Effect of foot abduction brace type on brace-wear compliance in idiopathic clubfoot
Grant Recipient: Elizabeth Hubbard
- Institution:
- Shriners Hospital, Lexington, KY
- Additional Information:
- Title of Project: Effect of foot abduction brace type on brace-wear compliance in idiopathic clubfoot
Principle Investigator: Elizabeth W. Hubbard, MD
Co-Investigators: Ryan Muchow MD, Janet L. Walker MD, Vishwas J. Talwalkar MD, Henry Iwinski MD
Oirginal Study Summary:
Forty patients with congenital talipes equinovarus will be prospectively enrolled at the time of cast initiation. Patients will be randomized to receive either a rigid (rFAO) or dynamic foot abduction orthosis (dAFO), with 20 patients per group. Each orthosis will be fit with a temperature sensor to monitor brace-wear. After 3 months of continuous brace-wear, patients will be transitioned to “night and naptime” wear, with a recommended in-brace time of 10 hours per 24-hour period. Patients will be followed for a minimum of 2 years.
The primary outcome will be to compare average daily in-brace hours for patients treated with rFAO versus dFAO for the treatment period as measured by temperature sensor monitors. Secondary outcomes include measuring the rate of recurrence in each group, requiring either repeat casting or surgical intervention after initiation of bracing.
Project Update:
Over the past year, we enrolled 18 patients. Two patients were subsequently withdrawn from the study (one patient was diagnosed with a neuromuscular syndrome; one patient did not have appropriate pre-treatment scoring of the severity of the clubfoot position). The remaining 16 patients have been randomized and are currently undergoing brace treatment. All patients are still being actively treated with foot abduction orthoses. The $1000 grant money has been used to purchase 50 temperature sensors (see financial update below).
The primary outcome cannot be determined at this time because we are still enrolling participants. We are continuing to enroll patients and our goal is to follow the cohort for a minimum of 2 years. Patients and families are tolerating the brace treatment well. At this time, the main issue with the study is patient enrollment. Eligible patients are being appropriately captured and approached by the treatment team but parental willingness to enroll their child has limited study numbers to date.
Our goal is to complete study enrollment with a goal total of 40 patients. Patients will be followed for 2 years after initiated of brace treatment. Our publication goals are as follows:
- Short-term follow-up results analyzing compliance rates between patient groups after all study patients complete the initial 3-month continuous brace wear treatment
- 2-year follow-up analyzing compliance rates between patient groups after all study patients complete 2-year follow-up for brace treatment
Expense Report:
Total Grant Amount: $1,000
Purchase:
Temperature sensor monitor $70/unit; purchased 50 units
Total expenditure: $3,500
Grant Remaining: -$2,500
**The additional cost ($2,500) was covered by a secondary grant by Kosair Charities.
