Trial Outcomes & Findings for Novel Dynamic Foot Abduction Bar for Treatment of Clubfoot (NCT NCT05293743)
NCT ID: NCT05293743
Last Updated: 2025-05-22
Results Overview
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.
COMPLETED
NA
17 participants
Recruitment period lasted approximately 8 months.
2025-05-22
Participant Flow
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.
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.
Participant milestones
| Measure |
Control Arm
This group continued using the Standard Bar as part of their brace, per their current treatment.
|
Experimental Arm
This group used the Dynamic Bar for 30 days instead of their Standard Bar.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
|
Overall Study
COMPLETED
|
4
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Control Arm
This group continued using the Standard Bar as part of their brace, per their current treatment.
|
Experimental Arm
This group used the Dynamic Bar for 30 days instead of their Standard Bar.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Arm
n=4 Participants
This group continued using the Standard Bar as part of their brace, per their current treatment.
|
Experimental Arm
n=7 Participants
This group used the Dynamic Bar for 30 days instead of their Standard Bar.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.9 months
n=4 Participants
|
27.6 months
n=7 Participants
|
26.6 months
n=11 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=4 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=11 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Diagnosis
Unilateral idiopathic clubfoot
|
3 Participants
n=4 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=11 Participants
|
|
Diagnosis
Bilateral idiopathic clubfoot
|
1 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=11 Participants
|
|
Height
|
87.7 cm
n=4 Participants
|
89.9 cm
n=7 Participants
|
89.1 cm
n=11 Participants
|
|
Weight
|
13.5 kg
n=4 Participants
|
13.9 kg
n=7 Participants
|
13.8 kg
n=11 Participants
|
PRIMARY outcome
Timeframe: Recruitment period lasted approximately 8 months.Population: 79 patients were deemed eligible to participate and approached for consent during the recruitment period.
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.
Outcome measures
| Measure |
Expected Number of Patients Recruited
n=79 Participants
Number of eligible patients who were expected to consent to participate.
|
Actual Number of Patients Recruited
n=79 Participants
Number of eligible patients who did consent to participate.
|
|---|---|---|
|
Recruitment of Patients for a Prospective Trial Comparing Clubfoot Brace Types
|
59 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Study period lasted approximately 90 days.Population: 17 patients initially consented to participate in the study.
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.
Outcome measures
| Measure |
Expected Number of Patients Recruited
n=17 Participants
Number of eligible patients who were expected to consent to participate.
|
Actual Number of Patients Recruited
n=17 Participants
Number of eligible patients who did consent to participate.
|
|---|---|---|
|
Retention of Patients for a Prospective Trial Comparing Clubfoot Brace Types
|
0 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Study period lasted approximately 90 days.Population: 4 patients completed participation in the control arm, and 7 patients completed participation in the experimental arm.
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.
Outcome measures
| Measure |
Expected Number of Patients Recruited
n=4 Participants
Number of eligible patients who were expected to consent to participate.
|
Actual Number of Patients Recruited
n=7 Participants
Number of eligible patients who did consent to participate.
|
|---|---|---|
|
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
|
3 Participants
|
|
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
|
4 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
1 Participants
|
|
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
|
1 Participants
|
|
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
|
5 Participants
|
SECONDARY outcome
Timeframe: Study period lasted approximately 90 days.Population: 7 participants were randomized to the experimental arm to try out the Dynamic 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.
Outcome measures
| Measure |
Expected Number of Patients Recruited
n=7 Participants
Number of eligible patients who were expected to consent to participate.
|
Actual Number of Patients Recruited
Number of eligible patients who did consent to participate.
|
|---|---|---|
|
Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar
Much less comfortable
|
0 Participants
|
—
|
|
Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar
Less comfortable
|
0 Participants
|
—
|
|
Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar
Equally comfortable
|
0 Participants
|
—
|
|
Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar
More comfortable
|
4 Participants
|
—
|
|
Parental Perception of Child Comfort - How the Dynamic Bar Compares to the Standard Bar
Much more comfortable
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Expected Number of Patients Recruited
n=7 Participants
Number of eligible patients who were expected to consent to participate.
|
Actual Number of Patients Recruited
Number of eligible patients who did consent to participate.
|
|---|---|---|
|
Parental Perception of Child Comfort - Preferred Bar
Parent asked to indicate their preferred bar on the last day of the study. · Unsure
|
1 Participants
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: Study period lasted approximately 90 days.Population: 7 participants were randomized to the experimental arm to try out 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.
Outcome measures
| Measure |
Expected Number of Patients Recruited
n=7 Participants
Number of eligible patients who were expected to consent to participate.
|
Actual Number of Patients Recruited
Number of eligible patients who did consent to participate.
|
|---|---|---|
|
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
|
—
|
|
Parental Perception of Child Comfort - If Child Had a Hard Time Returning to the Standard Bar After Wearing the Dynamic Bar
Disagree
|
2 Participants
|
—
|
|
Parental Perception of Child Comfort - If Child Had a Hard Time Returning to the Standard Bar After Wearing the Dynamic Bar
Unsure
|
1 Participants
|
—
|
|
Parental Perception of Child Comfort - If Child Had a Hard Time Returning to the Standard Bar After Wearing the Dynamic Bar
Agree
|
2 Participants
|
—
|
|
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
|
—
|
SECONDARY outcome
Timeframe: Intervention period lasted approximately 30 days.Population: 7 participants were randomized to the experimental arm to try out the Dynamic Bar.
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.
Outcome measures
| Measure |
Expected Number of Patients Recruited
n=7 Participants
Number of eligible patients who were expected to consent to participate.
|
Actual Number of Patients Recruited
n=7 Participants
Number of eligible patients who did consent to participate.
|
|---|---|---|
|
Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses
Child comfort in bar
|
4.3 score on a scale
Interval 3.0 to 5.0
|
4.6 score on a scale
Interval 4.0 to 5.0
|
|
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
Interval 1.0 to 5.0
|
4.4 score on a scale
Interval 3.0 to 5.0
|
|
Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses
Parent satisfaction with weight of bar
|
4.0 score on a scale
Interval 3.0 to 5.0
|
3.9 score on a scale
Interval 2.0 to 5.0
|
|
Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses
Parent satisfaction with shape of bar
|
3.9 score on a scale
Interval 3.0 to 5.0
|
4.3 score on a scale
Interval 3.0 to 5.0
|
|
Parental Perception of Child Comfort - Comparison of 5-point Likert Scale Responses
Parent satisfaction with size of bar
|
3.9 score on a scale
Interval 2.0 to 5.0
|
4.6 score on a scale
Interval 4.0 to 5.0
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Expected Number of Patients Recruited
n=4 Participants
Number of eligible patients who were expected to consent to participate.
|
Actual Number of Patients Recruited
n=7 Participants
Number of eligible patients who did consent to participate.
|
|---|---|---|
|
Patient Tolerance of Bracing - Experimental Arm vs. Control Arm - Overall Average
Parent-reported brace logs
|
1.01 Average Adherence Fraction
Standard Deviation 0.14
|
0.97 Average Adherence Fraction
Standard Deviation 0.06
|
|
Patient Tolerance of Bracing - Experimental Arm vs. Control Arm - Overall Average
iButton temperature sensors
|
1.03 Average Adherence Fraction
Standard Deviation 0.15
|
0.91 Average Adherence Fraction
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Experimental arm used the Dynamic Bar for approximately 30 days, then used the Standard Bar for approximately 60 daysPopulation: 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.
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.
Outcome measures
| Measure |
Expected Number of Patients Recruited
n=7 Participants
Number of eligible patients who were expected to consent to participate.
|
Actual Number of Patients Recruited
n=7 Participants
Number of eligible patients who did consent to participate.
|
|---|---|---|
|
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
|
0.91 Average Adherence Fraction
Standard Deviation 0.07
|
|
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
|
0.97 Average Adherence Fraction
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Experimental arm used the Dynamic Bar for approximately 30 days, then used the Standard Bar for approximately 60 daysPopulation: 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.
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.
Outcome measures
| Measure |
Expected Number of Patients Recruited
n=7 Participants
Number of eligible patients who were expected to consent to participate.
|
Actual Number of Patients Recruited
n=7 Participants
Number of eligible patients who did consent to participate.
|
|---|---|---|
|
Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - N of 1
Parent-reported brace logs
|
2 Participants
|
3 Participants
|
|
Patient Tolerance of Bracing - Dynamic Bar vs. Standard Bar (Experimental Arm Only) - N of 1
iButton temperature sensors
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Expected Number of Patients Recruited
n=4 Participants
Number of eligible patients who were expected to consent to participate.
|
Actual Number of Patients Recruited
n=7 Participants
Number of eligible patients who did consent to participate.
|
|---|---|---|
|
Number of Clubfoot Recurrences During the Study Period
All patients
|
2 Participants
|
0 Participants
|
|
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
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Each video recording was approximately 2 minutes in length.Population: All participants consented to video recording.
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.
Outcome measures
| Measure |
Expected Number of Patients Recruited
n=4 Participants
Number of eligible patients who were expected to consent to participate.
|
Actual Number of Patients Recruited
n=7 Participants
Number of eligible patients who did consent to participate.
|
|---|---|---|
|
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
|
7 Participants
|
|
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
|
2 Participants
|
POST_HOC outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Expected Number of Patients Recruited
n=7 Participants
Number of eligible patients who were expected to consent to participate.
|
Actual Number of Patients Recruited
Number of eligible patients who did consent to participate.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
Breakages and Malfunctions of the Dynamic Bar Prototype
End caps on the L brackets were torn by the participant
|
2 cases observed
|
—
|
|
Breakages and Malfunctions of the Dynamic Bar Prototype
Crossbar snapped in two
|
1 cases observed
|
—
|
|
Breakages and Malfunctions of the Dynamic Bar Prototype
Wear was observed on the brass components in the ball joint linkages
|
6 cases observed
|
—
|
Adverse Events
Control Arm Using Standard Bar
Experimental Arm Using Experimental Bar Then Standard Bar
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Arm Using Standard Bar
n=4 participants at risk
This group continued using the Standard Bar as part of their brace, per their current treatment.
|
Experimental Arm Using Experimental Bar Then Standard Bar
n=7 participants at risk
This group used the Dynamic Bar for 30 days then returned to their Standard Bar for 60 days.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pressure sore, skin rash, and/or redness
|
50.0%
2/4 • Number of events 2 • Adverse Event (AE) data was collected at each study visit over the entire study period, which lasted for approximately 3 months per participant.
AEs were classified as: Serious or non-serious; Mild, moderate, or severe; Unexpected or not unexpected; Unrelated, unlikely to be related, possibly related, probably related, or definitely related to the bar. It is not appropriate to separate the 'Experimental Arm wearing the Dynamic Bar' from the 'Experimental Arm wearing the Standing Bar' because the study period is short and there is potential for late-onset AEs. (AEs may have been caused by the Dynamic Bar but were only noted on Day 90.)
|
42.9%
3/7 • Number of events 4 • Adverse Event (AE) data was collected at each study visit over the entire study period, which lasted for approximately 3 months per participant.
AEs were classified as: Serious or non-serious; Mild, moderate, or severe; Unexpected or not unexpected; Unrelated, unlikely to be related, possibly related, probably related, or definitely related to the bar. It is not appropriate to separate the 'Experimental Arm wearing the Dynamic Bar' from the 'Experimental Arm wearing the Standing Bar' because the study period is short and there is potential for late-onset AEs. (AEs may have been caused by the Dynamic Bar but were only noted on Day 90.)
|
|
Product Issues
Pinched finger in foot abduction bar
|
0.00%
0/4 • Adverse Event (AE) data was collected at each study visit over the entire study period, which lasted for approximately 3 months per participant.
AEs were classified as: Serious or non-serious; Mild, moderate, or severe; Unexpected or not unexpected; Unrelated, unlikely to be related, possibly related, probably related, or definitely related to the bar. It is not appropriate to separate the 'Experimental Arm wearing the Dynamic Bar' from the 'Experimental Arm wearing the Standing Bar' because the study period is short and there is potential for late-onset AEs. (AEs may have been caused by the Dynamic Bar but were only noted on Day 90.)
|
14.3%
1/7 • Number of events 1 • Adverse Event (AE) data was collected at each study visit over the entire study period, which lasted for approximately 3 months per participant.
AEs were classified as: Serious or non-serious; Mild, moderate, or severe; Unexpected or not unexpected; Unrelated, unlikely to be related, possibly related, probably related, or definitely related to the bar. It is not appropriate to separate the 'Experimental Arm wearing the Dynamic Bar' from the 'Experimental Arm wearing the Standing Bar' because the study period is short and there is potential for late-onset AEs. (AEs may have been caused by the Dynamic Bar but were only noted on Day 90.)
|
|
Musculoskeletal and connective tissue disorders
Development of mild MTP adduction
|
25.0%
1/4 • Number of events 1 • Adverse Event (AE) data was collected at each study visit over the entire study period, which lasted for approximately 3 months per participant.
AEs were classified as: Serious or non-serious; Mild, moderate, or severe; Unexpected or not unexpected; Unrelated, unlikely to be related, possibly related, probably related, or definitely related to the bar. It is not appropriate to separate the 'Experimental Arm wearing the Dynamic Bar' from the 'Experimental Arm wearing the Standing Bar' because the study period is short and there is potential for late-onset AEs. (AEs may have been caused by the Dynamic Bar but were only noted on Day 90.)
|
14.3%
1/7 • Number of events 1 • Adverse Event (AE) data was collected at each study visit over the entire study period, which lasted for approximately 3 months per participant.
AEs were classified as: Serious or non-serious; Mild, moderate, or severe; Unexpected or not unexpected; Unrelated, unlikely to be related, possibly related, probably related, or definitely related to the bar. It is not appropriate to separate the 'Experimental Arm wearing the Dynamic Bar' from the 'Experimental Arm wearing the Standing Bar' because the study period is short and there is potential for late-onset AEs. (AEs may have been caused by the Dynamic Bar but were only noted on Day 90.)
|
|
Musculoskeletal and connective tissue disorders
Development of mild dynamic supination
|
25.0%
1/4 • Number of events 1 • Adverse Event (AE) data was collected at each study visit over the entire study period, which lasted for approximately 3 months per participant.
AEs were classified as: Serious or non-serious; Mild, moderate, or severe; Unexpected or not unexpected; Unrelated, unlikely to be related, possibly related, probably related, or definitely related to the bar. It is not appropriate to separate the 'Experimental Arm wearing the Dynamic Bar' from the 'Experimental Arm wearing the Standing Bar' because the study period is short and there is potential for late-onset AEs. (AEs may have been caused by the Dynamic Bar but were only noted on Day 90.)
|
0.00%
0/7 • Adverse Event (AE) data was collected at each study visit over the entire study period, which lasted for approximately 3 months per participant.
AEs were classified as: Serious or non-serious; Mild, moderate, or severe; Unexpected or not unexpected; Unrelated, unlikely to be related, possibly related, probably related, or definitely related to the bar. It is not appropriate to separate the 'Experimental Arm wearing the Dynamic Bar' from the 'Experimental Arm wearing the Standing Bar' because the study period is short and there is potential for late-onset AEs. (AEs may have been caused by the Dynamic Bar but were only noted on Day 90.)
|
|
Musculoskeletal and connective tissue disorders
Decreased eversion strength
|
25.0%
1/4 • Number of events 1 • Adverse Event (AE) data was collected at each study visit over the entire study period, which lasted for approximately 3 months per participant.
AEs were classified as: Serious or non-serious; Mild, moderate, or severe; Unexpected or not unexpected; Unrelated, unlikely to be related, possibly related, probably related, or definitely related to the bar. It is not appropriate to separate the 'Experimental Arm wearing the Dynamic Bar' from the 'Experimental Arm wearing the Standing Bar' because the study period is short and there is potential for late-onset AEs. (AEs may have been caused by the Dynamic Bar but were only noted on Day 90.)
|
0.00%
0/7 • Adverse Event (AE) data was collected at each study visit over the entire study period, which lasted for approximately 3 months per participant.
AEs were classified as: Serious or non-serious; Mild, moderate, or severe; Unexpected or not unexpected; Unrelated, unlikely to be related, possibly related, probably related, or definitely related to the bar. It is not appropriate to separate the 'Experimental Arm wearing the Dynamic Bar' from the 'Experimental Arm wearing the Standing Bar' because the study period is short and there is potential for late-onset AEs. (AEs may have been caused by the Dynamic Bar but were only noted on Day 90.)
|
|
Musculoskeletal and connective tissue disorders
Decreased passive dorsiflexion
|
25.0%
1/4 • Number of events 1 • Adverse Event (AE) data was collected at each study visit over the entire study period, which lasted for approximately 3 months per participant.
AEs were classified as: Serious or non-serious; Mild, moderate, or severe; Unexpected or not unexpected; Unrelated, unlikely to be related, possibly related, probably related, or definitely related to the bar. It is not appropriate to separate the 'Experimental Arm wearing the Dynamic Bar' from the 'Experimental Arm wearing the Standing Bar' because the study period is short and there is potential for late-onset AEs. (AEs may have been caused by the Dynamic Bar but were only noted on Day 90.)
|
0.00%
0/7 • Adverse Event (AE) data was collected at each study visit over the entire study period, which lasted for approximately 3 months per participant.
AEs were classified as: Serious or non-serious; Mild, moderate, or severe; Unexpected or not unexpected; Unrelated, unlikely to be related, possibly related, probably related, or definitely related to the bar. It is not appropriate to separate the 'Experimental Arm wearing the Dynamic Bar' from the 'Experimental Arm wearing the Standing Bar' because the study period is short and there is potential for late-onset AEs. (AEs may have been caused by the Dynamic Bar but were only noted on Day 90.)
|
|
Musculoskeletal and connective tissue disorders
Decreased external foot progression angle
|
25.0%
1/4 • Number of events 1 • Adverse Event (AE) data was collected at each study visit over the entire study period, which lasted for approximately 3 months per participant.
AEs were classified as: Serious or non-serious; Mild, moderate, or severe; Unexpected or not unexpected; Unrelated, unlikely to be related, possibly related, probably related, or definitely related to the bar. It is not appropriate to separate the 'Experimental Arm wearing the Dynamic Bar' from the 'Experimental Arm wearing the Standing Bar' because the study period is short and there is potential for late-onset AEs. (AEs may have been caused by the Dynamic Bar but were only noted on Day 90.)
|
0.00%
0/7 • Adverse Event (AE) data was collected at each study visit over the entire study period, which lasted for approximately 3 months per participant.
AEs were classified as: Serious or non-serious; Mild, moderate, or severe; Unexpected or not unexpected; Unrelated, unlikely to be related, possibly related, probably related, or definitely related to the bar. It is not appropriate to separate the 'Experimental Arm wearing the Dynamic Bar' from the 'Experimental Arm wearing the Standing Bar' because the study period is short and there is potential for late-onset AEs. (AEs may have been caused by the Dynamic Bar but were only noted on Day 90.)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place