Adolescent Idiopathic ScoliosisNCT03292601
Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)
A study testing NYRC Brace Scoliosis Monitor in people with Adolescent Idiopathic Scoliosis, run by Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 17 years, women only
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- NYRC Brace Scoliosis Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2017to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
- Sanders skeletal stage 4 or earlier
- Clinician-recommended Rigo bracing
- Patient receiving brace treatment
Who cannot join
- Prior spine surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical Center
New York, New York, 10032
Mehdi Elfilali, BA, 212-305-9367, Mme2145@cumc.columbia.edu
Nicole Bainton, 212-305-5475, nme2103@cumc.columbia.edu
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- NYRC Brace Scoliosis Monitor
- Keywords
- Spinal Orthosis, Spinal Brace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NYRC Brace Scoliosis MonitorDevice
Also called Monitor
Scoliosis Monitor is a system that allows the continuous monitoring of the scoliosis brace use compliance and posture. This product includes a brace wearable that enables the monitoring of the scoliosis brace. The wearable device is able to communicate with a companion mobile application which stores and processes the collected data and is responsible for data synchronization.
| Study group | Role | What they receive |
|---|---|---|
| Feedback Group | Experimental | Participants will receive the standard-of-care scoliosis brace fitted with the compliance-monitoring study device and/or a temperature monitor (Orthotimer or iButton). The physician or a member of the research team will explain how the study device works to the patient and her/his parent. The physician or member of the research team will also explain the feedback mechanisms that exist to inform the patient that s/he has fit the device to the clinician-indicated appropriate tension and the online component of the program that allows for brace tension monitoring. Receives: Device: NYRC Brace Scoliosis Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wear Time Compliance
Measured as number of hours that the patient actually wore the brace.
Measured: Up to 1 year
Wear Compliance: Valid Hours
Measured as time (in hours) that the brace was worn to the provider-prescribed tightness
Measured: Up to 1 year
In-Brace Curve Correction Rate
In-brace curve correction will be analyzed by an in-brace radiograph to determine the degree of immediate curve correction (absolute change in degrees).
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start18 Oct 2017
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- (No Feedback Group was removed in 2019)
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Orthopaedic Society of North America
- Responsible party
- Sponsor
- Investigators
- Benjamin Roye, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292601
- Sponsor's protocol ID
- AAAP4760
- Status last verified
- Mar 2026
- First submitted
- 21 Sep 2017
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Feedback and Monitoring on Patient Compliance With Spinal Orthoses for Scoliosis Treatment
- ClinicalTrials.gov ID
- NCT03292601
- Acronym / sponsor ID
- AAAP4760
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Spinal Orthosis, Spinal Brace
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Pediatric Orthopaedic Society of North America
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- (No Feedback Group was removed in 2019)
| Arm | Type | Receives |
|---|---|---|
| Feedback Group | Experimental | Device: NYRC Brace Scoliosis MonitorParticipants will receive the standard-of-care scoliosis brace fitted with the compliance-monitoring study device and/or a temperature monitor (Orthotimer or iButton). The physician or a member of the research team will explain how the study device works to the patient and her/his parent. The physician or member of the research team will also explain the feedback mechanisms that exist to inform the patient that s/he has fit the device to the clinician-indicated appropriate tension and the online component of the program that allows for brace tension monitoring. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
- Sanders skeletal stage 4 or earlier
- Clinician-recommended Rigo bracing
- Patient receiving brace treatment
Key exclusion criteria (1 listed)
- Prior spine surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NYRC Brace Scoliosis MonitorAlso: MonitorScoliosis Monitor is a system that allows the continuous monitoring of the scoliosis brace use compliance and posture. This product includes a brace wearable that enables the monitoring of the scoliosis brace. The wearable device is able to communicate with a companion mobile application which stores and processes the collected data and is responsible for data synchronization. | Device | Feedback Group |
Primary outcome
Wear Time Compliance
Time frame: Up to 1 year
Measured as number of hours that the patient actually wore the brace.
Wear Compliance: Valid Hours
Time frame: Up to 1 year
Measured as time (in hours) that the brace was worn to the provider-prescribed tightness
In-Brace Curve Correction Rate
Time frame: Up to 1 year
In-brace curve correction will be analyzed by an in-brace radiograph to determine the degree of immediate curve correction (absolute change in degrees).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Roye, MD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NYRC Brace Scoliosis Monitor in people with Adolescent Idiopathic Scoliosis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin D. Roye, MD, MPH ((212) 305-5475, bdr5@columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wear Time Compliance (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.