Clubfoot
Conditions
Brief summary
The goal of this clinical trial is to evaluate a new Dynamic Bar for foot abduction bracing for clubfoot treatment. The main questions that this study aims to answer are: * How easy is it to recruit and retain participants for a randomized-controlled effectiveness trial of a novel foot abduction bar? * How does parental perception of child comfort in the Dynamic Bar compare to parental perception of child comfort in standard bars? * How does patient tolerance of the Dynamic Bar compare patient tolerance of standard bars? * How effective is the Dynamic Bar at preventing clubfoot recurrence during the bracing phase when the brace is worn as prescribed for a 30-day trial period? Each participant will be randomized into one of two arms: the experimental arm or the control arm. For the first 30 days, the experimental arm will wear the new Dynamic Bar with standard boots and the control arm will continue wearing their standard bar. After this 30-day period, the experimental arm will return to wearing their standard bar.
Detailed description
This is an assessor-blinded randomized feasibility trial assessing the feasibility of conducting a large-scale clinical trial to evaluate the effectiveness of a new dynamic bar for foot abduction bracing for clubfoot treatment. Feasibility will be determined by the ability to recruit patients within the goal study period and to retain participants. Eligible patients must have a well-corrected idiopathic clubfoot (Pirani Score ≤ 0.5) and be in the minimum 12 hours per day bracing stage of the Ponseti clubfoot treatment protocol. The overall study period will be 90 days in length. For the first 30 days, the experimental cohort will wear the new Dynamic Bar (DB) with standard ankle-foot orthoses (boots) and the control cohort will continue wearing their Standard Bar (SB). After this 30-day period, the experimental cohort will return to wearing their SB. All patients will be evaluated on Day 0, Day 7, Day 30, and Day 90 of the study period to monitor for recurrence of the clubfoot deformity, complications of brace wearing, to submit brace wear logs, and to complete parent-reported questionnaires regarding their perceptions of the Foot Abduction Brace (FAB) and their child's comfort. A minimum of 10 patients per arm will be recruited. A temperature sensor will be added in each participant's boots during the 90-day study period to objectively measure time of brace wear. It is hypothesized that when patients are wearing the DB, they will experience higher brace tolerance defined as increased wear time of the brace as measured by the temperature sensors, and higher comfort levels as reported by parents, without an increase in clubfoot deformity recurrence compared to the SB. Most patient information that will be reviewed in this study is data being collected and stored per the REB-approved Clubfoot Research Registry protocol (REB #1000053919). All patients enrolled in study this will also be enrolled in Clubfoot Research Registry, if not already enrolled. The novel DB is designed by the research team and allows independent movement of the knees and hips while maintaining a corrective position of the foot.
Interventions
DEVICEFoot 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.
DEVICEFoot 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.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Outcomes Assessor)
Masking description
The clinician assessing foot shape for recurrence will be blinded to the brace type. Clinicians involved in fitting the brace will not be.
Intervention model description
Experimental arm with new device, control arm with standard device.
Eligibility
Sex/Gender
ALL
Age
1 Years to 3 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | 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. |
| Recruitment of Patients for a Prospective Trial Comparing Clubfoot Brace Types | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental Perception of Child Comfort - If Child Had a Hard Time Returning to the Standard Bar After Wearing the Dynamic Bar | 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. |
| Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses | 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. |
| Patient Tolerance of Bracing - Experimental Arm vs. Control Arm - Overall Average | 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 |
| Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - N of 1 | 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. |
| Number of Clubfoot Recurrences During the Study Period | 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). |
| Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - Overall Average | 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. |
| Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar | 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. |
| Parental Perception of Child Comfort - Preferred 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). | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Video Data Analysis - Comparing the Range of Motion Provided by the Dynamic Bar vs. Standard Bar | 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. |
Countries
Canada
Participant flow
Recruitment details
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.
Pre-assignment details
Out of the 17 participants who consented to participate, 5 withdrew before beginning their participation in the study. The remaining 12 participants were randomized to treatment, however 1 control participant withdrew after their first study visit.
Participants by arm
| Arm | Count |
|---|---|
| Control Arm This group continued using the Standard Bar as part of their brace, per their current treatment. | 4 |
| Experimental Arm This group used the Dynamic Bar for 30 days instead of their Standard Bar. | 7 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Control Arm | Experimental Arm | Total |
|---|---|---|---|
| Age, Continuous | 24.9 months | 27.6 months | 26.6 months |
| Diagnosis Bilateral idiopathic clubfoot | 1 Participants | 2 Participants | 3 Participants |
| Diagnosis Unilateral idiopathic clubfoot | 3 Participants | 5 Participants | 8 Participants |
| Height | 87.7 cm | 89.9 cm | 89.1 cm |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
| Weight | 13.5 kg | 13.9 kg | 13.8 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 7 |
| other Total, other adverse events | 3 / 4 | 4 / 7 |
| serious Total, serious adverse events | 0 / 4 | 0 / 7 |
Outcome results
Primary
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.
Population: 4 patients completed participation in the control arm, and 7 patients completed participation in the experimental arm.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Expected Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | First day: Parents asked if they had concerns about participating in the study. | Agree | 0 Participants |
| Expected Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | Last day: Parents asked if they would be interested in participating in a future study. | Unsure | 0 Participants |
| Expected Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | First day: Parents asked if they had concerns about participating in the study. | Strongly Agree | 0 Participants |
| Expected Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | First day: Parents asked if they had concerns about participating in the study. | Disagree | 3 Participants |
| Expected Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | Last day: Parents asked if they would be interested in participating in a future study. | Strongly Disagree | 0 Participants |
| Expected Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | Last day: Parents asked if they would be interested in participating in a future study. | Strongly Agree | 2 Participants |
| Expected Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | Last day: Parents asked if they would be interested in participating in a future study. | Disagree | 0 Participants |
| Expected Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | First day: Parents asked if they had concerns about participating in the study. | Unsure | 0 Participants |
| Expected Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | Last day: Parents asked if they would be interested in participating in a future study. | Agree | 2 Participants |
| Expected Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | First day: Parents asked if they had concerns about participating in the study. | Strongly Disagree | 1 Participants |
| Actual Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | Last day: Parents asked if they would be interested in participating in a future study. | Strongly Agree | 5 Participants |
| Actual Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | Last day: Parents asked if they would be interested in participating in a future study. | Agree | 1 Participants |
| Actual Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | First day: Parents asked if they had concerns about participating in the study. | Strongly Disagree | 3 Participants |
| Actual Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | First day: Parents asked if they had concerns about participating in the study. | Disagree | 4 Participants |
| Actual Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | First day: Parents asked if they had concerns about participating in the study. | Unsure | 0 Participants |
| Actual Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | First day: Parents asked if they had concerns about participating in the study. | Agree | 0 Participants |
| Actual Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | First day: Parents asked if they had concerns about participating in the study. | Strongly Agree | 0 Participants |
| Actual Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | Last day: Parents asked if they would be interested in participating in a future study. | Strongly Disagree | 0 Participants |
| Actual Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | Last day: Parents asked if they would be interested in participating in a future study. | Unsure | 1 Participants |
| Actual Number of Patients Recruited | Parent Satisfaction in a Prospective Trial Comparing Clubfoot Brace Types | Last day: Parents asked if they would be interested in participating in a future study. | Disagree | 0 Participants |
Primary
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.
Population: 79 patients were deemed eligible to participate and approached for consent during the recruitment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expected Number of Patients Recruited | Recruitment of Patients for a Prospective Trial Comparing Clubfoot Brace Types | 59 Participants |
| Actual Number of Patients Recruited | Recruitment of Patients for a Prospective Trial Comparing Clubfoot Brace Types | 17 Participants |
Primary
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.
Population: 17 patients initially consented to participate in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expected Number of Patients Recruited | Retention of Patients for a Prospective Trial Comparing Clubfoot Brace Types | 0 Participants |
| Actual Number of Patients Recruited | Retention of Patients for a Prospective Trial Comparing Clubfoot Brace Types | 6 Participants |
Secondary
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.
Population: All parents self-reported fair compliance to the prescribed bracing schedule (within 1 hour of the prescribed bracing range per day). However, the sensors reported that 3 patients wore the brace much less than prescribed during the study (deficit of \>1.5 hours/day).~Note that all AEs related to recurrence were classified as non-serious, mild, and not unexpected, and therefore may not represent a true relapse in clubfoot treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Expected Number of Patients Recruited | Number of Clubfoot Recurrences During the Study Period | All patients | 2 Participants |
| Expected Number of Patients Recruited | Number of Clubfoot Recurrences During the Study Period | Patients with fair brace compliance per logs and sensors (+/- 1 hr of the prescribed range per day) | 1 Participants |
| Actual Number of Patients Recruited | Number of Clubfoot Recurrences During the Study Period | All patients | 0 Participants |
| Actual Number of Patients Recruited | Number of Clubfoot Recurrences During the Study Period | Patients with fair brace compliance per logs and sensors (+/- 1 hr of the prescribed range per day) | 0 Participants |
Secondary
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.
Population: 7 participants were randomized to the experimental arm to try out the Dynamic Bar.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses | Ability to move feet/legs normally in bar | 3.4 score on a scale |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses | Parent satisfaction with shape of bar | 3.9 score on a scale |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses | Child comfort in bar | 4.3 score on a scale |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses | Parent satisfaction with size of bar | 3.9 score on a scale |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses | Parent satisfaction with weight of bar | 4.0 score on a scale |
| Actual Number of Patients Recruited | Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses | Parent satisfaction with size of bar | 4.6 score on a scale |
| Actual Number of Patients Recruited | Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses | Ability to move feet/legs normally in bar | 4.4 score on a scale |
| Actual Number of Patients Recruited | Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses | Parent satisfaction with weight of bar | 3.9 score on a scale |
| Actual Number of Patients Recruited | Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses | Parent satisfaction with shape of bar | 4.3 score on a scale |
| Actual Number of Patients Recruited | Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses | Child comfort in bar | 4.6 score on a scale |
Secondary
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.
Population: 7 participants were randomized to the experimental arm to try out the Dynamic Bar.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar | Much less comfortable | 0 Participants |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar | Less comfortable | 0 Participants |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar | Equally comfortable | 0 Participants |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar | More comfortable | 4 Participants |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar | Much more comfortable | 3 Participants |
Secondary
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.
Population: 7 participants were randomized to the experimental arm to try out the Dynamic Bar.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - If Child Had a Hard Time Returning to the Standard Bar After Wearing the Dynamic Bar | Strongly Agree | 0 Participants |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - If Child Had a Hard Time Returning to the Standard Bar After Wearing the Dynamic Bar | Strongly Disagree | 2 Participants |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - If Child Had a Hard Time Returning to the Standard Bar After Wearing the Dynamic Bar | Disagree | 2 Participants |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - If Child Had a Hard Time Returning to the Standard Bar After Wearing the Dynamic Bar | Unsure | 1 Participants |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - If Child Had a Hard Time Returning to the Standard Bar After Wearing the Dynamic Bar | Agree | 2 Participants |
Secondary
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).
Population: 7 participants were randomized to the experimental arm to try out the Dynamic Bar.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - Preferred Bar | Parent asked to indicate their preferred bar at the end of the study's intervention period. | Standard Bar | 0 Participants |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - Preferred Bar | Parent asked to indicate their preferred bar at the end of the study's intervention period. | Unsure | 2 Participants |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - Preferred Bar | Parent asked to indicate their preferred bar at the end of the study's intervention period. | Dynamic Bar | 5 Participants |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - Preferred Bar | Parent asked to indicate their preferred bar at the end of the study's intervention period. | Other | 0 Participants |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - Preferred Bar | Parent asked to indicate their preferred bar on the last day of the study. | Standard Bar | 0 Participants |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - Preferred Bar | Parent asked to indicate their preferred bar on the last day of the study. | Unsure | 1 Participants |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - Preferred Bar | Parent asked to indicate their preferred bar on the last day of the study. | Dynamic Bar | 6 Participants |
| Expected Number of Patients Recruited | Parental Perception of Child Comfort - Preferred Bar | Parent asked to indicate their preferred bar on the last day of the study. | Other | 0 Participants |
Secondary
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
Population: 7 patients completed participation in the experimental arm. Note that 2 of these parents lost their brace wear logs when their child was wearing the Standard Bar, and 1 of these parents lost their brace wear log when their child was wearing the Dynamic Bar. As such, only 5/7 had brace log data in both bar types that could be used in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Expected Number of Patients Recruited | Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - N of 1 | Parent-reported brace logs | 2 Participants |
| Expected Number of Patients Recruited | Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - N of 1 | iButton temperature sensors | 2 Participants |
| Actual Number of Patients Recruited | Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - N of 1 | Parent-reported brace logs | 3 Participants |
| Actual Number of Patients Recruited | Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - N of 1 | iButton temperature sensors | 5 Participants |
Secondary
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
Population: 7 patients completed participation in the experimental arm. Note that 2 of these parents lost their brace wear logs when their child was wearing the Standard Bar, and 1 of these parents lost their brace wear log when their child was wearing the Dynamic Bar.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Expected Number of Patients Recruited | Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - Overall Average | Parent-reported brace logs | 0.96 Average Adherence Fraction | Standard Deviation 0.09 |
| Expected Number of Patients Recruited | Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - Overall Average | iButton temperature sensors | 0.78 Average Adherence Fraction | Standard Deviation 0.24 |
| Actual Number of Patients Recruited | Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - Overall Average | Parent-reported brace logs | 0.97 Average Adherence Fraction | Standard Deviation 0.06 |
| Actual Number of Patients Recruited | Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - Overall Average | iButton temperature sensors | 0.91 Average Adherence Fraction | Standard Deviation 0.07 |
Comparison: The null hypothesis is that there is no difference in brace adherence fractions when the experimental arm is wearing the Dynamic Bar versus the Standard Bar during the study period. In this test, brace wear was measured by parent-reported brace logs.p-value: 0.86t-test, 2 sided
Comparison: The null hypothesis is that there is no difference in brace adherence fractions when the experimental arm is wearing the Dynamic Bar versus the Standard Bar during the study period. In this test, brace wear was measured by iButton temperature sensors.p-value: 0.21t-test, 2 sided
Secondary
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.
Population: 4 patients completed participation in the control arm, and 7 patients completed participation in the experimental arm. Note that 1 parent in the experimental arm lost their brace wear log during the study's intervention period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Expected Number of Patients Recruited | Patient Tolerance of Bracing - Experimental Arm vs. Control Arm - Overall Average | Parent-reported brace logs | 1.01 Average Adherence Fraction | Standard Deviation 0.14 |
| Expected Number of Patients Recruited | Patient Tolerance of Bracing - Experimental Arm vs. Control Arm - Overall Average | iButton temperature sensors | 1.03 Average Adherence Fraction | Standard Deviation 0.15 |
| Actual Number of Patients Recruited | Patient Tolerance of Bracing - Experimental Arm vs. Control Arm - Overall Average | Parent-reported brace logs | 0.97 Average Adherence Fraction | Standard Deviation 0.06 |
| Actual Number of Patients Recruited | Patient Tolerance of Bracing - Experimental Arm vs. Control Arm - Overall Average | iButton temperature sensors | 0.91 Average Adherence Fraction | Standard Deviation 0.07 |
Comparison: The null hypothesis is that there is no difference in brace adherence fractions between the control arm and the experimental arm during the study's intervention period. In this test, brace wear was measured by parent-reported brace logs.p-value: 0.67t-test, 2 sided
Comparison: The null hypothesis is that there is no difference in brace adherence fractions between the control arm and the experimental arm during the study's intervention period. In this test, brace wear was measured by iButton temperature sensors.p-value: 0.23t-test, 2 sided
Post Hoc
Breakages and Malfunctions of the Dynamic Bar Prototype
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.
Time frame: Each patient in the experimental arm used the Dynamic Bar for approximately 30 days. Most Dynamic Bars were only used by one patient, but two Dynamic Bars were used by two patients each.
Population: The first two breakages/malfunctions identified below resulted in the immediate suspension of the Dynamic Bar prototypes until the bars could be redesigned.~The last three breakages/malfunctions identified below are specific to the latest version of the Dynamic Bar, which was used on all 7 participants in the experimental arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Expected Number of Patients Recruited | Breakages and Malfunctions of the Dynamic Bar Prototype | Crossbar snapped in two | 1 cases observed |
| Expected Number of Patients Recruited | Breakages and Malfunctions of the Dynamic Bar Prototype | Participant pinched their finger in the pin-slot mechanism (this prompted immediate bar redesign) | 1 cases observed |
| Expected Number of Patients Recruited | Breakages and Malfunctions of the Dynamic Bar Prototype | Ball joint popped out of socket in ball joint linkage (this prompted immediate bar redesign) | 3 cases observed |
| Expected Number of Patients Recruited | Breakages and Malfunctions of the Dynamic Bar Prototype | End caps on the L brackets were torn by the participant | 2 cases observed |
| Expected Number of Patients Recruited | Breakages and Malfunctions of the Dynamic Bar Prototype | Wear was observed on the brass components in the ball joint linkages | 6 cases observed |
Other Pre-specified
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.
Population: All participants consented to video recording.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Expected Number of Patients Recruited | Video Data Analysis - Comparing the Range of Motion Provided by the Dynamic Bar vs. Standard Bar | Patients that were noted to achieve normal developmental motor skills during video recording. | 4 Participants |
| Expected Number of Patients Recruited | Video Data Analysis - Comparing the Range of Motion Provided by the Dynamic Bar vs. Standard Bar | Patients that were noted to achieve intermittent ankle plantarflexion during video recording. | 1 Participants |
| Actual Number of Patients Recruited | Video Data Analysis - Comparing the Range of Motion Provided by the Dynamic Bar vs. Standard Bar | Patients that were noted to achieve normal developmental motor skills during video recording. | 7 Participants |
| Actual Number of Patients Recruited | Video Data Analysis - Comparing the Range of Motion Provided by the Dynamic Bar vs. Standard Bar | Patients that were noted to achieve intermittent ankle plantarflexion during video recording. | 2 Participants |