Adolescent Idiopathic ScoliosisAR-SCOLIONCT07201103
Augmented Reality-Based Exercise Training in Adolescents With Idiopathic Scoliosis
A study testing Conventional PSSE-Schroth and AR-Assisted PSSE-Schroth in people with Adolescent Idiopathic Scoliosis, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial investigates the effects of augmented reality (AR)-based exercise training in adolescents with idiopathic scoliosis. Participants are randomly assigned to either a control group receiving conventional Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) or an intervention… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Conventional PSSE-Schroth and AR-Assisted PSSE-Schroth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents clinically diagnosed with idiopathic scoliosis (AIS)
- Cobb angle between 10° and 30°
- Age range: 10-18 years
- No history of spinal surgery
- Ability to regularly participate in the exercise program
- Signed informed consent obtained from both participants and their parents
Who cannot join
- Diagnosis of neuromuscular, congenital, or secondary scoliosis
- Previous history of spinal surgery
- Presence of severe cardiovascular, respiratory, or musculoskeletal conditions preventing participation in exercise
- Visual, auditory, or perceptual impairments that would hinder participation in augmented reality-based training
- Concurrent participation in another physiotherapy or rehabilitation program during the study period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hasan Kalyoncu University
Gaziantep, Şahinbey, 27010
About this study
Official title: The Effects of Augmented Reality-Based Exercise Training on Body Awareness, Trunk Appearance Perception, and Exercise Adherence in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial
This randomized controlled trial investigates the effects of augmented reality (AR)-based exercise training in adolescents with idiopathic scoliosis. Participants are randomly assigned to either a control group receiving conventional Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) or an intervention group receiving AR-assisted PSSE-Schroth exercises. The primary outcomes include body awareness, trunk appearance perception, and exercise adherence. The study aims to evaluate whether AR-assisted training provides additional benefits over conventional therapy in improving postural control, perception, and compliance in scoliosis management.
Read the detailed description
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that may negatively affect posture, body image, and adherence to exercise-based rehabilitation. While Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) are widely accepted as a conservative treatment method, adherence and perception-related factors remain challenging.
This study is designed as a parallel-group, randomized controlled trial comparing conventional PSSE-Schroth exercises with AR-assisted PSSE-Schroth training. A total of 30 adolescents diagnosed with AIS were enrolled and randomized into two groups:
Control Group: received supervised PSSE-Schroth exercises.
Intervention Group: received supervised AR-assisted PSSE-Schroth exercises.
The intervention lasted 12 weeks, and participants were evaluated at baseline and post-intervention.
Primary outcome measures include body awareness (Awareness-Body-Chart), trunk appearance perception (Walter Reed Visual Assessment Scale, Spinal Appearance Questionnaire), and exercise adherence (Exercise Adherence Rating Scale).
Secondary outcome measures include Cobb angle, vertebral rotation, pain intensity, and treatment satisfaction.
The study hypothesizes that AR-assisted PSSE-Schroth training will enhance body awareness, improve trunk appearance perception, and increase adherence compared to conventional methods. This research may provide new insights into integrating digital technologies into scoliosis rehabilitation and contribute to developing innovative, patient-centered approaches in physiotherapy.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Conventional PSSE-Schroth, AR-Assisted PSSE-Schroth
- Keywords
- Scoliosis, Adolescent Idiopathic Scoliosis, AR-based Rehabilitation, Augmented Reality Exercise Training, Physiotherapeutic Scoliosis-Specific Exercises (PSSE), Schroth Method, Exercise Adherence, Body Awareness, Trunk Appearance Perception
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PSSE-SchrothBehavioural
Also called Schroth Method
Participants performed conventional Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) for 4 weeks. The program consisted of one 45-minute supervised session per week complemented by home-based exercises. The exercises focused on posture correction, spinal alignment, and corrective breathing techniques according to standard scoliosis rehabilitation protocols.
AR-Assisted PSSE-SchrothBehavioural
Also called Augmented Reality Exercise Training
Participants performed Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) enhanced with augmented reality (AR) support for 4 weeks. The intervention included one 45-minute supervised session per week, plus home-based exercises. The AR system provided real-time visual and kinesthetic feedback during exercise sessions to improve body awareness, trunk appearance perception, and adherence.
| Study group | Role | What they receive |
|---|---|---|
| Control - Conventional PSSE-Schroth | Active comparator | Participants in this group received supervised conventional Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) for 4 weeks. The program included one 45-minute supervised session per week, complemented by home exercises. Established scoliosis rehabilitation protocols focusing on posture correction, breathing, and spinal alignment were followed. Receives: Behavioral: Conventional PSSE-Schroth |
| Experimental - AR-assisted PSSE-Schroth | Experimental | Participants in this group received supervised augmented reality (AR)-assisted Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) for 4 weeks. The intervention included one 45-minute supervised session per week, supplemented with home exercises. Augmented reality technology was used to provide real-time visual and kinesthetic feedback, aiming to enhance posture correction, breathing patterns, and spinal alignment. Receives: Behavioral: AR-Assisted PSSE-Schroth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Awareness (ABC - Vücut Farkındalık Çizelgesi)
Body awareness will be assessed using the standardized Awareness-Body-Chart (ABC). Participants rate awareness of different body regions, and a total score is calculated. The outcome is the change in total ABC score from baseline (T0) to the end of intervention (T4, 4th week). A higher score indicates greater body awareness.
Measured: Baseline (T0) and 4 weeks after intervention (T4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Jan 2025
- Primary completion1 Jul 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Adolescent 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly allocated to either the control group (conventional PSSE-Schroth) or the intervention group (AR-assisted PSSE-Schroth). Both groups received supervised exercise training over 12 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Adnan Batuhan Coskun, Hasan Kalyoncu University
- Investigators
- Adnan B Coşkun, PhD, Principal investigator, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201103
- Sponsor's protocol ID
- 323S271
- Other IDs
- TÜBİTAK 1001 Projesi - 323S271
- Acronym
- AR-SCOLIO
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage, the decision on sharing individual participant data (IPD) is undecided. As the study is supported by TÜBİTAK (The Scientific and Technological Research Council of Turkey), any data sharing must comply with the funder's policies, ethical approval requirements, and national data protection regulations. The research team is committed to transparency and is open to sharing de-identified, anonymized data upon reasonable request from qualified researchers. Such sharing will only take place after publication of the study results, and contingent upon TÜBİTAK's approval and the execution of appropriate data-sharing agreements to ensure participant confidentiality and compliance with legal and ethical standards.
Publications
Yuan W, Shi W, Chen L, Liu D, Lin Y, Li Q, Lu J, Zhang H, Feng Q, Zhang H; Digital Care Study Group. Digital Physiotherapeutic Scoliosis-Specific Exercises for Adolescent Idiopathic Scoliosis: A Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2459929. doi: 10.1001/jamanetworkopen.2024.59929.
PubMed 39964686Cavalcanti, V. C., Ferreira, M. I. d. S., Teichrieb, V., Barioni, R. R., Correia, W. F. M., Da Gama, A. E. F. 2019. "Usability and effects of text, image and audio feedback on exercise correction during augmented reality based motor rehabilitation", Computers & Graphics, 85, 100-10.
Kocaman H, Bek N, Kaya MH, Buyukturan B, Yetis M, Buyukturan O. The effectiveness of two different exercise approaches in adolescent idiopathic scoliosis: A single-blind, randomized-controlled trial. PLoS One. 2021 Apr 15;16(4):e0249492. doi: 10.1371/journal.pone.0249492. eCollection 2021.
PubMed 33857180Buyukturan O, Kaya MH, Alkan H, Buyukturan B, Erbahceci F. Comparison of the efficacy of Schroth and Lyon exercise treatment techniques in adolescent idiopathic scoliosis: A randomized controlled, assessor and statistician blinded study. Musculoskelet Sci Pract. 2024 Aug;72:102952. doi: 10.1016/j.msksp.2024.102952. Epub 2024 Apr 12.
PubMed 38631273Chen C, Xu J, Li H. Effects of Schroth 3D Exercise on Adolescent Idiopathic Scoliosis: A Systematic Review and Meta-Analysis. Children (Basel). 2024 Jul 1;11(7):806. doi: 10.3390/children11070806.
PubMed 39062255Schreiber S, Parent EC, Khodayari Moez E, Hedden DM, Hill DL, Moreau M, Lou E, Watkins EM, Southon SC. Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial. PLoS One. 2016 Dec 29;11(12):e0168746. doi: 10.1371/journal.pone.0168746. eCollection 2016.
PubMed 28033399Berdishevsky H, Lebel VA, Bettany-Saltikov J, Rigo M, Lebel A, Hennes A, Romano M, Bialek M, M'hango A, Betts T, de Mauroy JC, Durmala J. Physiotherapy scoliosis-specific exercises - a comprehensive review of seven major schools. Scoliosis Spinal Disord. 2016 Aug 4;11:20. doi: 10.1186/s13013-016-0076-9. eCollection 2016.
PubMed 27525315
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Augmented Reality-Based Exercise Training on Body Awareness, Trunk Appearance Perception, and Exercise Adherence in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07201103
- Acronym / sponsor ID
- AR-SCOLIO / 323S271
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Scoliosis, Adolescent Idiopathic Scoliosis, AR-based Rehabilitation, Augmented Reality Exercise Training, Physiotherapeutic Scoliosis-Specific Exercises (PSSE), Schroth Method, Exercise Adherence, Body Awareness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 1 Oct 2025 (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 investigates the effects of augmented reality (AR)-based exercise training in adolescents with idiopathic scoliosis. Participants are randomly assigned to either a control group receiving conventional Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) or an intervention group receiving AR-assisted PSSE-Schroth exercises. The primary outcomes include body awareness, trunk appearance perception, and exercise adherence. The study aims to evaluate whether AR-assisted training provides additional benefits over conventional therapy in improving postural control, perception, and compliance in scoliosis management.
Detailed description
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that may negatively affect posture, body image, and adherence to exercise-based rehabilitation. While Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) are widely accepted as a conservative treatment method, adherence and perception-related factors remain challenging.
This study is designed as a parallel-group, randomized controlled trial comparing conventional PSSE-Schroth exercises with AR-assisted PSSE-Schroth training. A total of 30 adolescents diagnosed with AIS were enrolled and randomized into two groups:
Control Group: received supervised PSSE-Schroth exercises.
Intervention Group: received supervised AR-assisted PSSE-Schroth exercises.
The intervention lasted 12 weeks, and participants were evaluated at baseline and post-intervention.
Primary outcome measures include body awareness (Awareness-Body-Chart), trunk appearance perception (Walter Reed Visual Assessment Scale, Spinal Appearance Questionnaire), and exercise adherence (Exercise Adherence Rating Scale).
Secondary outcome measures include Cobb angle, vertebral rotation, pain intensity, and treatment satisfaction.
The study hypothesizes that AR-assisted PSSE-Schroth training will enhance body awareness, improve trunk appearance perception, and increase adherence compared to conventional methods. This research may provide new insights into integrating digital technologies into scoliosis rehabilitation and contribute to developing innovative, patient-centered approaches in physiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly allocated to either the control group (conventional PSSE-Schroth) or the intervention group (AR-assisted PSSE-Schroth). Both groups received supervised exercise training over 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Control - Conventional PSSE-Schroth | Active comparator | Behavioral: Conventional PSSE-SchrothParticipants in this group received supervised conventional Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) for 4 weeks. The program included one 45-minute supervised session per week, complemented by home exercises. Established scoliosis rehabilitation protocols focusing on posture correction, breathing, and spinal alignment were followed. |
| Experimental - AR-assisted PSSE-Schroth | Experimental | Behavioral: AR-Assisted PSSE-SchrothParticipants in this group received supervised augmented reality (AR)-assisted Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) for 4 weeks. The intervention included one 45-minute supervised session per week, supplemented with home exercises. Augmented reality technology was used to provide real-time visual and kinesthetic feedback, aiming to enhance posture correction, breathing patterns, and spinal alignment. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Adolescents clinically diagnosed with idiopathic scoliosis (AIS)
- Cobb angle between 10° and 30°
- Age range: 10-18 years
- No history of spinal surgery
- Ability to regularly participate in the exercise program
Key exclusion criteria (5 listed)
- Diagnosis of neuromuscular, congenital, or secondary scoliosis
- Previous history of spinal surgery
- Presence of severe cardiovascular, respiratory, or musculoskeletal conditions preventing participation in exercise
- Visual, auditory, or perceptual impairments that would hinder participation in augmented reality-based training
- Concurrent participation in another physiotherapy or rehabilitation program during the study period
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 |
|---|---|---|
| Conventional PSSE-SchrothAlso: Schroth MethodParticipants performed conventional Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) for 4 weeks. The program consisted of one 45-minute supervised session per week complemented by home-based exercises. The exercises focused on posture correction, spinal alignment, and corrective breathing techniques according to standard scoliosis rehabilitation protocols. | Behavioural | Control - Conventional PSSE-Schroth |
| AR-Assisted PSSE-SchrothAlso: Augmented Reality Exercise TrainingParticipants performed Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) enhanced with augmented reality (AR) support for 4 weeks. The intervention included one 45-minute supervised session per week, plus home-based exercises. The AR system provided real-time visual and kinesthetic feedback during exercise sessions to improve body awareness, trunk appearance perception, and adherence. | Behavioural | Experimental - AR-assisted PSSE-Schroth |
Primary outcome
Change in Body Awareness (ABC - Vücut Farkındalık Çizelgesi)
Time frame: Baseline (T0) and 4 weeks after intervention (T4).
Body awareness will be assessed using the standardized Awareness-Body-Chart (ABC). Participants rate awareness of different body regions, and a total score is calculated. The outcome is the change in total ABC score from baseline (T0) to the end of intervention (T4, 4th week). A higher score indicates greater body awareness.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Results publication: PubMed 39964686Yuan W, Shi W, Chen L, Liu D, Lin Y, Li Q, Lu J, Zhang H, Feng Q, Zhang H; Digital Care Study Group. Digital Physiotherapeutic Scoliosis-Specific Exercises for Adolescent Idiopathic Scoliosis: A Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2459929. doi: 10.1001/jamanetworkopen.2024.59929.
- Results publicationCavalcanti, V. C., Ferreira, M. I. d. S., Teichrieb, V., Barioni, R. R., Correia, W. F. M., Da Gama, A. E. F. 2019. "Usability and effects of text, image and audio feedback on exercise correction during augmented reality based motor rehabilitation", Computers & Graphics, 85, 100-10.
- Results publication: PubMed 33857180Kocaman H, Bek N, Kaya MH, Buyukturan B, Yetis M, Buyukturan O. The effectiveness of two different exercise approaches in adolescent idiopathic scoliosis: A single-blind, randomized-controlled trial. PLoS One. 2021 Apr 15;16(4):e0249492. doi: 10.1371/journal.pone.0249492. eCollection 2021.
- Results publication: PubMed 38631273Buyukturan O, Kaya MH, Alkan H, Buyukturan B, Erbahceci F. Comparison of the efficacy of Schroth and Lyon exercise treatment techniques in adolescent idiopathic scoliosis: A randomized controlled, assessor and statistician blinded study. Musculoskelet Sci Pract. 2024 Aug;72:102952. doi: 10.1016/j.msksp.2024.102952. Epub 2024 Apr 12.
- Results publication: PubMed 39062255Chen C, Xu J, Li H. Effects of Schroth 3D Exercise on Adolescent Idiopathic Scoliosis: A Systematic Review and Meta-Analysis. Children (Basel). 2024 Jul 1;11(7):806. doi: 10.3390/children11070806.
- Results publication: PubMed 28033399Schreiber S, Parent EC, Khodayari Moez E, Hedden DM, Hill DL, Moreau M, Lou E, Watkins EM, Southon SC. Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial. PLoS One. 2016 Dec 29;11(12):e0168746. doi: 10.1371/journal.pone.0168746. eCollection 2016.
- Results publication: PubMed 27525315Berdishevsky H, Lebel VA, Bettany-Saltikov J, Rigo M, Lebel A, Hennes A, Romano M, Bialek M, M'hango A, Betts T, de Mauroy JC, Durmala J. Physiotherapy scoliosis-specific exercises - a comprehensive review of seven major schools. Scoliosis Spinal Disord. 2016 Aug 4;11:20. doi: 10.1186/s13013-016-0076-9. eCollection 2016.
- Individual participant dataSharing planned: Undecided. At this stage, the decision on sharing individual participant data (IPD) is undecided. As the study is supported by TÜBİTAK (The Scientific and Technological Research Council of Turkey), any data sharing must comply with the funder's policies, ethical approval requirements, and national data protection regulations. The research team is committed to transparency and is open to sharing de-identified, anonymized data upon reasonable request from qualified researchers. Such sharing will only take place after publication of the study results, and contingent upon TÜBİTAK's approval and the execution of appropriate data-sharing agreements to ensure participant confidentiality and compliance with legal and ethical standards.
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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.
Adnan B Coşkun, PhD principal investigator
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional PSSE-Schroth and AR-Assisted PSSE-Schroth in people with Adolescent Idiopathic Scoliosis, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 1 Oct 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Body Awareness (ABC - Vücut Farkındalık Çizelgesi) (time frame: Baseline (T0) and 4 weeks after intervention (T4).). 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 NCT07201103, which also lists 7 linked publications.
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 Oct 2025.