| Participant pinched their finger in the pin-slot mechanism (this prompted immediate bar redesign) | 1 |
| Ball joint popped out of socket in ball joint linkage (this prompted immediate bar redesign) | 3 |
| End caps on the L brackets were torn by the participant | 2 |
| Crossbar snapped in two | 1 |
| Wear was observed on the brass components in the ball joint linkages | 6 |
Collected over Adverse Event (AE) data was collected at each study visit over the entire study period, which lasted for approximately 3 months per participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Arm Using Standard Bar | 0/4 (0%) | 0/4 (0%) | 3/4 (75%) |
| Experimental Arm Using Experimental Bar Then Standard Bar | 0/7 (0%) | 0/7 (0%) | 4/7 (57.1%) |
| Event | Control Arm Using Standard Bar | Experimental Arm Using Experimental Bar Then Standard Bar |
|---|---|---|
| Pressure sore, skin rash, and/or rednessSkin and subcutaneous tissue disorders | 2/4 | 3/7 |
| Development of mild MTP adductionMusculoskeletal and connective tissue disorders | 1/4 | 1/7 |
| Development of mild dynamic supinationMusculoskeletal and connective tissue disorders | 1/4 | 0/7 |
| Decreased eversion strengthMusculoskeletal and connective tissue disorders | 1/4 | 0/7 |
| Decreased passive dorsiflexionMusculoskeletal and connective tissue disorders | 1/4 | 0/7 |
| Decreased external foot progression angleMusculoskeletal and connective tissue disorders | 1/4 | 0/7 |
| Pinched finger in foot abduction barProduct Issues | 0/4 | 1/7 |
| Age, Continuous(months) | Control Arm | Experimental Arm | Total |
|---|---|---|---|
| Mean | 24.9 (16 to 36) | 27.6 (15.5 to 46.5) | 26.6 (15.5 to 46.5) |
| Sex: Female, Male(Participants) | Control Arm | Experimental Arm | Total |
|---|---|---|---|
| Female | 0 | 2 | 2 |
| Male | 4 | 5 | 9 |
| Race and Ethnicity Not Collected(Participants) | Control Arm | Experimental Arm | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Diagnosis(Participants) | Control Arm | Experimental Arm | Total |
|---|---|---|---|
| Unilateral idiopathic clubfoot | 3 | 5 | 8 |
| Bilateral idiopathic clubfoot | 1 | 2 | 3 |
| Height(cm) | Control Arm | Experimental Arm | Total |
|---|---|---|---|
| Mean | 87.7 (81.5 to 95) | 89.9 (80.5 to 105) | 89.1 (80.5 to 105) |
| Weight(kg) | Control Arm | Experimental Arm | Total |
|---|---|---|---|
| Mean | 13.5 (11 to 15.8) | 13.9 (10.8 to 19.9) | 13.8 (10.8 to 19.9) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — We do not plan on sharing this data with other researchers.
Ran from Aug 2022 to primary completion in May 2023, 9 months.
Results were first posted in Nov 2024, 1 year 6 months after primary completion.
Of 20 interventional studies with no phase under Clubfoot, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's 9 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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