Adolescent Idiopathic Scoliosis (AIS)NCT06314594
Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for AIS
A study testing Routine Guideline-Based Conservative Care and Clinician-Supervised, Platform-Assisted Conservative Management in people with Adolescent Idiopathic Scoliosis (AIS), run by Hangzhou Medical College at 1 site in China.
Trial summary
Adolescent idiopathic scoliosis (AIS) brings substantial physical and psychological burden to affected teenagers, and current conservative follow-up management is fragmented under routine clinical settings. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS)
- What is being tested?
- Routine Guideline-Based Conservative Care and Clinician-Supervised, Platform-Assisted Conservative Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2025to 31 Dec 2026
- 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 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed diagnosis of mild-to-moderate Adolescent Idiopathic Scoliosis (AIS), with a Cobb angle of 10 degrees or greater and less than 45 degrees.
- Age 12 to 16 years, targeting adolescents in the active pubertal growth phase, in whom conservative management (PSSE and bracing) is clinically prioritized.
- Sufficient cognitive and communicative ability to understand the study procedures and use the platform.
- Voluntary participation confirmed by signed guardian informed consent and adolescent participant assent.
- Participants with prior conservative treatment (PSSE or bracing) are eligible provided the treatment regimen has been stable for at least 3 months prior to baseline assessment.
Who cannot join
- Secondary scoliosis caused by identifiable causes such as spinal trauma or prior spinal surgery.
- Clinically significant severe functional impairment of heart, liver, or kidney organ function, defined as grade 3 or higher organ dysfunction according to CTCAE version 5.0.
- Malignant tumours, autoimmune diseases, or other critical systemic illnesses that may interfere with trial outcomes.
- Severe cognitive or psychiatric conditions, including diagnosed intellectual disability, psychotic disorders, or major depressive disorder under active psychiatric intervention, that prevent obtaining valid assent or completing study assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College
Hangzhou, Zhejiang, 311000
Xinyun LI, Doctor, 8618069783240, lxyjasmine2010@163.com
About this study
Official title: Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for Adolescent Idiopathic Scoliosis
Adolescent idiopathic scoliosis (AIS) brings substantial physical and psychological burden to affected teenagers, and current conservative follow-up management is fragmented under routine clinical settings. This single-center, superiority, parallel-group, 1:1 randomized controlled trial with assessor-blinded outcome evaluation will compare a clinician-supervised, platform-supported collaborative care pathway with routine guideline-based conservative care in 76 adolescents with mild-to-moderate AIS. Participants will be assessed at baseline, 4-month (primary endpoint), 8-month, and 12-month follow-up. The primary outcome is the change in Cobb angle from baseline to 4 months. Secondary outcomes include treatment adherence, mental-health status, medical expenditure, participant and guardian satisfaction, and safety outcomes. The primary analysis will follow the intention-to-treat principle. The first participant was enrolled on 26 March 2025; to date, 35 of the target 76 participants have been recruited.
Read the detailed description
Adolescent idiopathic scoliosis (AIS) is the most prevalent form of scoliosis, affecting 2% to 4% of the global teenage population and imposing substantial physical and psychological burdens. In China, a 2024 systematic review and modelling study estimated that the prevalence of idiopathic scoliosis among children aged 5-18 years was 0.79% in 2020, corresponding to approximately 1.81 million affected children. Current conservative follow-up management for adolescents with AIS remains fragmented under routine clinical settings, with limited integration across home, school, and hospital care.
This trial evaluates the clinical effectiveness of a comprehensive digital health management platform that supports a clinician-supervised, home-school-hospital collaborative care pathway for the conservative management of adolescents with established AIS. The platform integrates nine functional modules: electronic health records, disease risk early warning, health intervention and promotion, standardized health education, follow-up management, system administration, data quality control and review, data analysis and utilization, and visual data display. It serves solely as a clinical decision-support tool; all platform-generated recommendations must be manually reviewed, adjusted, and formally approved by licensed clinicians before being shared with patients.
The trial is a single-center, superiority, parallel-group, 1:1 randomized controlled trial with assessor-blinded outcome evaluation. A total of 76 eligible adolescents with mild-to-moderate AIS (Cobb angle 10 degrees to less than 45 degrees, aged 12-16 years) will be randomly allocated to either the control group receiving routine guideline-based conservative care or the intervention group receiving clinician-supervised, platform-supported collaborative care. Both groups have access to the same guideline-based conservative treatment options, including observation, physiotherapeutic scoliosis-specific exercises (PSSE), specialized inpatient rehabilitation, and bracing, in accordance with the 2016 SOSORT guidelines. Randomization will be stratified by baseline Cobb-angle strata (10-24 degrees vs 25-44 degrees) and skeletal maturity (Risser 0-2 vs Risser 3-5).
Outcome assessments will be conducted at baseline and at 4, 8, and 12 months. The primary outcome is the change in Cobb angle from baseline to the 4-month endpoint. Secondary outcomes include treatment adherence, mental-health status (assessed with the Hamilton Depression Rating Scale-17), cumulative direct out-of-pocket medical expenditure, participant and guardian satisfaction, and safety outcomes. The primary analysis will follow the intention-to-treat principle and will use analysis of covariance adjusting for baseline Cobb angle. Sensitivity analyses include per-protocol analysis, multiple imputation under missing-at-random assumptions, complete-case analysis, and pattern-mixture-model-based analyses for missing-not-at-random scenarios.
The first participant was enrolled on 26 March 2025. To date, 35 of the target 76 participants have been recruited. No primary endpoint outcome data have been unlocked or analysed at the time of this protocol version.
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Being tested
- Routine Guideline-Based Conservative Care, Clinician-Supervised, Platform-Assisted Conservative Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Guideline-Based Conservative CareOther
Routine conservative management according to the 2016 SOSORT guidelines, comprising observation, physiotherapeutic scoliosis-specific exercises, specialized inpatient rehabilitation, and bracing as clinically indicated. Delivered through routine outpatient consultations; participants have no access to the digital health management platform.
Clinician-Supervised, Platform-Assisted Conservative ManagementBehavioural
Individualized conservative management supported by the comprehensive digital health management platform. The platform generates decision-support recommendations for observation, PSSE, specialized inpatient rehabilitation, or bracing, which must be reviewed, modified as needed, and formally approved by licensed clinicians before implementation. Platform functions include treatment reminders, standardized health education, follow-up scheduling, and home-school-hospital communication. The platform serves solely as a clinical decision-support tool and cannot generate automatic prescriptions or override clinical judgement.
| Study group | Role | What they receive |
|---|---|---|
| Routine Guideline-Based Conservative Care | Active comparator | Control participants will receive routine clinician-directed conservative management in accordance with the 2016 SOSORT guidelines, including observation (follow-up every 3-8 months), physiotherapeutic scoliosis-specific exercises (PSSE, 2-7 sessions per week), specialized inpatient rehabilitation (SIR, a 4-week intensive program of 1 h/day, 5 days/week), and bracing (nighttime rigid bracing 8 h/day; part-time rigid bracing 15 h/day; full-time rigid bracing 20 h/day) as clinically indicated. Care is delivered through routine outpatient visits, paper-based education materials, and clinic-driven follow-up reminders via telephone or SMS. Participants in this arm have no access to the digital health management platform. Receives: Other: Routine Guideline-Based Conservative Care |
| Platform-Supported Individualized Conservative Care | Experimental | Intervention participants will receive individualized conservative management supported by the comprehensive digital health management platform and supervised by licensed clinicians. The same guideline-based treatment options as the control group are available (observation, PSSE, specialized inpatient rehabilitation, and bracing), with treatment selection rules strictly following the 2016 SOSORT guidelines. The platform generates decision-support recommendations based on clinical characteristics, radiographic findings, and lifestyle-related risk factors; all platform-generated suggestions must be manually reviewed, adjusted, and formally approved by a licensed clinician before implementation. The platform provides treatment reminders, standardized health education, follow-up scheduling, and secure cross-party communication linking participants, families, schools, and healthcare providers (home-school-hospital collaborative care model). Receives: Behavioral: Clinician-Supervised, Platform-Assisted Conservative Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cobb Angle
Change in Cobb angle from baseline to the 4-month endpoint (baseline Cobb angle minus 4-month Cobb angle; positive value represents curve improvement). Cobb angle will be measured on standing posteroanterior full-spine radiographs by two independent outcome assessors blinded to group allocation, following SRS measurement protocols; a third senior spine specialist arbitrates when disagreement exceeds 3 degrees. Patients wearing braces must remove the brace for at least 24 hours before radiography.
Measured: Baseline and Month 4 (primary endpoint)
Secondary outcomes (5)
Treatment Adherence
For participants prescribed PSSE: exercise adherence = number of completed prescribed PSSE sessions / total number of prescribed sessions x 100%. For participants prescribed bracing: brace-wear adherence = actual wear-time / prescribed daily wear-time x 100%. For participants under observation-only, adherence is coded as not-applicable. Identical definitions and assessment intervals are used in both groups.
Measured: Throughout the 4-month intervention period
Mental Health Status (Hamilton Depression Rating Scale-17)
Depression status will be assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17). Trained research investigators will perform face-to-face clinician-rated interviews adapted for adolescent participants.
Measured: Baseline, Month 4, Month 8, and Month 12
Direct Out-of-Pocket Medical Expenditure
Cumulative direct out-of-pocket medical expenses related to scoliosis management will be recorded from the family/guardian societal perspective.
Measured: Month 4 and Month 12
Participant and Guardian Satisfaction
Participant and guardian satisfaction will be evaluated using a previously validated custom standardized satisfaction questionnaire (provided within the supplementary material).
Measured: Month 4 and Month 12
Safety Outcomes (Adverse Events)
Adverse events and serious adverse events will be recorded and graded according to CTCAE version 5.0. Serious adverse events will be reported to the ethics committee; participants experiencing SAEs do not automatically withdraw from the trial.
Measured: Baseline, Month 4, Month 8, and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start26 Mar 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group, 1:1 allocation, superiority design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinyun Li, doctor, Principal investigator, Hangzhou Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314594
- Sponsor's protocol ID
- KT2024017
- Other IDs
- Other registry
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06314594
- Acronym / sponsor ID
- KT2024017
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Hangzhou Medical CollegeUniversity, hospital or other
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Mar 2024 (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.
Adolescent idiopathic scoliosis (AIS) brings substantial physical and psychological burden to affected teenagers, and current conservative follow-up management is fragmented under routine clinical settings. This single-center, superiority, parallel-group, 1:1 randomized controlled trial with assessor-blinded outcome evaluation will compare a clinician-supervised, platform-supported collaborative care pathway with routine guideline-based conservative care in 76 adolescents with mild-to-moderate AIS. Participants will be assessed at baseline, 4-month (primary endpoint), 8-month, and 12-month follow-up. The primary outcome is the change in Cobb angle from baseline to 4 months. Secondary outcomes include treatment adherence, mental-health status, medical expenditure, participant and guardian satisfaction, and safety outcomes. The primary analysis will follow the intention-to-treat principle. The first participant was enrolled on 26 March 2025; to date, 35 of the target 76 participants have been recruited.
Detailed description
Adolescent idiopathic scoliosis (AIS) is the most prevalent form of scoliosis, affecting 2% to 4% of the global teenage population and imposing substantial physical and psychological burdens. In China, a 2024 systematic review and modelling study estimated that the prevalence of idiopathic scoliosis among children aged 5-18 years was 0.79% in 2020, corresponding to approximately 1.81 million affected children. Current conservative follow-up management for adolescents with AIS remains fragmented under routine clinical settings, with limited integration across home, school, and hospital care.
This trial evaluates the clinical effectiveness of a comprehensive digital health management platform that supports a clinician-supervised, home-school-hospital collaborative care pathway for the conservative management of adolescents with established AIS. The platform integrates nine functional modules: electronic health records, disease risk early warning, health intervention and promotion, standardized health education, follow-up management, system administration, data quality control and review, data analysis and utilization, and visual data display. It serves solely as a clinical decision-support tool; all platform-generated recommendations must be manually reviewed, adjusted, and formally approved by licensed clinicians before being shared with patients.
The trial is a single-center, superiority, parallel-group, 1:1 randomized controlled trial with assessor-blinded outcome evaluation. A total of 76 eligible adolescents with mild-to-moderate AIS (Cobb angle 10 degrees to less than 45 degrees, aged 12-16 years) will be randomly allocated to either the control group receiving routine guideline-based conservative care or the intervention group receiving clinician-supervised, platform-supported collaborative care. Both groups have access to the same guideline-based conservative treatment options, including observation, physiotherapeutic scoliosis-specific exercises (PSSE), specialized inpatient rehabilitation, and bracing, in accordance with the 2016 SOSORT guidelines. Randomization will be stratified by baseline Cobb-angle strata (10-24 degrees vs 25-44 degrees) and skeletal maturity (Risser 0-2 vs Risser 3-5).
Outcome assessments will be conducted at baseline and at 4, 8, and 12 months. The primary outcome is the change in Cobb angle from baseline to the 4-month endpoint. Secondary outcomes include treatment adherence, mental-health status (assessed with the Hamilton Depression Rating Scale-17), cumulative direct out-of-pocket medical expenditure, participant and guardian satisfaction, and safety outcomes. The primary analysis will follow the intention-to-treat principle and will use analysis of covariance adjusting for baseline Cobb angle. Sensitivity analyses include per-protocol analysis, multiple imputation under missing-at-random assumptions, complete-case analysis, and pattern-mixture-model-based analyses for missing-not-at-random scenarios.
The first participant was enrolled on 26 March 2025. To date, 35 of the target 76 participants have been recruited. No primary endpoint outcome data have been unlocked or analysed at the time of this protocol version.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-group, 1:1 allocation, superiority design.
| Arm | Type | Receives |
|---|---|---|
| Routine Guideline-Based Conservative Care | Active comparator | Other: Routine Guideline-Based Conservative CareControl participants will receive routine clinician-directed conservative management in accordance with the 2016 SOSORT guidelines, including observation (follow-up every 3-8 months), physiotherapeutic scoliosis-specific exercises (PSSE, 2-7 sessions per week), specialized inpatient rehabilitation (SIR, a 4-week intensive program of 1 h/day, 5 days/week), and bracing (nighttime rigid bracing 8 h/day; part-time rigid bracing 15 h/day; full-time rigid bracing 20 h/day) as clinically indicated. Care is delivered through routine outpatient visits, paper-based education materials, and clinic-driven follow-up reminders via telephone or SMS. Participants in this arm have no access to the digital health management platform. |
| Platform-Supported Individualized Conservative Care | Experimental | Behavioral: Clinician-Supervised, Platform-Assisted Conservative ManagementIntervention participants will receive individualized conservative management supported by the comprehensive digital health management platform and supervised by licensed clinicians. The same guideline-based treatment options as the control group are available (observation, PSSE, specialized inpatient rehabilitation, and bracing), with treatment selection rules strictly following the 2016 SOSORT guidelines. The platform generates decision-support recommendations based on clinical characteristics, radiographic findings, and lifestyle-related risk factors; all platform-generated suggestions must be manually reviewed, adjusted, and formally approved by a licensed clinician before implementation. The platform provides treatment reminders, standardized health education, follow-up scheduling, and secure cross-party communication linking participants, families, schools, and healthcare providers (home-school-hospital collaborative care model). |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Confirmed diagnosis of mild-to-moderate Adolescent Idiopathic Scoliosis (AIS), with a Cobb angle of 10 degrees or greater and less than 45 degrees.
- Age 12 to 16 years, targeting adolescents in the active pubertal growth phase, in whom conservative management (PSSE and bracing) is clinically prioritized.
- Sufficient cognitive and communicative ability to understand the study procedures and use the platform.
- Voluntary participation confirmed by signed guardian informed consent and adolescent participant assent.
- Participants with prior conservative treatment (PSSE or bracing) are eligible provided the treatment regimen has been stable for at least 3 months prior to baseline assessment.
Key exclusion criteria (4 listed)
- Secondary scoliosis caused by identifiable causes such as spinal trauma or prior spinal surgery.
- Clinically significant severe functional impairment of heart, liver, or kidney organ function, defined as grade 3 or higher organ dysfunction according to CTCAE version 5.0.
- Malignant tumours, autoimmune diseases, or other critical systemic illnesses that may interfere with trial outcomes.
- Severe cognitive or psychiatric conditions, including diagnosed intellectual disability, psychotic disorders, or major depressive disorder under active psychiatric intervention, that prevent obtaining valid assent or completing study assessments.
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 |
|---|---|---|
| Routine Guideline-Based Conservative CareRoutine conservative management according to the 2016 SOSORT guidelines, comprising observation, physiotherapeutic scoliosis-specific exercises, specialized inpatient rehabilitation, and bracing as clinically indicated. Delivered through routine outpatient consultations; participants have no access to the digital health management platform. | Other | Routine Guideline-Based Conservative Care |
| Clinician-Supervised, Platform-Assisted Conservative ManagementIndividualized conservative management supported by the comprehensive digital health management platform. The platform generates decision-support recommendations for observation, PSSE, specialized inpatient rehabilitation, or bracing, which must be reviewed, modified as needed, and formally approved by licensed clinicians before implementation. Platform functions include treatment reminders, standardized health education, follow-up scheduling, and home-school-hospital communication. The platform serves solely as a clinical decision-support tool and cannot generate automatic prescriptions or override clinical judgement. | Behavioural | Platform-Supported Individualized Conservative Care |
Primary outcome
Change in Cobb Angle
Time frame: Baseline and Month 4 (primary endpoint)
Change in Cobb angle from baseline to the 4-month endpoint (baseline Cobb angle minus 4-month Cobb angle; positive value represents curve improvement). Cobb angle will be measured on standing posteroanterior full-spine radiographs by two independent outcome assessors blinded to group allocation, following SRS measurement protocols; a third senior spine specialist arbitrates when disagreement exceeds 3 degrees. Patients wearing braces must remove the brace for at least 24 hours before radiography.
5 secondary outcomes
Treatment Adherence
Time frame: Throughout the 4-month intervention period
Mental Health Status (Hamilton Depression Rating Scale-17)
Time frame: Baseline, Month 4, Month 8, and Month 12
Direct Out-of-Pocket Medical Expenditure
Time frame: Month 4 and Month 12
Participant and Guardian Satisfaction
Time frame: Month 4 and Month 12
Safety Outcomes (Adverse Events)
Time frame: Baseline, Month 4, Month 8, and Month 12
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 27 Oct 2026.
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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.
Xinyun Li, doctor principal investigator
Hangzhou Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Guideline-Based Conservative Care and Clinician-Supervised, Platform-Assisted Conservative Management in people with Adolescent Idiopathic Scoliosis (AIS), run by Hangzhou Medical College at 1 site in China.
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 5 inclusion and 4 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 27 Oct 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 China. 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 Xinyun LI, Doctor (8618069783240, lxyjasmine2010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cobb Angle (time frame: Baseline and Month 4 (primary endpoint)). 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 27 Oct 2026.