Clubfoot
Conditions
Keywords
Clubfoot, Compliance, Brace wear
Brief summary
It has been shown that compliance with brace wear can significantly improve the treatment outcome of idiopathic clubfoot deformities. Noncompliance rates have been estimated to be around 30-41% with initial orthosis wear after successful treatment with serial castings. These studies have depended on family logs and not objective data. With the development of a monitoring device, this study hopes to examine: (1) actual patient compliance, (2) comparisons of actual wear time and assumed wear time and (3) the relationship of patient wear with clinical outcomes. Hypothesis: Actual patient compliance in foot abduction orthoses (FAO) wear is less than self-reported compliance and noncompliance is correlated to future surgeries.
Detailed description
It is necessary that treatment teams avoid making any assumptions about patient compliance. This study will objectively measure brace wear-rate in patients with clubfoot that have already been prescribed a foot ankle orthosis. The use of a monitoring device will be able to give objective data on actual patient compliance with brace wear. It is hypothesized that objective compliance data will allow physicians to better assess the patient's therapy progress and outcome, troubleshoot problems or issues associated with barriers to brace wear, and better educate families confronted with having a child with clubfoot. Long term goals will then attempt to determine whether certain brace designs can increase wear time thus decreasing the rate of clubfoot recurrence.
Interventions
None listed
Sponsors
Kosair Charities, Inc.
Shriners Hospitals for Children
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No
Inclusion criteria
* Unilateral or bilateral clubfoot * Birth to 3 years of age * Has been successfully treated with Ponseti casting protocol
Exclusion criteria
* Any other prior treatment for clubfoot * Other existing diagnoses or conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | 3 months | Number of hours per day in brace will be measured by pressure sensor at the end of month 1, month 2 and month 3. Parent report of brace wear will also be documented at each of these timepoints. Wear rate percentage will be calculated by dividing the number of hours of brace wear (either actual as measured by the sensor or reported by parent diary) by the recommended 24 hours. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Functioning Pressure Sensor Group This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning. | 21 |
| Non-Functioning Pressure Sensor Group This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning. | 22 |
| No Sensor Group This group will not have a pressure sensor placed on the foot ankle orthosis. | 20 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Missing Data | 0 | 2 | 2 |
Baseline characteristics
| Characteristic | Functioning Pressure Sensor Group | Non-Functioning Pressure Sensor Group | No Sensor Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 21 Participants | 22 Participants | 20 Participants | 63 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 8 Participants | 19 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 12 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 24 | 0 / 22 |
| serious Total, serious adverse events | 0 / 21 | 0 / 24 | 0 / 22 |
Outcome results
Primary
Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)
Number of hours per day in brace will be measured by pressure sensor at the end of month 1, month 2 and month 3. Parent report of brace wear will also be documented at each of these timepoints. Wear rate percentage will be calculated by dividing the number of hours of brace wear (either actual as measured by the sensor or reported by parent diary) by the recommended 24 hours.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Functioning Pressure Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 1 Actual Wear Rate | 91.7 percentage of time worn |
| Functioning Pressure Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 2 Actual Wear Rate | 86.8 percentage of time worn |
| Functioning Pressure Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 3 Actual Wear Rate | 77.1 percentage of time worn |
| Functioning Pressure Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 1 Reported Wear Rate | 94.9 percentage of time worn |
| Functioning Pressure Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 2 Reported Wear Rate | 95.6 percentage of time worn |
| Functioning Pressure Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 3 Reported Wear Rate | 94.8 percentage of time worn |
| Non-Functioning Pressure Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 3 Reported Wear Rate | 89.4 percentage of time worn |
| Non-Functioning Pressure Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 1 Actual Wear Rate | NA percentage of time worn |
| Non-Functioning Pressure Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 1 Reported Wear Rate | 95.5 percentage of time worn |
| Non-Functioning Pressure Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 2 Reported Wear Rate | 95.8 percentage of time worn |
| Non-Functioning Pressure Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 2 Actual Wear Rate | NA percentage of time worn |
| Non-Functioning Pressure Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 3 Actual Wear Rate | NA percentage of time worn |
| No Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 2 Actual Wear Rate | NA percentage of time worn |
| No Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 3 Actual Wear Rate | NA percentage of time worn |
| No Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 3 Reported Wear Rate | 94.2 percentage of time worn |
| No Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 1 Reported Wear Rate | 94.8 percentage of time worn |
| No Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 1 Actual Wear Rate | NA percentage of time worn |
| No Sensor Group | Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) | Month 2 Reported Wear Rate | 94.9 percentage of time worn |