Idiopathic ScoliosisRESILIENTNCT07574632
A Study to Evaluate a New Semi-rigid Brace, the RESILIENT Brace by Thinks Works, as a Way to Limit Curve Worsening in Kids With Idiopathic Scoliosis.
A study testing The RESILIENT scoliosis brace system in people with Idiopathic Scoliosis, run by Thinks Works, PBC at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if the RESILIENT Scoliosis Brace System works to treat children with idiopathic scoliosis. It will also learn about the safety, comfort, and usability of the brace. Read more about this study
- Who is it for?
- Ages 9 to 16 years
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- The RESILIENT scoliosis brace system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2026to Aug 2029
- 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 9 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Idiopathic Scoliosis (IS)
- Age of 9 - 16 years when brace treatment is prescribed
- Primary right apex main thoracic scoliosis curve with an apex of T6 or lower
- Cobb angle, as measured on a standing PA spine x-ray, 20 degrees or larger and 30 degrees or less, obtained no more than 6 weeks prior to trial enrollment.
- Sanders Skeletal Maturity Score of 1-5
- No prior brace treatment or surgery for scoliosis
- Patient \& guardian select the RESILIENT brace for treatment
- The guardian must confirm that there is cellular connectivity at the place(s) where the patient lives
Who cannot join
- Scoliosis other than idiopathic scoliosis: e.g. Neuromuscular, Congenital, or Syndrome Related
- Age less than 9 years or older than 16 years
- Sanders Skeletal Maturity Score of 6 or greater
- Primary Left apex thoracic scoliosis
- Primary lumbar scoliosis
- Primary Right Thoracic curve with an apex above T6
Show all 10Show fewer
- Inability to remove and apply the brace independently
- Inability to respond to written and verbal questions
- Patient \& Guardian select traditional TLSO for treatment
- Guardian confirms there is no cellular connectivity at the place(s) where the patient lives
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ryan C. Murdock, MD, MS. CEO of Thinks Works. contact
United States1 site, 1 recruiting
- Recruiting
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
Petya Yorgova Clinical Research Coordinator Sr, Department of Orthopedics, 302-651-5920, Petya.Yorgova@nemours.org
About this study
Official title: The RESILIENT Scoliosis Brace System Clinical Trial (RESILIENT)
The goal of this clinical trial is to learn if the RESILIENT Scoliosis Brace System works to treat children with idiopathic scoliosis. It will also learn about the safety, comfort, and usability of the brace. The main questions it aims to answer are:
- Can the RESILIENT brace prevent the spinal curve from progressing beyond 35 degrees during growth?
- How much does the brace correct the curve when it is first worn (in-brace correction)?
- How well do participants follow the prescribed brace wear time and force levels?
- How does wearing the brace affect quality of life and daily activities?
Read more
Researchers will study a single group of participants using the RESILIENT brace and evaluate outcomes over time using standard clinical assessments, including X-rays and patient-reported questionnaires.
Participants will:
- Be fitted with the RESILIENT brace and instructed on how to use it
- Wear the brace daily according to physician recommendations throughout their growth period
- Attend clinic visits at approximately 4-6 weeks after starting treatment and then about every 6 months for follow-up evaluations
- Undergo standard-of-care spine X-rays to monitor curve progression
- Complete questionnaires about their quality of life and experience with the brace
- Have brace wear time and applied forces monitored using sensors embedded in the device
Participants will be followed from the start of brace treatment until they are done growing and have completed treatment.
- Conditions
- Idiopathic Scoliosis
- Being tested
- The RESILIENT scoliosis brace system
- Keywords
- scoliosis, brace, idiopathic scoliosis, flexible brace, semi-rigid brace, adolescent idiopathic scoliosis, AIS, IS
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The RESILIENT scoliosis brace systemDevice
Also called The RESILIENT brace
The RESILIENT brace is a novel semi-rigid (flexible), concealable, adjustable and modular brace with embedded sensors measuring force and wear time.
| Study group | Role | What they receive |
|---|---|---|
| RESILIENT Scoliosis Brace System | Experimental | Patients will be fitted with a novel semi-rigid, low-profile, adjustable, and modular scoliosis brace with embedded sensors measuring force and wear time. Receives: Device: The RESILIENT scoliosis brace system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success Based on Curve Progression at Skeletal Maturity
Treatment success is defined as a right main thoracic Cobb angle less than or equal to 35 degrees at skeletal maturity. Treatment failure is defined as progression of the curve to greater than 35 degrees at any time during the treatment period.
Cobb angle measurements are obtained from standing posteroanterior spine radiographs and assessed by independent reviewers blinded to patient information.
Skeletal maturity is defined as a Sanders Skeletal Maturity Score of ≥7B, absence of longitudinal height increase over the preceding 6 months, and, for female participants, at least 18 months post-menarche.
Measured: From baseline to skeletal maturity (approximately up to 36 months)
Secondary outcomes (6)
In-Brace Curve Correction at Initial Follow-up
Percent reduction in the primary right main thoracic Cobb angle on standing in-brace posteroanterior spine radiographs obtained at the 4- to 6-week follow-up visit, compared with baseline standing radiographs obtained prior to brace treatment.
Measured: 4 to 6 weeks
Measurement of brace use compliance as a percentage of prescribed use.
Percent compliance with prescribed daily brace wear time and prescribed apex strap force, as measured by force sensors integrated into the brace and recorded in the monitoring system.
Measured: From brace initiation through completion of treatment, approximately up to 36 months
Change in Curve Magnitude Following Completion of Brace Treatment
Percent change in the primary right main thoracic Cobb angle from baseline to the final follow-up radiograph obtained after brace discontinuation.
Measured: From baseline to 4 to 6 months after brace discontinuation
PROMIS Pediatric Quality of Life Scores
Patient-reported outcomes measured using PROMIS pediatric modules. Theses are rated using a numeric rating scale. Physical function-mobility is scored 1-4 with 4 being the best outcome score. Peer relationships is scored 1-5 with 5 being the best outcome score. Depressive symptoms is scored 1-5 with 1 being the best outcome score.
Measured: Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months
Scoliosis Research Society-22 (SRS-22) Score
Patient-reported scoliosis-related quality of life measured using the SRS-22 questionnaire.
Measured: Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months
Patient and Parent Clinical Trial Completion Exit Survey
When the patient has completed the clinical trial the patient and parent(s)/guardians will be given a survey to assess their overall experience with the brace treatment. It has questions with numerical rating scores from 1-5 with 1 being the best outcome score and questions with descriptive ratings from very positive-very negative, strongly agree-strongly disagree, very likely-very unlikely, extremely willing-not willing.
Measured: This survey will be given to patients at the completion of their participation in the study, approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start28 May 2026
- Primary completionMay 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thinks Works, PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Setting Scoliosis Straight Foundation, Nemours Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Suken A. Shah, MD, Principal investigator, Nemours Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574632
- Sponsor's protocol ID
- RESILIENT2026
- Acronym
- RESILIENT
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RESILIENT Scoliosis Brace System Clinical Trial (RESILIENT)
- ClinicalTrials.gov ID
- NCT07574632
- Acronym / sponsor ID
- RESILIENT / RESILIENT2026
- Conditions
- Idiopathic Scoliosis
- Keywords
- scoliosis, brace, idiopathic scoliosis, flexible brace, semi-rigid brace, adolescent idiopathic scoliosis, AIS, IS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Thinks Works, PBCIndustry (pharma, biotech, devices)
- Collaborators
- Setting Scoliosis Straight Foundation, Nemours Children's Hospital
- Study start
- 28 May 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 8 May 2026 (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 goal of this clinical trial is to learn if the RESILIENT Scoliosis Brace System works to treat children with idiopathic scoliosis. It will also learn about the safety, comfort, and usability of the brace. The main questions it aims to answer are:
- Can the RESILIENT brace prevent the spinal curve from progressing beyond 35 degrees during growth?
- How much does the brace correct the curve when it is first worn (in-brace correction)?
- How well do participants follow the prescribed brace wear time and force levels?
- How does wearing the brace affect quality of life and daily activities?
Researchers will study a single group of participants using the RESILIENT brace and evaluate outcomes over time using standard clinical assessments, including X-rays and patient-reported questionnaires.
Participants will:
- Be fitted with the RESILIENT brace and instructed on how to use it
- Wear the brace daily according to physician recommendations throughout their growth period
- Attend clinic visits at approximately 4-6 weeks after starting treatment and then about every 6 months for follow-up evaluations
- Undergo standard-of-care spine X-rays to monitor curve progression
- Complete questionnaires about their quality of life and experience with the brace
- Have brace wear time and applied forces monitored using sensors embedded in the device
Participants will be followed from the start of brace treatment until they are done growing and have completed treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RESILIENT Scoliosis Brace System | Experimental | Device: The RESILIENT scoliosis brace systemPatients will be fitted with a novel semi-rigid, low-profile, adjustable, and modular scoliosis brace with embedded sensors measuring force and wear time. |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Diagnosis of Idiopathic Scoliosis (IS)
- Age of 9 - 16 years when brace treatment is prescribed
- Primary right apex main thoracic scoliosis curve with an apex of T6 or lower
- Cobb angle, as measured on a standing PA spine x-ray, 20 degrees or larger and 30 degrees or less, obtained no more than 6 weeks prior to trial enrollment.
- Sanders Skeletal Maturity Score of 1-5
Key exclusion criteria (10 listed)
- Scoliosis other than idiopathic scoliosis: e.g. Neuromuscular, Congenital, or Syndrome Related
- Age less than 9 years or older than 16 years
- Sanders Skeletal Maturity Score of 6 or greater
- Primary Left apex thoracic scoliosis
- Primary lumbar scoliosis
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 |
|---|---|---|
| The RESILIENT scoliosis brace systemAlso: The RESILIENT braceThe RESILIENT brace is a novel semi-rigid (flexible), concealable, adjustable and modular brace with embedded sensors measuring force and wear time. | Device | RESILIENT Scoliosis Brace System |
Primary outcome
Treatment Success Based on Curve Progression at Skeletal Maturity
Time frame: From baseline to skeletal maturity (approximately up to 36 months)
Treatment success is defined as a right main thoracic Cobb angle less than or equal to 35 degrees at skeletal maturity. Treatment failure is defined as progression of the curve to greater than 35 degrees at any time during the treatment period. Cobb angle measurements are obtained from standing posteroanterior spine radiographs and assessed by independent reviewers blinded to patient information. Skeletal maturity is defined as a Sanders Skeletal Maturity Score of ≥7B, absence of longitudinal height increase over the preceding 6 months, and, for female participants, at least 18 months post-menarche.
6 secondary outcomes
In-Brace Curve Correction at Initial Follow-up
Time frame: 4 to 6 weeks
Measurement of brace use compliance as a percentage of prescribed use.
Time frame: From brace initiation through completion of treatment, approximately up to 36 months
Change in Curve Magnitude Following Completion of Brace Treatment
Time frame: From baseline to 4 to 6 months after brace discontinuation
PROMIS Pediatric Quality of Life Scores
Time frame: Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months
Scoliosis Research Society-22 (SRS-22) Score
Time frame: Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months
Patient and Parent Clinical Trial Completion Exit Survey
Time frame: This survey will be given to patients at the completion of their participation in the study, approximately 24 months.
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 1 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Scoliosis
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Active, not recruitingObservational study
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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.
Ryan C. Murdock, MD, MS. CEO of Thinks Works. contact
Suken A. Shah, MD principal investigator
Nemours Hospital for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The RESILIENT scoliosis brace system in people with Idiopathic Scoliosis, run by Thinks Works, PBC 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 8 inclusion and 10 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 1 Jun 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 Avery Patient Experience Liaison, Thinks Works (844-542-7374, hello@thinksworks.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Success Based on Curve Progression at Skeletal Maturity (time frame: From baseline to skeletal maturity (approximately up to 36 months)). 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 1 Jun 2026.