Adolescent Idiopathic Scoliosis (AIS)AIS-DTx-RCTNCT07341633
AI-Based Digital Therapeutics vs. Traditional Schroth Exercises for Adolescent Idiopathic Scoliosis
A study testing AI-Based Digital Therapeutic System and Standard Outpatient Schroth Therapy in people with Adolescent Idiopathic Scoliosis (AIS), run by Jinan University Guangzhou at 1 site in China.
Trial summary
This randomized controlled trial (RCT) evaluates the efficacy of a novel Artificial Intelligence (AI)-based digital therapeutic system compared to traditional outpatient Schroth exercises for the treatment of Adolescent Idiopathic Scoliosis (AIS). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS)
- What is being tested?
- AI-Based Digital Therapeutic System and Standard Outpatient Schroth Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 Jan 2028
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Adolescent Idiopathic Scoliosis (AIS).
- Age between 10 and 18 years (inclusive).
- Cobb angle of the major curve between 10° and 30°.
- Risser sign 0-2 (indicating skeletal immaturity).
- Ability to operate a smartphone and follow instructions for the digital therapeutic application.
- Patient and legal guardian provide written informed consent.
Who cannot join
- Non-idiopathic scoliosis (e.g., congenital, neuromuscular, or syndromic etiology).
- History of prior spinal surgery or currently scheduled for surgery.
- Contraindications to exercise therapy (e.g., cardiac or respiratory insufficiency).
- Severe cognitive or psychiatric disorders that prevent compliance with the protocol.
- Currently receiving other scoliosis-specific treatments (e.g., bracing) outside of the study protocol (unless stratified).
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623
About this study
Official title: Efficacy of Artificial Intelligence-Based Digital Therapeutics Versus Traditional Schroth Exercises for Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial
This randomized controlled trial (RCT) evaluates the efficacy of a novel Artificial Intelligence (AI)-based digital therapeutic system compared to traditional outpatient Schroth exercises for the treatment of Adolescent Idiopathic Scoliosis (AIS). The intervention utilizes a smartphone application with computer vision technology to perform remote, personalized posture analysis and generate adaptive exercise prescriptions. The study aims to determine if this "Human-in-the-Loop" AI model demonstrates superior clinical outcomes in controlling spinal curve progression and improving treatment adherence compared to standard conservative care over a 6-month period.
Read the detailed description
Background: Adolescent Idiopathic Scoliosis (AIS) requires long-term conservative management to prevent curve progression. While Physiotherapeutic Scoliosis Specific Exercises (PSSE), such as the Schroth method, are the gold standard, their efficacy is often limited by accessibility barriers and suboptimal adherence.
Study Design: This is a parallel-group, single-blind randomized controlled trial. A total of 300 eligible adolescents (aged 10-18, Cobb angle 10-30°, Risser sign 0-2) will be randomized in a 1:1 ratio into an Intervention Group or a Control Group.
Interventions:
Intervention Group (AI-DTx): Participants utilize a smartphone application to capture standardized photos every two weeks. An AI algorithm (based on MediaPipe) extracts skeletal landmarks to classify curve patterns and assign personalized exercise modules. The system features a "Check-and-Adjust" matrix to adapt exercise intensity based on metric changes. A Clinical Research Assistant (Human-in-the-Loop) verifies all prescriptions for safety before release.
Control Group (Standard Care): Participants receive standard outpatient Schroth therapy, involving daily home exercises and monthly supervised clinic visits, following SOSORT guidelines.
Objectives: The primary objective is to evaluate the absolute change in the major curve Cobb angle from baseline to six months. Secondary outcomes include the Angle of Trunk Rotation (ATR), trunk appearance perception (TAPS), quality of life (SRS-22r), and adherence rates. The study hypothesizes that the AI-driven intervention will demonstrate superior efficacy and adherence compared to traditional outpatient care.
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Being tested
- AI-Based Digital Therapeutic System, Standard Outpatient Schroth Therapy
- Keywords
- Digital Therapeutics, Artificial Intelligence, Schroth Method, Tele-rehabilitation, Computer Vision, Scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Based Digital Therapeutic SystemDevice
A smartphone-based digital therapeutic application that utilizes computer vision (MediaPipe Framework) to capture and analyze patient posture bi-weekly. The system employs a hierarchical triage logic to classify curve patterns and assign personalized Schroth-based exercise modules. It features a "Human-in-the-Loop" safety protocol where a Clinical Research Assistant validates the AI-generated prescription before release. The exercise dosing (intensity and props) is adaptively adjusted based on the calculated metric changes (NSI) every two weeks .
Standard Outpatient Schroth TherapyBehavioural
Standard conservative management based on the SOSORT and Schroth Best Practice guidelines. Participants undergo an initial 60-minute comprehensive evaluation and education session. The intervention consists of a daily home exercise program (30 minutes/day) and mandatory monthly face-to-face supervised sessions at the outpatient clinic, where a certified therapist manually adjusts the exercise prescription based on clinical progression .
| Study group | Role | What they receive |
|---|---|---|
| Standard Outpatient Schroth Therapy | Active comparator | Participants receive standard conservative care based on Schroth Best Practice guidelines. This involves an initial 60-minute comprehensive evaluation, followed by a personalized home exercise program (30 minutes daily). Participants attend monthly supervised sessions at the outpatient clinic for manual prescription adjustments by a certified therapist . Receives: Behavioral: Standard Outpatient Schroth Therapy |
| AI-Based Digital Therapeutics (AI-DTx) | Experimental | Participants utilize a smartphone application to capture standardized photos every two weeks. An AI algorithm (MediaPipe-based) processes these images to classify curve patterns and assign personalized exercise modules. The system uses a "Human-in-the-Loop" workflow where a Clinical Research Assistant verifies the AI-generated prescription before release. Dosing intensity is adaptively adjusted based on metric changes. Receives: Device: AI-Based Digital Therapeutic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in Major Curve Cobb Angle
Measured on standardized standing posteroanterior full-spine radiographs. The Cobb angle is the angle formed between the upper endplate of the most tilted upper vertebra and the lower endplate of the most tilted lower vertebra. Measurements are performed in degrees by independent radiologists who are blinded to group allocation. A negative value indicates a reduction (improvement) in the spinal curve.
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (4)
Treatment Adherence Rate
Calculated as the percentage of completed exercise sessions relative to the prescribed sessions. For the Intervention group, adherence is logged automatically by the app via computer vision verification. For the Control group, adherence is self-reported via paper logs.
Measured: Baseline, 3 months, and 6 months
Change in Angle of Trunk Rotation (ATR)
Measured using a Scoliometer during the Adam's Forward Bend Test. The maximum rotation angle of the trunk is recorded in degrees.
Measured: Baseline, 3 months, and 6 months
Change in Quality of Life (SRS-22r Score)
Assessed using the Scoliosis Research Society-22 revised (SRS-22r) questionnaire. The score ranges from 1 to 5, with higher scores indicating better patient outcomes across domains of function, pain, self-image, and mental health.
Measured: Baseline, 3 months, and 6 months
Change in Trunk Appearance Perception (TAPS)
Assessed using the Trunk Appearance Perception Scale (TAPS), a patient-reported outcome measure of self-perceived trunk deformity. Scores range from 1 (worst) to 5 (best).
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Feb 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- A parallel-group, single-blind randomized controlled trial comparing an AI-based digital therapeutic intervention against a standard care control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinan University Guangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Women and Children's Medical Center
- Responsible party
- Principal investigator, Ma Ruisi, Jinan University Guangzhou
- Investigators
- Lili Shu, MD, Principal investigator, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341633
- Sponsor's protocol ID
- GWCMC-2025-497A01
- Acronym
- AIS-DTx-RCT
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results, including baseline demographics, Risser sign, Cobb angle, Angle of Trunk Rotation, TAPS scores, SRS-22r scores, and adherence metrics for all randomised participants, will be made available. All data will be anonymised prior to sharing; no facial images or directly identifying information will be released.
Publications
Ma R, Huang Z, Zhu X, Ma X, Cheng W, Tang D, Liu J, Shu L. Efficacy of artificial intelligence-based digital therapeutics versus traditional Schroth exercises for adolescent idiopathic scoliosis: protocol for a randomised controlled trial. BMJ Open. 2026 May 24;16(5):e116834. doi: 10.1136/bmjopen-2026-116834.
PubMed 42192639
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Artificial Intelligence-Based Digital Therapeutics Versus Traditional Schroth Exercises for Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07341633
- Acronym / sponsor ID
- AIS-DTx-RCT / GWCMC-2025-497A01
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Keywords
- Digital Therapeutics, Artificial Intelligence, Schroth Method, Tele-rehabilitation, Computer Vision, Scoliosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jinan University GuangzhouUniversity, hospital or other
- Collaborators
- Guangzhou Women and Children's Medical Center
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 14 Jan 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.
This randomized controlled trial (RCT) evaluates the efficacy of a novel Artificial Intelligence (AI)-based digital therapeutic system compared to traditional outpatient Schroth exercises for the treatment of Adolescent Idiopathic Scoliosis (AIS). The intervention utilizes a smartphone application with computer vision technology to perform remote, personalized posture analysis and generate adaptive exercise prescriptions. The study aims to determine if this "Human-in-the-Loop" AI model demonstrates superior clinical outcomes in controlling spinal curve progression and improving treatment adherence compared to standard conservative care over a 6-month period.
Detailed description
Background: Adolescent Idiopathic Scoliosis (AIS) requires long-term conservative management to prevent curve progression. While Physiotherapeutic Scoliosis Specific Exercises (PSSE), such as the Schroth method, are the gold standard, their efficacy is often limited by accessibility barriers and suboptimal adherence.
Study Design: This is a parallel-group, single-blind randomized controlled trial. A total of 300 eligible adolescents (aged 10-18, Cobb angle 10-30°, Risser sign 0-2) will be randomized in a 1:1 ratio into an Intervention Group or a Control Group.
Interventions:
Intervention Group (AI-DTx): Participants utilize a smartphone application to capture standardized photos every two weeks. An AI algorithm (based on MediaPipe) extracts skeletal landmarks to classify curve patterns and assign personalized exercise modules. The system features a "Check-and-Adjust" matrix to adapt exercise intensity based on metric changes. A Clinical Research Assistant (Human-in-the-Loop) verifies all prescriptions for safety before release.
Control Group (Standard Care): Participants receive standard outpatient Schroth therapy, involving daily home exercises and monthly supervised clinic visits, following SOSORT guidelines.
Objectives: The primary objective is to evaluate the absolute change in the major curve Cobb angle from baseline to six months. Secondary outcomes include the Angle of Trunk Rotation (ATR), trunk appearance perception (TAPS), quality of life (SRS-22r), and adherence rates. The study hypothesizes that the AI-driven intervention will demonstrate superior efficacy and adherence compared to traditional outpatient care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel-group, single-blind randomized controlled trial comparing an AI-based digital therapeutic intervention against a standard care control group.
| Arm | Type | Receives |
|---|---|---|
| Standard Outpatient Schroth Therapy | Active comparator | Behavioral: Standard Outpatient Schroth TherapyParticipants receive standard conservative care based on Schroth Best Practice guidelines. This involves an initial 60-minute comprehensive evaluation, followed by a personalized home exercise program (30 minutes daily). Participants attend monthly supervised sessions at the outpatient clinic for manual prescription adjustments by a certified therapist . |
| AI-Based Digital Therapeutics (AI-DTx) | Experimental | Device: AI-Based Digital Therapeutic SystemParticipants utilize a smartphone application to capture standardized photos every two weeks. An AI algorithm (MediaPipe-based) processes these images to classify curve patterns and assign personalized exercise modules. The system uses a "Human-in-the-Loop" workflow where a Clinical Research Assistant verifies the AI-generated prescription before release. Dosing intensity is adaptively adjusted based on metric changes. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Diagnosis of Adolescent Idiopathic Scoliosis (AIS).
- Age between 10 and 18 years (inclusive).
- Cobb angle of the major curve between 10° and 30°.
- Risser sign 0-2 (indicating skeletal immaturity).
- Ability to operate a smartphone and follow instructions for the digital therapeutic application.
Key exclusion criteria (5 listed)
- Non-idiopathic scoliosis (e.g., congenital, neuromuscular, or syndromic etiology).
- History of prior spinal surgery or currently scheduled for surgery.
- Contraindications to exercise therapy (e.g., cardiac or respiratory insufficiency).
- Severe cognitive or psychiatric disorders that prevent compliance with the protocol.
- Currently receiving other scoliosis-specific treatments (e.g., bracing) outside of the study protocol (unless stratified).
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 |
|---|---|---|
| AI-Based Digital Therapeutic SystemA smartphone-based digital therapeutic application that utilizes computer vision (MediaPipe Framework) to capture and analyze patient posture bi-weekly. The system employs a hierarchical triage logic to classify curve patterns and assign personalized Schroth-based exercise modules. It features a "Human-in-the-Loop" safety protocol where a Clinical Research Assistant validates the AI-generated prescription before release. The exercise dosing (intensity and props) is adaptively adjusted based on the calculated metric changes (NSI) every two weeks . | Device | AI-Based Digital Therapeutics (AI-DTx) |
| Standard Outpatient Schroth TherapyStandard conservative management based on the SOSORT and Schroth Best Practice guidelines. Participants undergo an initial 60-minute comprehensive evaluation and education session. The intervention consists of a daily home exercise program (30 minutes/day) and mandatory monthly face-to-face supervised sessions at the outpatient clinic, where a certified therapist manually adjusts the exercise prescription based on clinical progression . | Behavioural | Standard Outpatient Schroth Therapy |
Primary outcome
Absolute Change in Major Curve Cobb Angle
Time frame: Baseline, 3 months, and 6 months
Measured on standardized standing posteroanterior full-spine radiographs. The Cobb angle is the angle formed between the upper endplate of the most tilted upper vertebra and the lower endplate of the most tilted lower vertebra. Measurements are performed in degrees by independent radiologists who are blinded to group allocation. A negative value indicates a reduction (improvement) in the spinal curve.
4 secondary outcomes
Treatment Adherence Rate
Time frame: Baseline, 3 months, and 6 months
Change in Angle of Trunk Rotation (ATR)
Time frame: Baseline, 3 months, and 6 months
Change in Quality of Life (SRS-22r Score)
Time frame: Baseline, 3 months, and 6 months
Change in Trunk Appearance Perception (TAPS)
Time frame: Baseline, 3 months, and 6 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 23 Apr 2026.
- Derived from this study: PubMed 42192639Ma R, Huang Z, Zhu X, Ma X, Cheng W, Tang D, Liu J, Shu L. Efficacy of artificial intelligence-based digital therapeutics versus traditional Schroth exercises for adolescent idiopathic scoliosis: protocol for a randomised controlled trial. BMJ Open. 2026 May 24;16(5):e116834. doi: 10.1136/bmjopen-2026-116834.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results, including baseline demographics, Risser sign, Cobb angle, Angle of Trunk Rotation, TAPS scores, SRS-22r scores, and adherence metrics for all randomised participants, will be made available. All data will be anonymised prior to sharing; no facial images or directly identifying information will be released.
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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. This study is not recruiting at the moment.
Lili Shu, MD principal investigator
Guangzhou Women and Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Based Digital Therapeutic System and Standard Outpatient Schroth Therapy in people with Adolescent Idiopathic Scoliosis (AIS), run by Jinan University Guangzhou 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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Change in Major Curve Cobb Angle (time frame: Baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07341633, which also lists 1 linked publication.
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 23 Apr 2026.