Outcomes of Compliance With Brace Wear in Clubfoot
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic, Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any - 3 |
| Updated: | 2/7/2015 |
| Start Date: | October 2009 |
| Contact: | Rebecca Davis |
| Email: | rfdavis@shrinenet.org |
| Phone: | 859-268-5705 |
Measurement of Compliance in Clubfoot Bracing Via a Novel Pressure Sensor
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 FAO wear is less than self-reported compliance and
noncompliance is correlated to future surgeries.
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 FAO wear is less than self-reported compliance and
noncompliance is correlated to future surgeries.
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.
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.
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
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