A Randomized Clinical Trial of Brace Treatment

December 16, 2024 updated by: University of Alberta

Brace treatment is the most effective non-surgical method for the treatment of Adolescent idiopathic scoliosis (AIS). The goal of bracing is to stop the curve progression during the high risk period of the adolescent growth spurt. A spinal brace is a hard plastic shell with pressure pads installed inside the liner to provide mechanical support to the curvature of the spine. It is a big commitment for adolescents to wear a brace because it is physically restrictive, uncomfortable and draws unwanted attention. Therefore, it is very important to make the brace treatment as effective as possible to get patient buy-in to compromise their lifestyle by wearing a brace. Patients' belief in the treatment outcomes is also a factor to attain their compliance.

This randomized clinical study will investigate if the effectiveness of brace treatment can be maximized by combining ultrasound imaging assistance during brace design with the smart brace to automatically maintain corrective brace pressures at the optimum level during the whole treatment period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: Brace treatment is the most effective non-surgical method for the treatment of AIS. The goal of bracing is to stop the curve progression during the high risk period of the adolescent growth spurt. A spinal brace is a hard plastic shell with pressure pads installed inside the liner to provide mechanical support to the curvature of the spine. It is a big commitment for adolescents to wear a brace because it is physically restrictive, uncomfortable and draws unwanted attention. Therefore, it is very important to make the brace treatment as effective as possible to get patient buy-in to compromise their lifestyle by wearing a brace. Patients' belief in the treatment outcomes is also a factor to attain their compliance.

Study Objective: This randomized clinical study will investigate if the effectiveness of brace treatment can be maximized by combining ultrasound imaging assistance during brace design with the smart brace to automatically maintain corrective brace pressures at the optimum level during the whole treatment period.

Methodology:

Subject Selection: One hundred and twenty-eight brace candidates with AIS will be recruited over the next 5 years. During the scoliosis clinic, the attending orthopaedic surgeon identifies a potential candidate. He will ask the potential patient if he/she is interested in speaking with the research coordinator about research projects that he/she is eligible. The inclusion criteria are patients 1) age 10 - 16 years, 2) diagnosis of AIS, 3) require full-time brace wear, 4) Cobb angle between 20° - 40°, 5) Risser sign ≤3 and 6) premenarchal or less than 1 year postmenarchal. Subjects will be randomly selected to 1 of the 2 groups: a) An ultrasound assisted designed brace and a brace monitor, and b) An ultrasound assisted designed brace and a smart brace device. Figure 1 shows the flow chart of the study. Each subject will have 50% chance of being in any one of the groups. An extra 15 minutes will be needed for both groups during the brace fitting clinic to install the brace monitor or smart brace device. An extra 30 minutes will be added to your casting. Participants will be monitored until the brace treatment is finished.

Detailed description: The brace monitor is a small electronic device which will be embedded inside the brace. It is a very low power system operating at 3.3 V and 2 milliampere (mA) (on average). It is able to store 12 months of data and the battery can last for 9 months. It will record how much time and how tightly the subject wears the brace. The brace with the monitor looks exactly the same as a standard brace. The subject won't feel any different and don't need to do anything beyond. We will replace the monitor with a new one at every standard follow up clinic.

A smart brace device is a small electronic device. It will have a small air bag embedded at the major pad area covered with stretchable leather. It will record how much time and how tightly the brace is worn. The air bag will inflate if the contact pressure between the brace and the body is lower than expected. The air bag will deflate if the contact pressure between the brace and the body is higher than expected. This automatic pressure adjustment will only be activated during daytime which is individualized based on the patient's sleep pattern. The system will also be activated only if breathing motion is detected (which means brace is worn). The smart brace monitor is able to store 6 months of data but requiring to recharge every day for 30 minutes. The smart brace monitor is a low power system (operating at 4.2 V and 150 mA max). It has an on-off switch and a pressure enable-disable regulation switch safety functions. Switching enable-disable regulation to off will make the smart brace device becomes a standard brace monitor. Turing off the on-off switch will disable all the functions and this brace will become a standard brace. We will replace the monitor with a new one at every standard follow up clinic.

The ultrasound assisted design requires to get 4 ultrasound images: normal standing, normal supine, bending left supine and bending right supine. Each scan takes approximately 1 minute. These 4 scans will provide spine flexibility information. After this, the subject will be asked to stand in a wooden positioning frame with pressure pads allow to move 3-dimensionally. Multiple adjustable brace pads will be applied to the patients' body according to orthotist suggestion. An ultrasound scan will be performed after the pads are applied. The orthotist will use the ultrasound image to decide if the pads are at the optimum locations and applied proper pressures. If the orthotist is satisfied with the correction, he/ she will use this setup to build the brace. Otherwise, he/she will adjust the position and orientation of the pads and repeated the ultrasound scan.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. age 10 - 16 years
  2. diagnosed of AIS
  3. require full-time brace wear
  4. have Cobb angle between 20° - 40°
  5. have Risser sign ≤3
  6. premenarchal or less than 1 year postmenarchal.

Exclusion Criteria:

  1. patients who require surgery
  2. presenting with associated musculoskeletal, neurological or other conditions possibly responsible for the curvature
  3. physical or mental disability that prevent patients from complying with the bracing protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Monitor Only
A brace monitor will be embedded inside the brace to monitor compliance.
Device: Active Brace system
Active Comparator: Active Brace System
An active brace device will be embedded inside the brace to dynamically control interface pressure and monitor compliance.
Device: Active Brace system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effectiveness of active brace treatment
Time Frame: 2 years after completing the brace treatment
The proportions of successful treatment between two arms b to determine the overall effectiveness
2 years after completing the brace treatment
Immediate Active effect
Time Frame: 1 year after enrollment
Review the out of brace Cobb angle 1 year after using the spinal brace
1 year after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00058476

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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