Green Sun Medical Dynamic Scoliosis Brace
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Sponsor: Green Sun medical

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Pilot Trial Green Sun Medical Dynamic Brace 
Sponsor:  Green Sun Medical 
Co-Investigator:  Lori A. Dolan, PhD 
NCT # 03641469 
 
STATEMENT OF COMPLIANCE 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the Institutional Review Board (IRB) for review and approval.  Approval of both 
the protocol and the consent form must be obtained before any participant is enrolled.  Any 
amendment to the protocol will require review and approval by the IRB before the changes are 
implemented to the study.  In addition, all changes to the consent form will be IRB-approved; a 
determination will be made regarding whether a new consent needs to be obtained from 
participants who provided consent, using a previously approved consent form. 
 
 

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1 PROTOCOL SUMMARY 
1.1 SYNOPSIS 
Title: 
Pilot Study of the Green Sun Medical Dynamic Brace  
Study Description: 
Preliminary investigation of safety and performance 
Objectives: 
Preliminary Safety and Performance of Green Sun Medical brace 
(GSM). 
  
Endpoints: 
Safety – ongoing review 
Performance:  In-brace Cobb angle correction and Cobb angle 
progression  
Study Population: 
Adolescent idiopathic scoliosis (AIS) patients currently treated with a 
standard of care thoracolumbosacral orthosis (TLSO) 
Phase: 
  
Description of 
Sites/Facilities Enrolling 
Participants: 
Multiple sites across the United States 
Description of Study 
Intervention: 
Green Sun Medical (GSM) brace 
Study Duration: 
unknown 
Participant Duration: 
variable 
Optional Substudy 
Pressure-Sensor Equipped Pad Clinical Validation 
  
 
 
 
1 INTRODUCTION 
1.1 STUDY RATIONALE 
The Green Sun Medical Dynamic Brace (GSM) brace was developed as an alternative to rigid 
thoracolumbosacral orthoses (TLSOs, braces) commonly used to prevent continued curve 
progression in patients with adolescent idiopathic scoliosis (AIS).  The brace applies corrective 
forces to the muscular and bony structures of the spine while preserving range of motion 
(ROM).  The orthosis is prefabricated and adjusted for each patient.  A series of semi-rigid 
segments encircle the patient’s torso in close contact and are joined by a structure of flexible 
elements. These flexible (or elastic) elements generate stabilizing forces, providing the 
necessary immobilization while allowing relative motion of the semi-rigid segments.  To date, 
this brace has been tested in the lab on healthy volunteers.   

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The innovative design of this brace should provide an equivalent degree of correction of the 
scoliotic curvature as a rigid TLSO, with increased acceptability to the patient via improved 
comfort and spinal/chest wall mobility. Increased acceptability promotes increased adherence 
to treatment.  Given the strong research evidence that bracing effectiveness is a function of 
correction and adherence, there is reason to believe that a future pivotal study of the GSM 
brace could demonstrate superior effectiveness to rigid TLSO designs.   
 
This is a pilot study to collect preliminary short-term data concerning the safety and 
performance of the GSM brace in a sample of subjects with AIS who are currently being treated 
with a TLSO.   
1.2 BACKGROUND 
Adolescent Idiopathic Scoliosis  
Adolescent idiopathic scoliosis is a structural lateral and rotatory curvature of the spine arising 
in otherwise normal children during puberty.  Curvatures less than 10 degrees are viewed as a 
variation of normal because until a curvature has exceeded 10 degrees, it has little potential for 
progression.  The 1982 report of the Scoliosis Research Society 1 stated that 2-3 percent of 
children younger than 16 years of age will have a curvature of 10 degrees or less, but only 0.3-
0.5 percent will have a curvature of 20 degrees of more. The vast majority of AIS patients do 
not initially present due to symptoms, but due to the finding of truncal asymmetry noted during 
screening or incidentally during well-child examinations.  Long-term follow-ups indicate that the 
population may have a higher prevalence of back pain, and of respiratory compromise if the 
curve becomes extremely large. 2 Therefore, the treatment of AIS during adolescence is mainly 
an attempt to prevent problems during adulthood by arresting the progression of the curve.  
Additionally, large curves are generally acknowledged to cause significant cosmetic deformity 
and associated psychological distress.  Such deformity can only be corrected through surgery.  
Thus, many patients seek and receive essentially prophylactic non-operative treatment 
(bracing) for AIS.   
 
Biomechanics of Adolescent Idiopathic Scoliosis and Bracing  
Two major biomechanical principles are thought to contribute to the development and 
progression of AIS:  Euler’s theory of elastic buckling of a column; and the effect of the Hueter-
Volkmann principle of vertebral body growth.  Euler’s theory, as applied to AIS by Gavin, Shurr 
and Patwardhan,3 conceptualizes the vertebral column as a straight, flexible column fixed at the 
base, free at the upper end, and subjected to an axial compressive force.  There exists an upper 
limit of the magnitude of this force at which point the column will buckle; this force is a 
function of its flexibility, length, and end support conditions.  Due to the lateral curvature of the 

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scoliotic spine, an axial compressive load at the top results in internal bending moment and 
causes deformation of the curved column.  If the axial load is removed, the curve will return to 
its original shape through an elastic response.  This response is in keeping with the observation 
that curves are smaller with the patient in a supine vs. standing position.  As the axial load is 
increased, the internal stresses increase, and there is further increase in the deformation of the 
column.  At some point, the axial load may become large enough to cause the bending moment 
in the column to exceed the elastic limit and cause plastic, permanent deformity.  The axial load 
sufficient to cause plastic deformation is termed the critical load of the column and is a function 
not only of the curve flexibility, length and support conditions, but also of the magnitude of the 
initial curvature.  The larger the curve, the smaller the critical load, and therefore, the more 
likely large curves are to progress than smaller ones.  
 
The action of a TLSO can be explained using the above principle of plastic buckling as three 
separate, but interactive, components:  end-point control, transverse loading, and curve 
correction.  Endpoint control describes the stabilizing forces placed on the pelvis by the orthosis 
that provide an increase in the critical load of a spinal curve.  Another characteristic of scoliosis 
orthoses is some form of a transversely directed load on the apex of the curvature, through 
accessories such as slings and pads, or through the molding of a full-contact orthosis. The use of 
transverse forces alone directed at the apex of the curve increases the critical load the spine 
can carry and may be sufficient to prevent the curve from further progression.  The curve 
correction produced by an orthosis has the single greatest effect on increasing the overall 
critical load of the spinal column.  For example, reducing a curve from 30 degrees to 20 degrees 
increases the critical load from 50 percent to 80 percent.  The results of the combined effects of 
these mechanisms are additive.  Utilizing the proper biomechanical forces will theoretically 
allow any TLSO to achieve optimum correction.  
 
Use of Bracing in AIS  
Several brace designs have been proposed based on these biomechanical principles. Modern 
spinal braces began with the development of the Milwaukee brace.  The Milwaukee brace, a 
cervicothoracolumbosacral orthosis, was first used as a post-operative device, then became the 
mainstay of non-surgical treatment for scoliosis in the 1960s. Although this brace is still in use 
for certain curvatures, lower profile rigid thoracolumbosacral orthoses (TLSOs) are now most 
frequently used.  TLSOs were primarily designed to circumvent the objectionable characteristics 
of the Milwaukee, including a lower profile without the cervical extension, the use of lighter 
materials, and customization to the individual to improve comfort and cosmesis. 4 Despite these 
changes, TLSOs are poorly tolerated by many patients.  Sanders and colleagues stated “many 
factors likely contribute to the low overall compliance with bracing, including comfort, social 

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issues and self-image.  Some patients may decide that the risk of progression to surgery is more 
acceptable than wearing a brace.” 5 
 
TLSOs are usually prescribed for curves with an apex caudal to the seventh thoracic vertebra, 
with a magnitude greater than 25 degrees and less than 45 degrees, or 20 degrees plus 
documented progression of greater than 5 degrees over 6 months in skeletally immature 
patients. 16 Some TLSOs have been developed for use only at nighttime or part-time (e.g. 
Providence and Charleston bending braces), while most others are worn 18 or more hours per 
day. Although TLSOs differ slightly in their design, all were developed based on the same 
principle of three-point control with the goal of correcting the curve in the brace, and stabilizing 
it throughout the duration of wear. 6 Curve correction is both a function of brace construction 
and of the characteristics of the individual curve, such as its severity and flexibility.   
 
Despite a large body of research literature, the question of TLSO effectiveness wasn’t 
definitively answered until 2013, when the results of the Bracing in Adolescent Scoliosis Trial 
(BrAIST) were published. 7 The use of a TLSO significantly reduced the incidence of curve 
progression to surgical threshold, relative to no treatment, in both the randomized and 
observation arms of the study.  Additionally, a strong dose-response curve was noted, 
demonstrating that increasing average hours of wear per day decreases the risk of significant 
curve progression.  The dose-response relationship is supported by several other studies, and 
evidence is emerging that longer hours of wear are required by younger patients with larger 
Cobb angles, who are at higher risk of curve progression. 8-11  Unfortunately, clinical experience 
and objective monitoring of wear time indicates that compliance/adherence is a serious issue in 
bracing treatment. 6, 12-14. In the BrAIST study, 7 the median wear time was 13 hours per day, 
despite prescription of a minimum of 18 hours per day.  Adherence improves when optimal 
levels of education and support are provided to patients and when barriers, such as comfort 
and appearance, are addressed. 9, 15-17  
 
The amount of Cobb angle correction obtained in the brace has also been linked to treatment 
outcomes.  Historically, the goal has been in-brace correction of at least 50%, 18, 19 although 
successful outcomes have been shown with correction ranging from 10-50% or greater. 20-24 The 
amount of correction a TLSO can achieve is enhanced by appropriate customization, starting 
with accurate measurements of both the patient’s trunk and their specific curve pattern and 
magnitude. 25 But the amount of correction achievable from even an optimally designed TLSO is 
limited by patient and curve characteristics which contribute to the stiffness of the curve.  
Therefore, comparison of correction between brace designs may best be demonstrated by 
within-patient differences if randomization to treatment with large samples is not possible.  
 

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It is clear that a high percentage of patients experience curve progression and subsequent 
spinal fusion surgeries which may have been prevented if appropriate corrective forces and 
adequate wear time had been achieved.   
1.3 GSM BRACE 
Green Sun Medical Dynamic (GSM) Brace (also known as the Green Sun Medical Whisper 
Brace™) 
The GSM Dynamic External Orthosis is an externally applied device designed specifically for use 
with AIS and other spinal deformity patients.  The GSM brace, like a TLSO, applies corrective 
forces at the apices of the scoliosis and supports the muscular and bony structures of the spine.   
 
The engineering team designed the device to provide clinically-relevant forces and moments 
equivalent to those generated by TLSOs 26 while addressing issues with current rigid bracing 
technology. Addressing these barriers to successful bracing outcomes is critical. Failure of 
conservative therapy for AIS may result in spinal fusion, a major procedure that fuses an 
average of 10 vertebrae and results in expensive hospitalizations and the potential for life-long 
complications.  
Key differences between the GSM brace and TLSOs are: 
Issue 
Rigid Bracing 
GSM Dynamic Orthotic 
Range of Motion 
Extremely limited in spinal motion 
during brace wear results in 
patient discomfort, muscular 
atrophy and reduced compliance 
Allows range of motion, 
potentially improving patient 
comfort, paraspinous muscle 
tone and compliance 
Curve Correction 
Designed to prevent deformity 
progression 
Ability to correct curvature limited 
by drop-off in support forces with 
any correction 
Designed to minimize force 
drop-off with correction 
Sustained corrective forces 
could potentially offer 
improvement of the spinal 
deformity 
Accommodate Growth 
Patient growth can result in 
altered support forces, reduced 
brace performance, discomfort 
and require new brace fabrication 
Designed to accommodate 
growth 
Modular nature allows device 
to accommodate growth with 
minimal effort and cost 
Ease of Fabrication and 
Adjustment 
Most rigid braces fashioned by 
hand 
Fit issues or failure to achieve 
significant in-brace correction can 
result in re-fabrication 
Limited ability to adjust with 
padding 
Modular components and 
adjustable force mechanisms 
allow rapid adjustments to fit 
patient anatomy and in-brace 
correction 

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The design of the GSM brace utilizes a series of semi-rigid segments that encircle the patient’s 
torso in close contact joined by a structure of flexible elements. These flexible (or elastic) 
elements generate the necessary corrective forces while allowing relative motion of the semi-
rigid segments. The orthosis is minimal in appearance and worn under the patient’s garments.   
 
The GSM brace also includes an integrated sensor system which allows the continuous 
collection of movement and pressure data for the purposes of tracking brace wear and 
effectiveness.  Initially, the data are intended for information only while the system and 
algorithms are validated.  The sensor system is comprised of the following: 
• Hardware: The sensor system hardware includes a Bluetooth Low Energy (BLE) 
microcontroller board with rechargeable battery, 3-axis accelerometer, and an array of 
piezoresistive pressure sensors integrated into key locations on the orthosis.  The board 
stores data in its internal memory.   
• Software: The sensor system firmware samples accelerometer and pressure sensor data 
and writes to the board’s internal memory.  More than 60 days of data can be retained 
between syncs.   
Please see the Investigator’s Brochure for additional details concerning the development of the 
device.  FDA classification:  Sec. 890.3490 Truncal orthosis, Class I device, and is exempt from 
premarket notification and current good manufacturing practice requirements.  The GSM brace 
is a non-significant risk device.  The FDA defines a significant risk device under 21 CFR 812.3(m) 
as having the following uses and characteristics: 
 
1) Is intended as an implant and presents a potential for serious risk to the health, safety, 
or welfare of a subject;  
2) Is purported or represented to be for use supporting or sustaining human life and 
presents a potential for serious risk to the health, safety, or welfare of a subject;  
3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating 
disease, or otherwise preventing impairment of human health and presents a potential 
for serious risk to the health, safety, or welfare of a subject; or  
4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a 
subject.   
 
The FDA defines serious risk as potential harm to subjects that could be life-threatening, could 
result in permanent impairment of a body function, or permanent damage to body structure, or 
could necessitate medical or surgical intervention to preclude permanent impairment of a body 
function or permanent damage to body structure. 
 

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A non-significant risk device is any device that does not meet those criteria. The GSM brace 
does not meet the criteria defined in 1 and 2 above. While the device is intended for treating 
the disease of scoliosis, it, like other TLSO’s, does not pose a serious risk to the patient.  The 
GSM Dynamic Orthosis is a brace worn externally over the torso of a patient. It has been 
designed to provide forces of similar magnitude to current standard-of-care braces. 
 
2 OBJECTIVES AND ENDPOINTS 
Primary 
1.  Safety of the GSM brace:  To identify unanticipated adverse events associated with the 
GSM brace and patient characteristics likely to raise safety issues 
2.  Performance of the GSM brace:  
a. To assess immediate radiographic outcomes (in-brace Cobb angle) relative to 
those in the TLSO 
b. To assess short-term radiographic outcome (out of brace Cobb angle) after 3 
months 
c. To assess adherence to the bracing prescription (hours of wear per day) 
d. To assess patient-reported outcomes including health-related quality of life and 
measures of acceptability of the GSM brace (e.g. comfort, stress, interference 
with activities) relative to experiences in the patient’s previous TLSO 
 
Secondary 
1. To assess spinal range of motion in the GSM brace relative to the subject’s TLSO 
2. To assess lung vital capacity in the GSM brace relative to the subject’s TLSO 
3. To validate accelerometer data (obtained from an embedded sensor in the GSM brace) 
as an estimate of the average hours of wear per day. 
3 STUDY DESIGN 
3.1 OVERALL DESIGN 
This is a pilot study to provide "proof of concept" data which will inform further refinements of 
the GSM brace and support the development of a subsequent pivotal multicenter clinical trial.   
 
Our primary aims involve safety and performance.  
 
This is a multi-center, open-label trial where subjects serve as their own controls.  Baseline 
radiographic and patient report will reflect the effect of the subject’s standard of care TSLO, 
providing data that can be directly compared to that obtained during use of the GSM brace.  

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4 STUDY POPULATION 
4.1 INCLUSION CRITERIA AND EXCLUSION CRITERIA 
Inclusion criteria are as follows: 
1) Diagnosis of AIS 
2) Current treatment with a TLSO, of ≥5 months’ duration 
3) Existing 3D surface scan of torso and out-of-brace x-ray within the past 6 months.  If no scan 
exists, patient must be willing to undergo a scan to allow fabrication of the GSM brace.   
4) One curve apex below T7  
5) Female sex (85% of the AIS population is female) 
6) Ability to read and write English 
7) Age 10-15 years 
 
Exclusion criteria: 
1) Parents/patients who decline participation and/or do not sign the consent/assent documents   
2) Pregnant women 
3) Patients who are unwilling or unable to return for follow-up visits 
4) Patients who are unable to read and write in English. 
4.2 SCREEN FAILURES 
Other than the pregnancy test, there will be no screening for participation after informed 
consent/assent is signed.   
4.3 STRATEGIES FOR RECRUITMENT 
1.  Identification 
Potential subjects will consist of patients currently being treated at a study center.  We 
estimate that at any given time, the sites are treating approximately 60 patients who would 
meet the inclusion criteria.   
 
Under a partial HIPAA waiver or other institutional authorization allowing examination of 
records for research screening, study staff will identify patients who meet the inclusion criteria 
using the results of their most recent clinical visit and their orthotic care to date.  To otherwise 
approach all patients would be impractical due to the large volume of patients seen in the clinic 
who do not meet these criteria (i.e. patients with other diagnoses, adults, or patients with 
other characteristics outside the inclusion criteria).  If the patient meets the inclusion criteria, 
her name and contact information will be entered into an electronic log.  Once the patient 

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makes a decision about participation, the entry will be deleted.  The entire log will be deleted 
once study data collection is completed.   
 
2. Recruitment 
Recruitment can occur in two ways.   
 
1)  Patients encountered in clinic.  If a patient meets the inclusion criteria, study staff will 
introduce the study and answer questions.  The family will be given the option to see the GSM 
brace, and further discuss the study prior to enrolling.  If the family is interested in the study, 
study staff will go over the Informed Consent and Assent documents with the family, and 
answer any questions they may have.  The family will be given the opportunity to see the GSM 
brace.  Families will be encouraged to take as much time as they need to consider participation.  
No study procedures will occur until signed consent/assent is obtained.   
 
2) Patients identified via a search of medical records.  If a patient meets the inclusion criteria, 
study staff will mail out an introductory letter with an overview of the study and copies of the 
Informed Consent and Assent documents (See Introductory Letter).  One week later, study staff 
will call the family and introduce the study (See Introductory Phone Script).  The voluntary 
nature of the study will be emphasized and parents/patients will be assured that declining 
participation will not impact their continued care.  The family will be given the option to see the 
brace, and further discuss the study prior to enrolling by visiting the clinic.  Families will be 
encouraged to take as much time as they need to consider participation.  If the family is 
interested in the study, during the introductory phone call, study staff will read the Informed 
Consent and Assent documents with the family, and answer any questions they may have.  
Consent/assent could be obtained either via the mail or in person. No study procedures will 
occur until signed consent/assent is obtained.   
 

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5 STUDY INTERVENTION 
5.1.1 STUDY INTERVENTION SUMMARY FLOWSHEET 
 
 
 

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5.1.2  STUDY PROCEDURES 
 
Immediately After Consent is Signed and Received by Study Team 
The following will be sent to Green Sun so that an appropriately-configured GSM brace can be 
made for the subject:  
1) 
A de-identified copy of the most recent 3D scan of the patient’s torso (tagged with a 
study ID number) 
2) 
The individualized treatment plan devised by the PI which specifies the location and 
direction of applied forces (e.g. push on the patient’s left axilla, push on the patient’s 
right rib cage roughly 4 inches lateral of midline around T9) and tagged with a study ID 
number 
The Baseline Visit will be scheduled approximately 2 weeks after consent is signed and the 3D 
scan and treatment plan have been sent to Green Sun to allow Green Sun time to fabricate the 
brace. 
 
Instructions for Radiographs 
1. All study-related radiographs will be obtained using the EOS® Imaging system Micro 
Dose protocol (when available). If an EOS system is not available, please see Additional 
Information on Assessments.  Radiographs and Assessments, and 5.2.1 Risks for further 
information).   
2. The number of study-related radiographs is NOT to exceed 6. 
3. Three radiographs are required:  
a.  In the TLSO (Baseline Visit 1) 
b.  In the GSM (Visit 2) 
c.  Out of brace (Visit 3) 
4. A maximum of 3 optional in-brace radiographs may be taken at any time prior to Visit 3 
to maximize the fit, correction and comfort of the GSM brace.   
 
Baseline Visit 1 (approximately 2 hours) 
1. A urine pregnancy test will be conducted.  Pregnant subjects will exit the study. 
2. Completion of the Brace Questionnaire and the Italian Spine Youth Quality of Life 
(ISYQOL) questionnaire (5 minutes) 
3. Assessments while wearing current TLSO 
a. Vital capacity using Spiropet spirometer (average of 3 trials, 5 minutes) 
b. Measurement of spine range-of-motion (flexion, extension, rotation) using a 
tape measure (5 minutes) 

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c. In-brace standing coronal full-spine radiograph (5 minutes) 
4. The subject will be fitted with the customized GSM brace.  The fit and corrective forces 
will be fine-tuned by adjusting the drive mechanisms until the corrective forces are 
matched to the surface anatomy of the patient and to the spinal deformity.  The subject 
is involved in this process by providing feedback concerning the comfort of the brace. A 
log will be kept of all adjustments made to the brace during the course of the study.  
The brace will include the embedded force and acceleration sensors, as well as two 
temperature monitor units.   
5. Assessments while wearing Green Sun Brace 
a. Vital capacity using Spiropet (average of 3 trials, 5 minutes) 
b. Measurement of spine range-of-motion (flexion, extension, rotation) using a 
tape measure (5 minutes) 
6. Subject sent home with daily GSM Brace Diary 
7. Extraction of data from medical/orthotic records:  date of birth, gender, date of menses 
onset, and historical measures of height, weight, skeletal maturity (Risser grade, status 
of triradiate), Scoliosis Research Society curve classification, Cobb angle(s), kyphosis, 
lordosis, coronal and sagittal balance, apical vertebral rotation, in-brace Cobb angle(s) 
and estimated brace wear time.  Data from TLSO brace initiation to baseline study visit 
will be extracted.  These data define the spinal deformity, and the risk for continued 
progression.  
8. OPTIONAL:  Subject Appraisal of the GSM Brace Wear Mobile App 
Subjects will be given the option to use and provide feedback concerning the GSM 
mobile app (Dynamic Scoliosis Brace Monitoring App, Version 1.5.1, developed by Green 
Sun Medical and Mindset Medical).  This app pairs the subject’s mobile device with the 
GSM sensor in the brace and offloads date, accelerometer and pressure sensor data to 
estimate the number of hours per day that the brace is being worn by the patient.  The 
app graphically displays the estimated hours/day the brace was worn for the current 
day and for the week.  The app provides real-time feedback using graphical displays that 
should be easily understandable by adolescents.  There is research evidence that 
providing subjects with brace wear time feedback results in better compliance to brace 
wear recommendations. 9, 16 Subjects will be given the option to use the app and to 
complete the GSM App feedback form at Visit 2 and Visit 3.  The purpose of the app in 
this study is not to assess brace wear time or the influence of the app on wear time, but 
only to gather subjects’ opinions for ongoing refinement of the app.  The accuracy or 
reliability of the app is not being tested in this study.  Subject PHI will not be used for 
registration; subjects will be instructed to enter their Study ID and City instead of their 
First and Last names; DOB as January 1, 2019; their email will be entered as the 

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StudyID@greensunmedical.com.  More information about the app is provided in the 
section:  Additional Information on Assessments 
 
Visit 2 (1-2 weeks after Baseline, approximately 1 hour)  
1) Standing coronal full-spine radiographs in the GSM brace (5 minutes). 
2) Completion of GSM App Feedback Questionnaire (optional) 
3) Safety Check:  Query for adverse events and other issues 
4) Performance Check 
a) If the Cobb angle obtained in the GSM brace is less than, or no more than, 10 
degrees greater than that measured in the TLSO (measurement from Baseline 
Visit 1) then the GSM in-brace correction will be considered equivalent to the 
standard brace, and the subject will be sent home for a 2-week trial of the GSM 
brace 
b) If the in-brace Cobb angle is >10 degrees than that in the TLSO, the subject will 
exit the trial and continue with their current TLSO. 
5) The subject will be provided with 1) instructions for removal and return of 1 
temperature monitor at 2 weeks, 2) an extra sensor system rechargeable battery and 
charger, with instructions for use, 3) mailing labels and envelopes, and 4) GSM brace 
diaries. 
 
Phone Visit and Performance Check (2 weeks after baseline) 
1.  Study staff will contact the subject and parent/guardian to see how well the subject 
is adapting to the GSM brace and remind the subject/parent to remove the temperature 
monitor from the brace and send by courier overnight to the study site. 
2.  Safety Check:  Query for adverse events and other issues 
3.  Performance Check – to ensure adherence to prescribed number of hours per day in 
the GSM brace:  
1. If any problems are noted during the phone contact the PI will determine 
whether adjustments to the brace could alleviate the issues and, if so, ask the 
subject return to clinic  
2. If the temperature monitor data indicate the subject is wearing the GSM brace 
an average of 2 or more hours less per day than prescribed 
a. The PI will determine whether adjustments to the brace could alleviate the 
issues and have the subject return to clinic; if not, the subject will exit the 
study and return to their current TLSO 
b. If after adjustments to the brace, the subject feels that the brace is still 
incompatible with the prescribed wear time, the subject will exit the study 
and return to their current TLSO 

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Phone Visits (Weeks 4, 6, 8, and 10 after baseline) 
1.  Study staff will contact the subject and parent/guardian to see how well the subject 
is adapting to the GSM brace and remind the subject/parent to continue completion 
and return of the diaries to the study site in the prepaid envelopes. 
2. Safety Check:  Query for adverse events and other issues 
 
Visit 3 (3-4 months after baseline, approximately 1 hour)  
1. Standing coronal full-spine radiographs out of the brace and measurement of the Cobb 
angle 
2. Download of temperature monitor data from GSM brace 
3. Collection of GSM Brace Diary 
4. Completion of the Brace Questionnaire and the Italian Spine Youth Quality of Life 
(ISYQOL) questionnaire 
5. Completion of GSM App Feedback Questionnaire (optional)  
6. Safety Check:  Query for adverse events and other issues 
7. Performance Check:   
a. If the Cobb angle measures no more than 10 degrees greater than that obtained 
from the subject’s most recent out of brace radiograph (prior to enrollment), we 
will conclude the curve is stable or has progressed within the expected limit.  If 
not, the subject will resume use of the TLSO. 
b. If curve stabilization is seen, subjects may opt to continue the GSM brace or 
resume use of their TLSO based on subject and parent preferences.   
 
Ongoing Evaluations after Visit 3 (following the standard-of-care until GSM brace is 
discontinued) 
For subjects continuing to use the GSM brace after Visit 3:  Subject clinical care and evaluations 
(x-rays, clinical exams) after Visit 3 will be limited to that typically performed as the standard of 
care (SOC).  The exception to the SOC will be the administration of the BrQ and ISYQOL at the 
end of treatment, ongoing monitoring and recording of AE’s discovered during routine clinic 
visits or other communications, and temperature monitoring (at sites where this is not typically 
SOC).  Clinical and radiographic data from these visits will be collected for study purposes 
(height, weight, onset of menses, Cobb angle(s), kyphosis, lordosis, coronal and sagittal 
balance, apical vertebral rotation, in-brace Cobb angle(s), and skeletal maturity indicators) as 
available.  
 
GSM brace treatment will be discontinued using individualized SOC parameters such as Cobb 
angle and skeletal maturity indicators, at which time the subject will exit the study.   

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Exit From Study 
Subjects will exit the study upon occurrence of the following events 
1.  Visit 2.  GSM in-brace Cobb is >10° more than the TLSO in-brace Cobb 
2.  Subject not wearing or tolerating GSM brace (per temperature monitor reading 2 
weeks after baseline, or at any time during study period) 
3.  Visit 3.  GSM out-of-brace Cobb indicates curve progression  
4.  GSM brace is discontinued using standard of care criteria 
 
Additional Information on Assessments 
Radiographs and Assessments:  When available, radiographs will be obtained using the EOS® 
Imaging system Micro Dose protocol.  The EOS® system provides low dose, full body, stereo-
radiographic images of patients in a functional position.  It is a bi-planar device using two 
perpendicular fan beams of X-rays and proprietary detectors that travel vertically while 
scanning the patient. In a few seconds, the EOS® exam produces two simultaneous frontal and 
lateral, low dose images of the whole body or an anatomical segment. The Micro Dose option 
for pediatric follow up exams further reduces the radiation exposure.  http://www.eos-
imaging.com/us/professionals/eos/eos.  
Participating sites who do not have access to the EOS® Imaging system Micro Dose protocol are 
allowed to use their existing equipment.  However, they are responsible for calculating the 
amount of research-related radiation and the potential risks, to include this information in 
IRB/human subjects research application materials, and to relate this information to the subject 
via the informed consent document as required by the IRB or equivalent review board.   
 
In addition to the Cobb angle, other components of the deformity will be measured, including 
kyphosis, lordosis, apical vertebral rotation, and coronal and sagittal balance. 
Spiropet 
Vital capacity will be estimated using the Spiropet portable spirometer.  Subjects will be 
instructed to inhale as deeply as possible and to then exhale completely over 5 to 6 seconds 
through the spirometer.  This will be repeated 2 times, with a minimum of 30 seconds in 
between trials.  Disposable mouthpieces are used to prevent contamination across subjects.  
https://www.fitnessmart.com/products/spiro-pet-small-dry-spirometer-model-
64450?variant=29708592263 
 
Temperature Monitors to Estimate Brace Adherence 
Participating sites are encouraged to use their standard-of-care brace temperature 
monitors/loggers.  If the site has not been using a monitor to estimate brace wear, the sponsor 
will provide iButtons and the required hardware/software.   

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The iButton™ is a commercially available electronic device which records and stores time, date 
and temperature readings.  The logger will be set to record date, time and temperature every 
15 minutes.  The temperature range at which the brace is assumed to on will be set at 82.4°F 
and 110°F.  Validation of the accelerometer data as an estimate of the number of hours per day 
that the subjects are wearing the brace will be done via comparison with data from a 
temperature logger. The reliability and validity of iButton™ data for estimating wear time has 
been demonstrated in several published reports. 27-29 (iButton™ DS1922L” 
https://www.thermochron.com/product/ds1921g-thermochron/?gclid=EAIaIQobChMI5t-
G1K6G3QIVRMDICh1A2gDSEAAYASAAEgL1YvD_BwE (Maxim Integrated Products, Inc.; 120 San 
Gabriel Drive, Sunnyvale, CA 94086).   
 
Questionnaires 
The Brace Questionnaire (BrQ, 34 items 30) and the Italian Spine Youth Quality of Life 
Questionnaire (ISYQOL, 20 items 31) are validated measures of health-related quality of life in 
patients being treated for spinal deformities.  An item directly asking the subject how much 
they like their brace was added for this study.  The GSM Brace Diary was created specifically for 
this study based on the Scoliosis Compliance Questionnaire. 17 The diary lists several daily 
activities (e.g. time at home, time at school, sports, being with friends, walking, bending, taking 
brace on and off) and asks the subject to rate how challenging they were that day on a 5-point 
Smiley Face scale from laughing to crying.  The diary also includes questions about pain and 
discomfort in the brace, and a free text area for the subject to record any other comments they 
have related to brace wear.   
 
GSM Brace Mobile App (optional) 
Subjects will be able to opt in or out of use of the app.  The app was developed by GSM 
specifically for this pilot and is available free-of-charge to interested subjects.  The app is 
available for IOS and Android via the App Store and Play Store.  Security functions have been 
built into the app to maintain confidentiality, integrity and availability as referenced by the NIST 
cybersecurity framework, HIPAA and the FDA.  Updates are validated through Apple and Google 
stores.  The app is not intended for use in the diagnosis of disease or other conditions, or in the 
cure, mitigation or treatment or prevention of disease and is therefore not considered a 
medical device and is outside of FDA purview. According to FDA guidance, the app poses 
minimal risk to the user as it is solely intended to help users self-manage their disease (track 
brace wear time) and does not provide any specific treatment suggestions.   
 
The mobile app connects to the sensor in the brace and downloads the data.  Once the data are 
downloaded, the app uploads the data to a cloud-based server.  The mobile app queries the 
server for the wear-time estimates and displays them graphically on the mobile device.  All data 

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transfers (brace to app, app to cloud, cloud to app) are encrypted, as are the data stored on the 
server.  The server keeps a record of the transfer details for an audit trail, including the 
following:  Serial number of the sensor in the brace, unique user ID, battery level in the sensor, 
sensor firmware version, mobile app version, records transferred and time of transfer.  The 
permissions required by the app include:  Location, USB storage, and network access, Bluetooth 
settings and Bluetooth pairing.  The app’s Privacy Policy (as of July 2, 2019) discusses sharing 
data from the app with health care professionals via an interactive platform if permission is 
granted by the user and the provider.  This function is not available at this time, and there are 
no plans to share app data with anyone but the subject during this pilot study.  Directions for 
accessing and using the app will be provided to the families (GSM App Instructions, attached).  
The server (and the software residing on the server) are managed by Mindset Medical.  Green 
Sun Medical has a Business Associate Agreement with Mindset Medical that satisfies HIPAA 
requirements.   
 
5.1.2 BRACE CUSTOMIZATION, DOSING AND ADMINISTRATION 
The GSM braces will be provided directly to the research team by the company at no cost.  Each 
GSM brace will be custom-fabricated via computer-assisted design using the 3D torso scans and 
a treatment plan (e.g. placement of corrective forces) devised by the treating orthotist as 
inputs.  The brace components are then assembled.  Once assembled, the GSM brace will be fit 
to the subject by representatives of the manufacturer and in consultation with the treating 
orthotist.   
 
The GSM brace will be prescribed for the same number of hours per day as was the TLSO 
(generally 18-22 hours per day, individualized based on patient characteristics).  Subjects and 
the family will be shown how to don and doff the brace, how to remove the temperature 
monitor, and how to exchange and recharge the battery in the GSM sensor board.   
 
5.2 RISK/BENEFIT ASSESSMENT 
5.2.1 KNOWN POTENTIAL RISKS 
GSM brace:  The GSM brace is a non-significant risk device.  The FDA defines a significant risk 
device under 21 CFR 812.3(m) as: 
 
1) Is intended as an implant and presents a potential for serious risk to the health, safety, 
or welfare of a subject;  
2) Is purported or represented to be for use supporting or sustaining human life and 
presents a potential for serious risk to the health, safety, or welfare of a subject;  

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3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating 
disease, or otherwise preventing impairment of human health and presents a potential 
for serious risk to the health, safety, or welfare of a subject; or  
4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a 
subject 
 
A non-significant risk device is any device that does not meet those criteria. While the device is 
intended for treating the disease of scoliosis, as are TLSO’s, the GSM is not an implant and does 
not meet the criteria defined in 1 and 2 above.  The FDA defines serious risk as potential harm 
to subjects that could be life-threatening, could result in permanent impairment of a body 
function, or permanent damage to body structure, or could necessitate medical or surgical 
intervention to preclude permanent impairment of a body function or permanent damage to 
body structure. There are no risks associated with this device that could be categorized as 
serious.  
 
The GSM Dynamic Orthosis is a brace worn externally over the torso of a patient. It has been 
designed to provide forces of similar magnitude to current standard-of-care braces.  
 
There are no known or suspected risks directly associated with the GSM brace.  The 
performance and safety checks built into the protocol should theoretically insure that use of 
the GSM brace does not adversely affect the longer-term outcome relative to what was 
anticipated if only the TLSO was used.  However, it is difficult to predict the results of a TLSO for 
any individual patient and we cannot know with any certainty, given the design of this pilot 
study, whether or not the GSM brace influences the risk of a successful outcome. 
 
Rare adverse events have been reported related to the use of TLSOs. 7 Most events involve loss 
of skin integrity (rash, bruise, irritation) due to pressure from the brace on the skin.  Some 
change in the skin is expected in response to the corrective forces, but loss of integrity should 
not occur.  The risk of these events will be mitigated by careful fitting of the GSM brace and by 
advising subjects to immediately report any areas of discomfort so the brace can be adjusted.  
In addition, patients using rigid TLSOs have reported issues with body image and self-esteem, 
depression and anxiety, although it is not clear that these concerns are directly related to brace 
wear or to the diagnosis itself.  There is no reason to believe that these events or concerns 
would be any more frequent or severe during the use of the GSM brace, and may be less 
frequent. Subjects will be followed closely via phone calls every 2 weeks and queried about 
concerns/events related to brace wear.   
 

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Study-related Radiation: All subjects will have research-related coronal radiographs while 1) 
wearing their TLSO at baseline, 2) in the GSM brace after 1 week of wear, and 3) out of the 
brace after 3 months of wear.  Three additional in-brace coronal radiographs may be obtained 
at the discretion of the orthotist or investigator in order to maximize the fit, correction, and 
comfort of the brace and/or check the effect of brace modifications.  The total number of 
research-related radiographs will not exceed 6.   
 
Other than ionizing radiation, here are no valid and reliable methods currently available to 
directly assess the spine’s response to a scoliosis brace.  The frequency of radiographs during 
brace treatment for AIS varies, but in general, radiographs are obtained prior to initiation of a 
brace, in the brace anywhere from the day the brace is fit to 6 months afterward, and then 
every 4-6 months until criteria for brace discontinuation is met.  Since subjects will enter this 
study at different times during their treatment, we cannot anticipate which, if any, of the 
radiographs obtained in this study should be considered standard of care. Therefore, all 
radiographs obtained between consent and Visit 3 will be considered study-related.   
 
A urine pregnancy test will be administered to all subjects who are of child-bearing potential.  If 
the test is positive, the subject will exit the study.   
 
When available, participating sites should obtain the study radiographs using the EOS® Micro 
Dose protocol.  Use of this protocol results in significantly decreased radiation exposure to the 
subject relative to standard digital radiography.  Comparisons of the EOS® Micro Dose protocol 
with digital radiography indicate a significant decrease in radiation exposure (0.02 mGy vs. 1.66 
mGy; 32 2.6µSV vs. 67.5 µSV 33) for a full spine coronal plane radiograph.  Attached 
correspondence from the University of Iowa Medical Radiation Protection Committee (advisory 
to the University of Iowa Institutional Review Board) estimates 1 coronal full spine radiograph 
using the EOS® Micro Dose protocol would expose the subject to an effective dose equivalent 
of 0.25 mrem, which is about equal to the average environmental radiation everyone 
experiences in 1 day.  The maximum study-related effective dose equivalent will total 
approximately 3 mrem of radiation.  The maximum total exposure for all study-related radiation 
is approximately equal to the amount of radiation everyone experiences in 3 days.   
 
**Participating sites who are not using the EOS® Micro Dose protocol will be responsible for 
calculating the amount of research-related radiation and the potential risks, to include this 
information in IRB/human subjects research application materials, and to relate this 
information to the subject via the informed consent document as required by the IRB or 
equivalent review board.** 
 

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Spirometry: There are no risks associated with use of the Spiropet spirometer.  Subjects may 
stop the testing at any time if they feel uncomfortable.    
 
Privacy and confidentiality:  The risk to privacy will be minimized by performance of study 
procedures in a private area whenever possible.  Only data necessary to address the study aims 
will be collected.  Subjects will be informed they can skip any questions they do not feel 
comfortable answering.  Risk to confidentiality will be minimized by using study ID’s in lieu of 
other identifiers to identify subject data.  ID’s will be assigned in order of enrollment within site 
(e.g. 2-digit site ID_01, 2-digit site ID _02, etc.), and their link to the subject’s identity will be 
maintained in a file separate from study data.  Other risks to confidentiality will be minimized 
by storage of paper forms in a locked office and electronic data in a password-protected file in a 
password-protected computer.  Only data conforming to the definition of a HIPAA limited 
dataset will be transmitted over the Internet.  Entries in the screening log will be deleted as 
soon as a decision about participation is made, or at the close of the study if the patient has not 
yet made a decision.   
 
Subjects opting to install and use the GSM Brace Mobile App may risk loss of confidentiality if 
their mobile device is lost, stolen, borrowed or if the subject accesses the app in view of others.  
The App or Play stores may track download and installation.  Loss of confidentiality is minimized 
by using non-identifying information to register; subjects will use their Study ID and City in lieu 
of their name, DOB will be entered as January 1, 2019 and a non-functioning email address 
(Study ID@greensunmedical.com) will be entered.  Additionally, the permissions required by 
the app include:  Location, USB storage, network access, Bluetooth settings and Bluetooth 
pairing, but not other data such as contacts, photos, texts, or email.  Persons other than the 
subject will not be able to access data from the sensors unless they 1) download the app and 2) 
are in close proximity to the subject’s brace (<10 feet) to pair with their device.  All data 
transfers (brace to app, app to cloud, cloud to app) are encrypted, as are the data stored on the 
server.  The server (and the software residing on the server) are managed by Mindset Medical.  
Green Sun Medical has a Business Associate Agreement with Mindset Medical that satisfies 
HIPAA requirements.   
 
Only for subjects enrolled at sites where compensation will come directly from the Sponsor/U 
of Iowa:  If subjects agree to share their name and contact information with the University of 
Iowa for purposes of compensation, this information will be given to Lori Dolan over the phone 
or via fax.   

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5.2.2 KNOWN POTENTIAL BENEFITS 
The subject may benefit from treatment in the GSM brace in terms of curve correction, curve 
stabilization and increased comfort (relative to their standard of care TLSO) while wearing the 
GSM brace, although the potential for longer-term benefit is unknown.   
5.2.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
This study presents minimal risk with the potential for benefit.   
 
5.3 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
It will not be possible to blind the subject or the assessors to the study condition (type of brace) 
due to their unique characteristics (which is also visible in the radiographs).   All radiographic 
measurements will be made by the site PI’s or their delegates and verified by the medical 
advisor (Weinstein).  
 
5.4 COMPLIANCE WITH STUDY INTERVENTION 
The use of the device will be primarily monitored via the temperature monitor data.  A 
secondary aim involves using the temperature monitor data to validate inferences about 
compliance using data from the force and accelerometer sensors built into the GSM brace.   
 
5.5 CONCOMITANT THERAPY 
Subjects will be encouraged to continue with any concomitant therapy and activities during the 
study (e.g. physical therapy, chiropractic, massage, yoga, school, sports). 
 
5.6 COMPENSATION TO SUBJECTS 
Subjects will be compensated $25 after visits 1 and 2, $25 for Visit 3 and then $10 for each 
additional week during the 3 month period (10 weeks), for a possible total compensation of 
$175.  Payment will be issued within 1 month after Visit 2, and within 1 month after the subject 
exits the study.  Payments will be pro-rated according to the number and type of visits 
completed.   
 

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6 STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
6.1 DISCONTINUATION OF STUDY INTERVENTION 
The intervention will be halted by the investigators if: 
1.  Equivalent or improved in-brace correction is not obtained at the Week 1 visit  
2.  If the subject is not able/willing to wear the GSM brace for approximately the same number 
of hours as the TLSO 
3.  Safety concerns are noted by the PI, study staff and/or the medical monitor 
4.  Radiographic evaluation at Visit 3 suggests that the curve is not stable (has progressed more 
than 10 degrees)  
5.  If the parent/subject, investigator or medical monitor feel that continuation of treatment in 
the GSM brace is not in the best interests of the subject.  Ongoing care will be individually 
determined based on standard of care considerations.  
 
Once the GSM brace is discontinued, continued follow-up for safety and efficacy are not 
required.  
 
6.2 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
1.  Participants will be withdrawn from the study in the event of a positive pregnancy test or 
reports of a suspected pregnancy. 
2.  Participants may withdraw voluntarily from the study or discontinue use of the GSM brace at 
any time. Participants who wish to stop wearing the GSM brace will be instructed to notify 
study staff so that treatment can be resumed using the TLSO brace.   
 
Participants will be instructed to contact the study staff (PI, orthotist or coordinator) at any 
time to discuss issues they may be having with the GSM brace or with any other aspect of the 
protocol.  Study staff will attempt to make any modifications to the brace or other aspects of 
the protocol necessary to mitigate these issues and maintain the participant on protocol.   
 
6.3 LOST TO FOLLOW-UP 
Participants will be considered lost to follow-up if they cease to report for study visits and do 
not respond to our attempted contacts.  Staff will contact participants by phone at 2 weeks 
after GSM brace initiation and at least monthly to address questions and issues.  Subjects will 
be queried for any questions or concerns, and for the occurrence of anticipated and 
unanticipated adverse events.  

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Study staff will accommodate the participants' schedule in order to minimize missed study 
visits. In the case of a missed visit, staff will attempt contact via three phone calls and/or emails 
each 1 week apart.  
  
Completion of the questionnaires and diaries will be encouraged but not required.   
7 STUDY ASSESSMENTS AND PROCEDURES 
7.1 PERFORMANCE ASSESSMENTS 
1. Primary performance measures  
1. Visit 2 GSM in-brace Cobb angle compared to that in the TLSO at baseline  
2. Visit 3 out of brace Cobb angle compared to measurements from the most 
recent out of brace radiograph 
3. Average hours of GSM brace wear per day over the 3-month trial period 
(temperature monitor data) 
4. Change in scores on the Brace Questionnaire and the ISYQOL 
2. Secondary measures  
1. Vital capacity and range-of-motion relative to that obtained in the TLSO at Visit 1 
2. Accelerometer data (obtained from an embedded sensor in the GSM brace) as 
an estimate of the average hours of wear per day (to be validated by comparison 
with temperature monitor data) 
 
7.2 SAFETY ASSESSMENTS:  ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
Safety will be monitored continuously during the trial  
7.2.1 DEFINITION OF ADVERSE EVENTS (AE) 
The following AE’s are anticipated and related or possibly related to brace wear or to the 
diagnosis of AIS: 
• Skin Issues (on the trunk, shoulders or any other area in contact with the brace):  
bruising, lacerations, ulcers, pressure sores, rash.  Most skin issues are classified as mild 
and can be alleviated by minor adjustments to the brace. 
• Back pain 
• Anxiety 
• Problems sleeping 
• Shortness of breath 
• Altered body image or self-esteem 

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7.2.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) 
Death 
Life-threatening conditions 
Hospitalization 
Disability 
A condition requiring intervention to prevent permanent impairment/damage 
7.3 CLASSIFICATION OF AN ADVERSE EVENT 
7.3.1 SEVERITY OF EVENT 
Mild = not requiring treatment 
Moderate = resolved with treatment 
Severe = unable to carry on normal activities and required professional medical attention 
7.3.2 RELATIONSHIP TO STUDY INTERVENTION 
Unrelated 
Possibly related 
Related 
7.3.3.3 EXPECTEDNESS 
Unexpected 
Expected (described in the protocol and/or Investigator’s Brochure) 
7.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP  
AE's will be solicited at each study visit, during the scheduled phone contacts and as often as 
daily via subject report on the questionnaires 
Unsolicited AE's may be identified via observations and general discussions with the subject 
and/or parent at the study visits 
7.3.5 ADVERSE EVENT REPORTING 
Events will be recorded on the Adverse Event case report form as they are identified 
All events will be reported to the sponsor upon identification 
All unanticipated events will be reported to the IRB on continuing review applications or close 
of study (or according to local IRB policy).   
Adverse event forms will be sent to the medical monitor every 2 weeks during the study, who 
will then summarize the AE’s in a report to the sponsor and IRB.   

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7.3.6 SERIOUS ADVERSE EVENT REPORTING 
All unanticipated serious adverse events will be reported within 48 hours of identification to 
the sponsor, medical monitor and the IRB (or as required using local standards) 
7.3.7 REPORTING EVENTS TO PARTICIPANTS 
All moderate or severe, possibly related or related events will be reported to subjects who are 
currently wearing the GSM brace via a phone call from the PI within 48 hours of identification 
8 STATISTICAL CONSIDERATIONS 
8.1 SAMPLE SIZE DETERMINATION 
Study-wide, recruitment will continue until at least 10 but no more than 30 subjects have 
completed 3 months in the GSM brace.  The final sample size will depend on an ongoing 
examination of the results, patient comments, input from medical monitor and the discretion of 
the sponsor.  Therefore, if a subject exits the study prior to that point, another subject will be 
enrolled.  The sample size is appropriate for initial field testing of this device and no sample size 
calculations were conducted.   
 
8.4 STATISTICAL ANALYSES 
This is a pilot study and no formal hypothesis testing will be done. 
Descriptive statistics of selected variables will be calculated.  
Primary Aims 
1. Safety of the GSM brace:  Summary of all adverse events; number and nature of 
adjustments made to the GSM brace  
2. Performance of the GSM brace:  
a. Difference between in-brace Cobb angle measurements obtained in each brace 
b. Difference in out of brace Cobb angles (pre- and 3 months post-GSM brace) 
c. Average hours of wear per day relative to the prescription and to historical wear 
data (from chart and temperature monitor) 
d. Change in BrQ and ISYQOL scores baseline to 3-month visit; summary of GSM 
acceptability during various activities and qualitative analysis of free text entries 
recorded in GSM Brace Diary 
 
Secondary Aims 
1. Difference in range-of-motion testing between TLSO and GSM brace 
2. Difference in vital capacity testing between TLSO and GSM brace 

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3. Correlation of accelerometer data and temperature monitor data; development and 
testing of an algorithm to convert accelerometer data to an estimate of the average 
hours of wear per day. 
 
 
 

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Benish BM, Smith KJ, Schwartz MH. Validation of a miniature thermochron for 
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Appendix 1. 
Green Sun Medical Pressure-Sensor Equipped Pad Clinical Validation  
Substudy of the Pilot Trial Green Sun Medical Dynamic Brace 
Protocol Version 1.0 
14 Jan 2021 
Substudy participation is optional for subjects newly enrolled in the Pilot trial.  Twelve subjects 
at select participating sites will be enrolled.   
1.  BACKGROUND  
Spinal orthotics (braces) are effective in preventing curve progression in patients with 
adolescent idiopathic scoliosis.  Braces work by providing corrective forces to relevant areas of 
the spine, but little is known about the amount of force required, or how forces change during 
activities and over time in response to changes in the shape of the patient’s spine and torso.  
Therefore, it is important to be able to accurately measure these forces over the patient’s 
course of treatment and to understand how much variation is normal, and when variation 
indicates that modifications need to be made to the brace in order to optimize its effectiveness.   
 
The GSM engineering team has developed a smart pad sensor system capable of detecting 
changes in force magnitude and direction, but to date, the sensor system has only been 
evaluated on a test fixture.  The smart pad sensor system of the GSM brace captures force data 
in two ways: interval and conditional. As the name implies, interval sampling captures sensor 
data at a consistent sampling rate. The objective of the conditional sampling is to capture force 
data when the patient and their brace are in a consistent state. This conditional sampling allows 
for a much more meaningful relative measure of brace performance. A conditional sample is 
triggered by the donning of a brace after the brace has been off the patient.  Each interval force 
log includes the following data: 1) timestamp 2) voltage measurements for each of eight sensors 
embedded in the pad, and 3) readings from a 3-axis accelerometer. Each conditional force log 
includes the following data: 1) timestamp, 2) voltage measurements for each of the eight 
sensors, 3) readings from a 3-axis accelerometer, 4) the algorithmically determined force value 
(FV), and 5) the algorithmically determined X-Y coordinates for an equivalent point load.  The 
smart pad system integrates with the standard sensor system placed in all braces and the data 
can either be stored and downloaded by the research team at study visits, or, if the subject is 
participating in the optional GSM Brace Wear Mobile App substudy, the data are uploaded to 
cloud storage when the subject syncs with the sensor. 
 

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2.  OBJECTIVE  
The primary goal of this substudy is to validate the ability of a pressure-sensor equipped pad 
(GSM Smart Pad, smart pad) to accurately and reliably measure static and dynamic forces 
through a combination of lab and field testing using human subjects enrolled in the GSM Pilot 
study.   
 
3.  PROTOCOL 
Evidence for the accuracy and reliability of the force values generated by the smart pad system 
will be inferred via a series of comparisons to known forces and to a gold-standard 
measurement system (Tekscan pressure map/I-Scan™ system) both in the lab and in field 
testing with patient subjects.  Analyses of repeated measures within each smart pad and 
between smart pads will be performed. 
 
Lab Testing Materials and Methods 
Lab Testing Phase 1.  Twelve smart pads will be fabricated for testing and serialized in order to 
track performance over time.  A benchtop test fixture will apply loads of 100N, 110N, 136N 
and 150N maintained for five minutes each with a 0-N dwell of 5 minutes in between loads. 
Loads will be applied in four rotational positions: neutral, 10-degree rotation from neutral, 20-
degree rotation from neutral, and 30-degree rotation from neutral. Each of the 16 unique 
loading scenarios (magnitude x direction) will be run 10 times.  The average force value under 
each of these conditions will be saved and analyzed.  These 12 smart pads will then be used in 
field testing.   
 
Lab Testing Phase 2.  The smart pads removed from the brace at the 30-day follow-up visit will 
undergo repeat testing on the bench test fixture under the same 16 loading conditions.   
 
Field Testing Materials and Methods 
Subjects 
Twelve subjects will be recruited from multiple sites to participate in the field testing.  We will 
draw from the pool of patients who have consented to participate in the GSM Brace Pilot 
study.  They will be told that participation in both studies is completely voluntary.  Enrolled 
subjects may choose to stop participating at any time.   
 
Visits and Procedures 
Subjects in the substudy will undergo all procedures/assessments as those in the Pilot study.  
Participation in the substudy will last for approximately 1 month.  One additional study visit 
will be required at approximately 1 month after Baseline.  Otherwise, substudy procedures will 

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occur coincident with the Baseline, 1-week and 3-month follow-up visits in the Pilot protocol.   
 
Baseline Visit.  Subjects in the substudy will receive a GSM brace that includes one of the 
serialized smart pads tested during Lab Testing Phase I.  No additional procedures or 
assessments for the substudy occur at this visit.   
 
Visit 2 (1-2 weeks after Baseline).  Substudy procedures will add approximately 1 to 1.5 hours 
to the total duration of this study visit.  The following procedures/assessments will take place 
in addition to the Pilot study activities (in-brace x-ray, safety check): 
1.  Calibration of the pressure map.  The Tekscan pressure map is a very thin, flexible 
material embedded with force sensors to measure the magnitude and distribution of force 
exerted over an area.  This map must be calibrated prior to use.  To calibrate the map, the 
orthotist and research team will establish the area where the brace’s thoracic pad would 
contact the subject’s torso.  The pressure map is then placed against the subject’s torso with the 
smart pad (not yet attached to the brace) is centered over the map.  A handheld force 
gauge (Mark 10 Series 4) is pressed on the smart pad to successively apply 80-N and 120-N 
forces to the patient for a period of less than 1 minute each.  These known forces are then 
used by the I-Scan™ system to calibrate the pressure map for subsequent readings. 
2.  The smart pad is then placed in the GSM brace.  The subject will don (put on) the brace, 
and the research team will place the pressure map between the subject’s torso and the 
smart pad.  The orthotist will assist the subject to adjust the strap tension and position of 
the brace.  The subject is then asked to stand for 5 minutes in a normal posture with 
minimal spinal flexion or extension.   
3.  The subject will then be asked to doff (remove) the brace for 5 minutes. 
4.  Steps 2-3 are repeated for a total of four don-doff trials.  During these trials, both the 
pressure map and the smart pad will capture force data. The smart pad will capture interval 
data once per minute; the don and doff trials will trigger the algorithm to capture one 
conditional sample for each trial.   
 
Interim Between Visit 2 and the 1-Month Visit.  The subject will continue to wear the GSM brace 
with the smart pad for a period of approximately 30 days. During this time, the smart pad will 
continuously capture data. These data will stored on the device and transmitted to the cloud 
when the device is paired with the GSM mobile app (if the subject is also participating in the 
optional GSM Brace Wear Mobile App study). If the subject does not pair with the device during 
this period, the data will be retrieved by the research team at the 1-month visit. 
 
1-Month Visit (substudy subjects only).  The smart pad will be removed from the subject’s brace 
for Lab Testing Phase II and a replacement smart pad will be installed.  The same set of 

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procedures completed during Visit 2 will be repeated (calibration of the Tekscan pressure map 
system via application of known 80-N and 120-n forces, data collection during donning and 
doffing).  This visit will last approximately 1-1.5 hours.   
4. RISKS 
Subjects in the substudy should experience no additional risks beyond those encountered 
during participation in the Pilot study.  The same safety and performance checks will be 
completed (e.g. if a subject does not have adequate correction in the GSM brace, or is unable 
to wear the brace the recommended number of hours, then the subject will exit the Pilot and 
the Validation substudy).   
Tekscan pressure maps and the sensors embedded in the smart pad have been used in both 
lab and field tests without safety concerns.  Applying forces of 80-N and 120-N should not 
cause the subject any discomfort as similar forces are applied by a typical scoliosis brace 
during normal wear.  However, if a subject complains of discomfort, the team will withdraw 
the pressure immediately.   
The data offloaded from the Tekscan pressure map/I-Scan™ system and the smart pad will be 
tagged only with the subject’s study ID but no direct identifiers.  These data will be treated 
with the same confidentiality measures as data from the Pilot study.   
5.  BENEFITS 
The subjects in the substudy will experience no direct benefit from participating.  However, we 
hope their participation will lead to a sensor pad-based pressure monitoring system that can 
be used to optimize scoliosis brace treatment in the future.   
6.  COSTS 
Subjects in the substudy may incur uncompensated costs associated with the longer Visit 1 
duration and the additional 1-month visit.  These costs are in addition to those already 
incurred by participation in the Pilot study (e.g. travel, parking, loss of work/school time). 
7.  COMPENSATION 
Subjects will be compensated $50 for their participation in the 1-month substudy visit.  
8.  SAMPLE SIZE CALCULATIONS AND STATISTICAL ANALYSIS 
No formal sample size/power calculations were done to arrive at the sample of 12 subjects.  
Given the large number of repeated measures data to be collected, and given the results from 
earlier bench work, we anticipate data from 12 subjects are adequate to attain the precision 
necessary to make informed decisions about the accuracy and reliability of the sensors in this 
study.   

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Lab Testing Analysis:  The distribution of force values generated by each smart pad unit under 
each scenario will be characterized by the mean, standard deviation and coefficient of 
variation (CV, ((mean/s.d)*100)).   
1.  The inter- and intra-unit reliability of the force measures will be inferred by testing the 
variation of the means and the CsV within and between the 12 smart pad units under each 
of the 16 scenarios using the R package cvequality (Version 0.1.3; Marwick and 
Krishnamoorthy 2019) and repeated measures ANOVA. The quality control standard will 
be set at a CV of 5% or less. Units that demonstrate CsV >5% will not be used in the field 
testing.  
2.  Reproducibility/durability of smart pad measurements will be assessed using repeated 
measures ANOVA comparing Test 1 to Test 2 measures.   
 
Field Testing Analysis  
1.  The force values measured by the I-Scan system and the smart pad during the Baseline 
and 1-Month visits will be compared using repeated measures analysis of variance.   
2.  The means and CsV of the force values over the 30-day wear period will be evaluated, looking for 
changes over time, and within and between Active and Rest periods using repeated measures 
ANOVA. 
3.  A regression model will be derived to convert each 24-hour set of force values to an 
estimate of the number of hours the brace was worn, using the temperature monitor 
output as the gold standard.  The predictive accuracy of the smart pad model will be 
assessed using calibration plots and other error estimates.   
 

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Appendix 2. 
Protocol Amendment Version 1.3/1.4 to Version 2.0 
Summary of Changes 
Version Date 14 Jan 2021 
Summary of Major Revisions Made:  
 
Adding Appendix 1.0  Optional Substudy Protocol “GSM Pressure-Sensor Equipped Pad Clinical 
Validation”  
 
 
Version Number 
Version Date 
Current Approved Protocol 
1.3/4 
27 Aug 2019 
Amended Protocol 
2.0 
14 Jan 2021 
 
1. Section 1.3 Green Sun Medical Dynamic (GSM) Brace  
New Text: Green Sun Medical Dynamic (GSM) Brace (also known as the Green Sun Medical Whisper 
Brace™)  
2. 5.1.2 Study Procedures  
Old Text: All study-related radiographs will be obtained using the EOS® Imaging system 
Micro Dose protocol.  
New Text: All study-related radiographs will be obtained using the EOS® Imaging system 
Micro Dose protocol (when available). If an EOS system is not available, please see 
Additional Information on Assessments.  Radiographs and Assessments, and 5.2.1 Risks 
for further information).   
Rationale for Change: The original intent was to only enroll subjects at sites with access to EOS® 
Imaging systems.  The trial has since been opened up to sites who use other digital imaging 
systems.   
3. 5.1.2. Study Procedures  
Old Text: Orthotimer   
The Orthotimer is a commercially available electronic device which records and stores 
time, date and temperature readings.  Software converts the readings to estimates of 
brace wear time.  These devices have been used at the National Scoliosis Center for 
several years.  The Orthotimer results will be used to determine the average daily hours 
of wear in the GSM brace and to validate estimates of wear time using data from the 
accelerometer built into the GSM brace.  http://www.orthotimer.com/en/ 
 

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38 of 38 
 
 
New Text: Deleted description of the Orthotimer.    
Rationale for Change: No sites in the study are using the Orthotimer.  Text changed to 
allow sites to use their standard-of-care compliance monitors, or to be provided with 
iButtons by the sponsor.   
4. Appendix 1.  Green Sun Medical Pressure-Sensor Equipped Pad Clinical Validation  
Rationale for Change: Appended Protocol Version 1.0 14 Jan 2021 for the optional substudy.   
 
 
5. Administrative changes: Minor changes involving grammar, wordsmithing, punctuation, 
and other editorial changes have been made throughout the document. All are clearly 
identified in the track-changes version of the amendment.