Study Aims: The primary aims of this study were: (1) To adapt the existing scoliosis BraceRite app for use in clubfoot bracing and to transform our current iButton technology in clubfoot bracing to be bluetooth enabled (2) To establish the BraceRite app as a reliable method to track easily-interpretable objective bracewear measurements for parents and integrate this method into standard of care treatment to improve bracewear adherence in all clubfoot patients (3) To evaluate the outcome of infants who undergo bracing with caregivers using BraceRite app (4) To evaluate if caregiver use of the BraceRite app improves bracewear adherence. The goal was to enroll 70 patients in this study.
Research Findings: The development and testing of the BraceRIte app and the Bluetooth enabled Buttons has been ongoing, and has required extensively more time than the initially allotted 2 months. The Bluetooth Buttons were trialed in several patients’ foot abduction orthoses to determine the validity of the Bluetooth temperature sensor (range of temperature recorded during use) and these temperature readings were then compared to the data obtained from the conventional thermochron iButtons implanted in the shoes’ inner soles.
Having refined the temperature range in the Bluetooth sensor in order to achieve valid readings of actual brace use, we have subsequently found that the software for the Bluetooth app has worked well with the iOS system of the iPhone. Unfortunately, it has not been reliable in the android smartphone. As such, we have not been able to enroll infants whose parents are android users. This has resulted in much fewer enrollees to date than was anticipated. At present, our software developers for this Bluetooth app are continuing to refine the platform that will accommodate both the iOS and Android systems. This process has been expensive and time-consuming.
In August 2019, we began enrolling clubfoot patients into this study. From that time to April 2021, we treated 163 new clubfoot patients at TSRH with the Ponseti method despite COVID-19’s severe impact on patient care over an extended period of time. Of these 163 patients, 75 of the patients’ parents were invited to enroll the babies into the study. 41 of these 75 patients’ parents agreed to enroll. Of the remaining 34 patients who did not enroll, the reasons given by parents for choosing not to enroll included being an Android user (BraceRite app did not work well with Android), not wanting their baby around Bluetooth technology, being “too busy”, or unstated.
Of the 41 clubfoot patients who did enroll, eight subsequently withdrew from this study. Reasons for withdrawal included the app did not work, skin irritation from the sensor occurred, or they moved out of state. Of the 33 patients remaining patients, four more were excluded because the Bluetooth sensors were not installed in the MDOrtho shoe as planned when the transition was made from casting to full-time bracing. 29 patients have remained in the study.
Of the 29 remaining patients enrolled in the study, currently two of them have finished the 1-3 month followup period, five have finished the 4-6 month followup period, three have
finished the 7-9 month followup period, and nineteen have finished the 12 month followup period.
Four physicians participated in this study. Full-time brace wear recommendations for the first three months were consistent among all physicians, followed thereafter by 12-hour per day recommendations by three physicians. One of the four physicians recommended full-time use for up to nine months. (This led to differences in expected time in the brace for some patients.)
Multiple unanticipated events occurred during this study’s timeframe, all of which had a detrimental effect on the iButton and BlueTooth app data.
1. With Covid-19 concerns, telehealth visits were utilized by families leading to gaps in the iButton downloads.
2. Research personnel were working remotely for months during the Covid-19 crisis, and were not available to work directly with patient families for study consent, in-person instructions on the use of the app, encouragement of participation, and for data downloads and collecting surveys.
3. BlueTooth problems occurred. We’ve struggled with having a consistent app over the course of this study and much of this time we were trying to create/improve the app instead of already having a finished version of the app. This led to instances where families either could not use the app (particularly Android users) or the data they were getting on the app was not accurate, which led to families not finding the app as a useful tool. Most of these issues were related to the app, but some were related to the Bluetooth button and the firmware in the button. Since the initiation of this study many changes have been made to both the app and the Bluetooth button in an attempt to improve functionality.
4. The sensor wasn’t placed in four shoes at the appropriate time during brace initiation. Sensor battery life was too short in some instances resulting in no information being transferred to the phone.
5. For parents with iOS phones and functioning apps, a number of them simply did not use the BlueTooth app to record information.
Available Results:
See iButton Excel sheet – Appendix 1
For those who wore the brace, most of them used them for the prescribed hours. About ¼ of the patients dropped out of data collection at some point in their treatment.
See BraceRite app Excel sheet - Appendix 2
Very little data was downloaded from the BraceRite app. Analysis of the limited data is not useful.
The concept of using information from the BlueTooth app to enhance the infants’ care was not realized.
Survey Questions:
A 5-question survey has been completed by 29/33 patients’ parents. These questions included:
1. Do you find the BraceRite clubfoot app useful? a) yes, always, b) yes, sometimes, c) I do not find it useful. If “c” is the answer, select why: the app is not working properly, I
forget to check/use the app, I do not feel I need to use the app to adhere to brace wear prescription, other. 2. Does the app help you adhere to brace wear prescription? a) yes, always, b) yes, sometimes, c) It does not help me adhere to the brace wear prescription.
3. Is the BraceRite clubfoot app easy to use? a) yes, always, b) yes, sometimes, c) I do not find it easy to use.
4. How often do you use the BraceRite clubfoot app? a) daily, b) weekly, c) monthly, d) rarely.
5. Additional feedback.
In view of the limited data that we obtained from the BraceRite app, we cannot correlate the responses to the five questions to BraceRite data. More extensive data was available from the iButton downloads. We ran statistical tests to see if responses to these questions were associated with any of the iButton data, and found no statistically significant differences in the associations between iButton data and responses to the questions.
Knowing that the BraceRite app did not work well with Android phones, we compared the parents’ responses to the questionnaire with their phone operating system (iOS vs Android). Did the type of phone make a difference in the perception of the BraceRite app? We found that here was no difference in positive response rates between iOS and Android (68.8% vs 62.5%, p-value>0.9).
Summary:
Over this two-year period of time, we have not been successful in demonstrating the anticipated usefulness of the BraceRite Bluetooth app to enhance compliance with brace wear in the nonoperative care for clubfeet.
