ClubfootNCT05293743
Novel Dynamic Foot Abduction Bar for Treatment of Clubfoot
A study testing Foot abduction bracing for clubfoot with novel Dynamic Bar and Foot abduction bracing for clubfoot with Standard Bar in people with Clubfoot, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Clubfoot
- What is being tested?
- Foot abduction bracing for clubfoot with novel Dynamic Bar and Foot abduction bracing for clubfoot with Standard Bar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 17 Aug 2022to 24 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Clubfoot
- Being tested
- Foot abduction bracing for clubfoot with novel Dynamic Bar, Foot abduction bracing for clubfoot with Standard Bar
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot abduction bracing for clubfoot with novel Dynamic BarDevice
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.
Foot abduction bracing for clubfoot with Standard BarDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Bar | Active comparator | This group will continue using the Standard Bar as part of their brace, per their current treatment. Receives: Device: Foot abduction bracing for clubfoot with Standard Bar |
| Dynamic Bar | Experimental | This group will use the Dynamic Bar for 30 days instead of their Standard Bar. Receives: Device: Foot abduction bracing for clubfoot with novel Dynamic Bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Study period lasted approximately 90 days.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Study period lasted approximately 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start17 Aug 2022
- Primary completion24 May 2023
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for ClubfootStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental arm with new device, control arm with standard device.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryse Bouchard, The Hospital for Sick Children
- Investigators
- Maryse Bouchard, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293743
- Sponsor's protocol ID
- 1000078967
- Status last verified
- May 2025
- First submitted
- 31 Oct 2021
- Last updated
- 22 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan on sharing this data with other researchers.
Publications
Anand A, Sala DA. Clubfoot: etiology and treatment. Indian J Orthop. 2008 Jan;42(1):22-8. doi: 10.4103/0019-5413.38576.
PubMed 19823650Alves C. Bracing in clubfoot: do we know enough? J Child Orthop. 2019 Jun 1;13(3):258-264. doi: 10.1302/1863-2548.13.190069.
PubMed 31312265Hospital for Special Surgery [Internet]. New York: HSS. Method for Correcting Clubfoot: Overview for Parent; 2019 Sept 12 [cited 2021 Jan 11] Available from: https://www.hss.edu/conditions_thse-ponseti-method-for-clubfoot-correction.asp.
Garg S, Porter K. Improved bracing compliance in children with clubfeet using a dynamic orthosis. J Child Orthop. 2009 Aug;3(4):271-6. doi: 10.1007/s11832-009-0182-9. Epub 2009 Jun 3.
PubMed 19495824SickKids Internal Document. CLUBFOOT FAO BAR OPTIONS June 2017 edited. 2017 June.
Azarpira MR, Emami MJ, Vosoughi AR, Rahbari K. Factors associated with recurrence of clubfoot treated by the Ponseti method. World J Clin Cases. 2016 Oct 16;4(10):318-322. doi: 10.12998/wjcc.v4.i10.318.
PubMed 27803913Zhao D, Liu J, Zhao L, Wu Z. Relapse of clubfoot after treatment with the Ponseti method and the function of the foot abduction orthosis. Clin Orthop Surg. 2014 Sep;6(3):245-52. doi: 10.4055/cios.2014.6.3.245. Epub 2014 Aug 5.
PubMed 25177447American Academy of Orthopaedic Surgeons [Internet]. Illinois: AAOS. Study Finds Ponseti Method Remains an Effective Treatment for Clubfoot, Bracing Is Paramount; 2021 Jan 18 [cited 2021 May 25] Available from: https://www.aaos.org/aaosnow/2020/aaos-now-special-edition/research/662_pediatrics.
Gelfer Y, Wientroub S, Hughes K, Fontalis A, Eastwood DM. Congenital talipes equinovarus: a systematic review of relapse as a primary outcome of the Ponseti method. Bone Joint J. 2019 Jun;101-B(6):639-645. doi: 10.1302/0301-620X.101B6.BJJ-2018-1421.R1.
PubMed 31154846Morgenstein A, Davis R, Talwalkar V, Iwinski H Jr, Walker J, Milbrandt TA. A randomized clinical trial comparing reported and measured wear rates in clubfoot bracing using a novel pressure sensor. J Pediatr Orthop. 2015 Mar;35(2):185-91. doi: 10.1097/BPO.0000000000000205.
PubMed 24787312Aroojis A, Pandey T, Dusa A, Krishnan AG, Ghyar R, Ravi B. Development of a functional prototype of a SMART (Sensor-integrated for Monitoring And Remote Tracking) foot abduction brace for clubfoot treatment: a pre-clinical evaluation. Int Orthop. 2021 Sep;45(9):2401-2410. doi: 10.1007/s00264-021-05042-0. Epub 2021 Apr 22.
PubMed 33885922Sangiorgio SN, Ho NC, Morgan RD, Ebramzadeh E, Zionts LE. The Objective Measurement of Brace-Use Adherence in the Treatment of Idiopathic Clubfoot. J Bone Joint Surg Am. 2016 Oct 5;98(19):1598-1605. doi: 10.2106/JBJS.16.00170.
PubMed 27707845Masrouha KZ, Moses MJ, Sala DA, Litrenta J, Lehman WB, Chu A. The Validity of Patient-reported Outcome Measurement Information System (PROMIS) Parent Proxy Instruments to Assess Function in Children With Talipes Equinovarus. J Pediatr Orthop. 2019 Nov/Dec;39(10):e787-e790. doi: 10.1097/BPO.0000000000001368.
PubMed 30913133Varni JW, Limbers CA, Burwinkle TM. How young can children reliably and validly self-report their health-related quality of life?: an analysis of 8,591 children across age subgroups with the PedsQL 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007 Jan 3;5:1. doi: 10.1186/1477-7525-5-1.
PubMed 17201920Mitchell JR, inventor. Quick clip for a club foot device. United States patent US 20160113803A1. 2002 Jun 9.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Novel Dynamic Bar for Foot Abduction Brace for Clubfoot Treatment
- ClinicalTrials.gov ID
- NCT05293743
- Acronym / sponsor ID
- 1000078967
- Conditions
- Clubfoot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Posted 25 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental arm with new device, control arm with standard device.
| Arm | Type | Receives |
|---|---|---|
| Standard Bar | Active comparator | Device: Foot abduction bracing for clubfoot with Standard BarThis group will continue using the Standard Bar as part of their brace, per their current treatment. |
| Dynamic Bar | Experimental | Device: Foot abduction bracing for clubfoot with novel Dynamic BarThis group will use the Dynamic Bar for 30 days instead of their Standard Bar. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot abduction bracing for clubfoot with novel Dynamic BarAfter 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. | Device | Dynamic Bar |
| Foot abduction bracing for clubfoot with Standard BarAfter 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. | Device | Standard Bar |
Primary outcome
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.
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.
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.
8 secondary outcomes
Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar
Time frame: 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).
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.
Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses
Time frame: 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.
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
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
Number of Clubfoot Recurrences During the Study Period
Time frame: Study period lasted approximately 90 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19823650Anand A, Sala DA. Clubfoot: etiology and treatment. Indian J Orthop. 2008 Jan;42(1):22-8. doi: 10.4103/0019-5413.38576.
- Background: PubMed 31312265Alves C. Bracing in clubfoot: do we know enough? J Child Orthop. 2019 Jun 1;13(3):258-264. doi: 10.1302/1863-2548.13.190069.
- BackgroundHospital for Special Surgery [Internet]. New York: HSS. Method for Correcting Clubfoot: Overview for Parent; 2019 Sept 12 [cited 2021 Jan 11] Available from: https://www.hss.edu/conditions_thse-ponseti-method-for-clubfoot-correction.asp.
- Background: PubMed 19495824Garg S, Porter K. Improved bracing compliance in children with clubfeet using a dynamic orthosis. J Child Orthop. 2009 Aug;3(4):271-6. doi: 10.1007/s11832-009-0182-9. Epub 2009 Jun 3.
- BackgroundSickKids Internal Document. CLUBFOOT FAO BAR OPTIONS June 2017 edited. 2017 June.
- Background: PubMed 27803913Azarpira MR, Emami MJ, Vosoughi AR, Rahbari K. Factors associated with recurrence of clubfoot treated by the Ponseti method. World J Clin Cases. 2016 Oct 16;4(10):318-322. doi: 10.12998/wjcc.v4.i10.318.
- Background: PubMed 25177447Zhao D, Liu J, Zhao L, Wu Z. Relapse of clubfoot after treatment with the Ponseti method and the function of the foot abduction orthosis. Clin Orthop Surg. 2014 Sep;6(3):245-52. doi: 10.4055/cios.2014.6.3.245. Epub 2014 Aug 5.
- BackgroundAmerican Academy of Orthopaedic Surgeons [Internet]. Illinois: AAOS. Study Finds Ponseti Method Remains an Effective Treatment for Clubfoot, Bracing Is Paramount; 2021 Jan 18 [cited 2021 May 25] Available from: https://www.aaos.org/aaosnow/2020/aaos-now-special-edition/research/662_pediatrics.
- Background: PubMed 31154846Gelfer Y, Wientroub S, Hughes K, Fontalis A, Eastwood DM. Congenital talipes equinovarus: a systematic review of relapse as a primary outcome of the Ponseti method. Bone Joint J. 2019 Jun;101-B(6):639-645. doi: 10.1302/0301-620X.101B6.BJJ-2018-1421.R1.
- Background: PubMed 24787312Morgenstein A, Davis R, Talwalkar V, Iwinski H Jr, Walker J, Milbrandt TA. A randomized clinical trial comparing reported and measured wear rates in clubfoot bracing using a novel pressure sensor. J Pediatr Orthop. 2015 Mar;35(2):185-91. doi: 10.1097/BPO.0000000000000205.
- Background: PubMed 33885922Aroojis A, Pandey T, Dusa A, Krishnan AG, Ghyar R, Ravi B. Development of a functional prototype of a SMART (Sensor-integrated for Monitoring And Remote Tracking) foot abduction brace for clubfoot treatment: a pre-clinical evaluation. Int Orthop. 2021 Sep;45(9):2401-2410. doi: 10.1007/s00264-021-05042-0. Epub 2021 Apr 22.
- Background: PubMed 27707845Sangiorgio SN, Ho NC, Morgan RD, Ebramzadeh E, Zionts LE. The Objective Measurement of Brace-Use Adherence in the Treatment of Idiopathic Clubfoot. J Bone Joint Surg Am. 2016 Oct 5;98(19):1598-1605. doi: 10.2106/JBJS.16.00170.
- Individual participant dataSharing planned: No. We do not plan on sharing this data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryse Bouchard, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot abduction bracing for clubfoot with novel Dynamic Bar and Foot abduction bracing for clubfoot with Standard Bar in people with Clubfoot, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment of Patients for a Prospective Trial Comparing Clubfoot Brace Types (time frame: Recruitment period lasted approximately 8 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05293743, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.