Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 8 - 17 |
| Updated: | 2/3/2019 |
| Start Date: | October 18, 2017 |
| End Date: | December 2019 |
| Contact: | Benjamin D. Roye, MD, MPH |
| Email: | bdr5@columbia.edu |
| Phone: | (212) 305-5475 |
Effect of Feedback and Monitoring on Patient Compliance With Spinal Orthoses for Scoliosis Treatment
The overall aim of the study is to utilize a novel device and smartphone application in order
to improve measurement of patient compliance with at-home bracing for scoliosis as well as
create a more accurate assessment of brace fit via continuous and objective measures of
tension. These ground-breaking metrics will provide analyzable data to more accurately
reflect and predict actual patient compliance as well as allow for further exploration of how
to increase compliance, and thus, efficacy of bracing; it will additionally allow both
physicians and patients to have a more reliable measure for brace fit by providing them with
continuous data of fit via tension, and provide built-in feedback mechanisms to the patient
to ensure proper tightness of the brace.
Additionally, the study will investigate whether providing the wearer's own brace-wear
compliance information directly to the patient and their caregiver(s) via the mobile app will
further improve rates of compliance as compared to those who do not receive the same feedback
mechanism.
to improve measurement of patient compliance with at-home bracing for scoliosis as well as
create a more accurate assessment of brace fit via continuous and objective measures of
tension. These ground-breaking metrics will provide analyzable data to more accurately
reflect and predict actual patient compliance as well as allow for further exploration of how
to increase compliance, and thus, efficacy of bracing; it will additionally allow both
physicians and patients to have a more reliable measure for brace fit by providing them with
continuous data of fit via tension, and provide built-in feedback mechanisms to the patient
to ensure proper tightness of the brace.
Additionally, the study will investigate whether providing the wearer's own brace-wear
compliance information directly to the patient and their caregiver(s) via the mobile app will
further improve rates of compliance as compared to those who do not receive the same feedback
mechanism.
The current method to set brace tension is subjective; it is limited to the attending
clinician making a mark on the brace straps, to which the patient tightens the straps during
daily wear. Once the strap is set in place, the current standard-of-care does not involve any
more monitoring. Therefore, ideal strap tension is unknown and the effectiveness of bracing
may be unknowingly compromised by many as yet unidentified variables. In recent years, a
small number of studies have emerged related to the strap tension of bracing yet no clear
guidelines on correct strap tension currently exist. Considering the potential effects on
preventing scoliosis progression and brace-associated complications, the need for guidelines
regarding optimal brace fit are greatly needed for clinical use. Via this brace monitoring
study, continuous monitoring of tension at brace fitting, throughout the day, and related to
positional changes will be possible with a very minimal device and smartphone application.
The tremendous amounts of data generated by the device and its app will be used to create a
database from which our team will gather information about brace wear compliance and use
tension information for the development of standards for effective strap tension associated
with greater scoliosis curve correction. Lastly, the effect of a patient's engagement with
his or her brace - through the smartphone app - will be examined. It is well established in
the literature that observation increases compliance, but no studies investigating patient
self-monitoring through personal devices currently exists. This is a vital area of
investigation given the recent explosion in personal health-assessing devices e.g. the Apple
watch, Up band, fitbit, etc.
clinician making a mark on the brace straps, to which the patient tightens the straps during
daily wear. Once the strap is set in place, the current standard-of-care does not involve any
more monitoring. Therefore, ideal strap tension is unknown and the effectiveness of bracing
may be unknowingly compromised by many as yet unidentified variables. In recent years, a
small number of studies have emerged related to the strap tension of bracing yet no clear
guidelines on correct strap tension currently exist. Considering the potential effects on
preventing scoliosis progression and brace-associated complications, the need for guidelines
regarding optimal brace fit are greatly needed for clinical use. Via this brace monitoring
study, continuous monitoring of tension at brace fitting, throughout the day, and related to
positional changes will be possible with a very minimal device and smartphone application.
The tremendous amounts of data generated by the device and its app will be used to create a
database from which our team will gather information about brace wear compliance and use
tension information for the development of standards for effective strap tension associated
with greater scoliosis curve correction. Lastly, the effect of a patient's engagement with
his or her brace - through the smartphone app - will be examined. It is well established in
the literature that observation increases compliance, but no studies investigating patient
self-monitoring through personal devices currently exists. This is a vital area of
investigation given the recent explosion in personal health-assessing devices e.g. the Apple
watch, Up band, fitbit, etc.
Inclusion Criteria:
- Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
- Sanders skeletal stage 4 or earlier
- Clinician-recommended Rigo bracing
- Patient receiving brace treatment
Exclusion Criteria:
- Prior spine surgery
We found this trial at
1
site
3959 Broadway
New York, New York 10032
New York, New York 10032
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