NCT05293743

Novel Dynamic Foot Abduction Bar for Treatment of Clubfoot

Completed NA Results posted Last updated 22 May 2025

What this trial tests

NA trial testing Foot abduction bracing for clubfoot with novel Dynamic Bar in Clubfoot in 17 participants. Completed in 24 May 2023.

Timeline

17 August 2022

Primary endpoint
24 May 2023

24 May 2023

Quick facts

Lead sponsor	The Hospital for Sick Children
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	device feasibility
Enrollment	17
Start date	17 August 2022
Primary completion	24 May 2023
Estimated completion	24 May 2023
Sites	1 location across Canada

Drugs / interventions tested

• Foot abduction bracing for clubfoot with novel Dynamic Bar
• Foot abduction bracing for clubfoot with Standard Bar

Conditions studied

• Clubfoot — all drugs for Clubfoot →

Sponsor

The Hospital for Sick Children

Who can join

Adults 1 to 3, any sex, with Clubfoot. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Recruitment of Patients for a Prospective Trial Comparing Clubfoot Brace Types Primary · 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.

Group	Value	95% CI
Expected Number of Patients Recruited	59
Actual Number of Patients Recruited	17

Retention of Patients for a Prospective Trial Comparing Clubfoot Brace Types Primary · 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.

Group	Value	95% CI
Expected Number of Dropouts	0
Actual Number of Dropouts	6

Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types Primary · 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.

First day: Parents asked if they had concerns about participating in the study.

Group	Value	95% CI
Control Arm	1
Experimental Arm	3
Control Arm	3
Experimental Arm	4
Control Arm	0
Experimental Arm	0
Control Arm	0
Experimental Arm	0

Last day: Parents asked if they would be interested in participating in a future study.

Group	Value	95% CI
Control Arm	0
Experimental Arm	0
Control Arm	0
Experimental Arm	0
Control Arm	0
Experimental Arm	1
Control Arm	2
Experimental Arm	1

Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar Secondary · 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.

Group	Value	95% CI
Experimental Arm	0
Experimental Arm	0
Experimental Arm	0
Experimental Arm	4

Parental Perception of Child Comfort - Preferred Bar Secondary · 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.

Parent asked to indicate their preferred bar at the end of the study's intervention period.

Group	Value	95% CI
Experimental Arm	0
Experimental Arm	2
Experimental Arm	5
Experimental Arm	0

Parent asked to indicate their preferred bar on the last day of the study.

Group	Value	95% CI
Experimental Arm	0
Experimental Arm	1
Experimental Arm	6
Experimental Arm	0

Parental Perception of Child Comfort - If Child Had a Hard Time Returning to the Standard Bar After Wearing the Dynamic Bar Secondary · 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.

Group	Value	95% CI
Experimental Arm	2
Experimental Arm	2
Experimental Arm	1
Experimental Arm	2

Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses Secondary · 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

Child comfort in bar

Group	Value	95% CI
Experimental Arm Using Standard Bar	4.3	3 – 5
Experimental Arm Using Dynamic Bar	4.6	4 – 5

Ability to move feet/legs normally in bar

Group	Value	95% CI
Experimental Arm Using Standard Bar	3.4	1 – 5
Experimental Arm Using Dynamic Bar	4.4	3 – 5

Parent satisfaction with weight of bar

Group	Value	95% CI
Experimental Arm Using Standard Bar	4.0	3 – 5
Experimental Arm Using Dynamic Bar	3.9	2 – 5

Parent satisfaction with shape of bar

Group	Value	95% CI
Experimental Arm Using Standard Bar	3.9	3 – 5
Experimental Arm Using Dynamic Bar	4.3	3 – 5

Parent satisfaction with size of bar

Group	Value	95% CI
Experimental Arm Using Standard Bar	3.9	2 – 5
Experimental Arm Using Dynamic Bar	4.6	4 – 5

Patient Tolerance of Bracing - Experimental Arm vs. Control Arm - Overall Average Secondary · 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

Parent-reported brace logs

Group	Value	95% CI
Control Arm	1.01	± 0.14
Experimental Arm	0.97	± 0.06

iButton temperature sensors

Group	Value	95% CI
Control Arm	1.03	± 0.15
Experimental Arm	0.91	± 0.07

Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - Overall Average Secondary · 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 o

Parent-reported brace logs

Group	Value	95% CI
Experimental Arm Using the Standard Bar	0.96	± 0.09
Experimental Arm Using the Dynamic Bar	0.97	± 0.06

iButton temperature sensors

Group	Value	95% CI
Experimental Arm Using the Standard Bar	0.78	± 0.24
Experimental Arm Using the Dynamic Bar	0.91	± 0.07

Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - N of 1 Secondary · 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 o

Parent-reported brace logs

Group	Value	95% CI
Experimental Arm - Wore the Standard Bar More Than the Dynamic Bar	2
Experimental Arm - Wore the Dynamic Bar More Than the Standard Bar	3

iButton temperature sensors

Group	Value	95% CI
Experimental Arm - Wore the Standard Bar More Than the Dynamic Bar	2
Experimental Arm - Wore the Dynamic Bar More Than the Standard Bar	5

Number of Clubfoot Recurrences During the Study Period Secondary · 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 omitte

All patients

Group	Value	95% CI
Control Arm	2
Experimental Arm	0

Patients with fair brace compliance per logs and sensors (+/- 1 hr of the prescribed range per day)

Group	Value	95% CI
Control Arm	1
Experimental Arm	0

Video Data Analysis - Comparing the Range of Motion Provided by the Dynamic Bar vs. Standard Bar Secondary · 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.

Patients that were noted to achieve normal developmental motor skills during video recording.

Group	Value	95% CI
Control Arm Using Standard Bar	4
Experimental Arm Using Dynamic Bar	7

Patients that were noted to achieve intermittent ankle plantarflexion during video recording.

Group	Value	95% CI
Control Arm Using Standard Bar	1
Experimental Arm Using Dynamic Bar	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Event (AE) data was collected at each study visit over the entire study period, which lasted for approximately 3 months per participant.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control Arm Using Standard Bar

Serious: 0/4 (0%)

Deaths: 0/4

Experimental Arm Using Experimental Bar Then Standard Bar

Serious: 0/7 (0%)

Deaths: 0/7

Other adverse events (7 terms — click to expand)

Reaction	System	Control Arm Using Standard…	Experimental Arm Using Exp…
Pressure sore, skin rash, and/or redness	Skin and subcutaneous tissue disorders	—	—
Pinched finger in foot abduction bar	Product Issues	—	—
Development of mild MTP adduction	Musculoskeletal and connective tissue disorders	—	—
Development of mild dynamic supination	Musculoskeletal and connective tissue disorders	—	—
Decreased eversion strength	Musculoskeletal and connective tissue disorders	—	—
Decreased passive dorsiflexion	Musculoskeletal and connective tissue disorders	—	—
Decreased external foot progression angle	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT05293743 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.