Recruiting NA INTERVENTIONAL NCT07556042

Machine learning to predict progression in adolescent idiopathic scoliosis — the aim is not diagnosis but optimizing how often X-rays are taken (NCT07556042)

Istanbul University Updated 2026-08-19

A study developing and validating a machine-learning model to predict the Cobb angle after a 12-week core stabilization exercise programme in adolescent idiopathic scoliosis (AIS). The aim is not diagnosis but reading progression well enough to optimize the frequency of follow-up radiography. Planned enrollment 30.

Trial overview (primary data)

  • StatusRecruiting
  • ConditionsAdolescence Idiopathic Scoliosis
  • InterventionsBEHAVIORAL: Core Stabilization Exercise
  • SponsorIstanbul University
  • Target enrollment30 participants
  • Period2026-04-20 〜 2026-09-12

Key points

  • A study building a machine-learning model retrospectively and validating it prospectively to predict the Cobb angle after 12 weeks of core stabilization exercise.
  • The aim is not diagnosis but predicting progression so that the frequency of follow-up radiography can be optimized.
  • The record notes cumulative radiation from repeated imaging, and that breast cancer risk in girls with AIS is reported to be roughly seven times that of the healthy population.
  • The record states that the inability to predict progression leads to both unnecessary bracing and delayed intervention.
  • Planned enrollment 30. Across the 750 medical-AI trials this site holds as of 2026-08-28, 254 — 34 percent — plan 100 participants or fewer.
  • Repeated radiographs raise lifetime cancer risk through cumulative dose, while longer intervals risk missing the window.

1Not knowing where it goes distorts the treatment

The difficulty in scoliosis lies less in the curve than in the inability to see where it is heading. The record lists what follows from that: bracing for 18 hours a day over years, compliance undermined by appearance, function and skin irritation, and split judgments in cases sitting on the border of surgical indication.

Because progression cannot be read, both patients who wear a brace they did not need and patients whose intervention comes late are produced by the same uncertainty. The value of a correct prediction here is not that it widens the options but that it removes treatment nobody needed.

2The target is imaging frequency, not diagnosis

What this study asks of AI is not to find disease in an image. It is to predict progression so that follow-up radiography can be reduced. The record notes that repeated imaging for monitoring raises lifetime cancer risk through cumulative ionizing radiation, and that the risk of breast cancer in girls with AIS is reported to be roughly seven times that of the healthy population.

Stretch the intervals too far, though, and the window for early intervention is missed. The idea is to ease a bind in which imaging more moves away from safety while imaging less moves toward missed deterioration.

3Trials of 100 or fewer make up a third of the field

Planned enrollment is 30. Across the 750 medical-AI clinical trials this site holds as of 2026-08-28, 25434 percent — plan 100 participants or fewer, against a median of 200. Small studies do not generalize well, but the design itself, building a model retrospectively and validating it prospectively, follows a standard sequence in medical-AI development.

Clinical evaluation of medical AI has a thick layer of small exploratory work, and this study sits in that layer. The performance of the model, and whether the predictions hold, are not part of this registry record.

4The more you image, the further from safety

Follow-up in scoliosis carries a bind. What the study asks of AI is not diagnosis but loosening that bind.

Imaging at shorter intervalsSpacing the intervals out
Progression is caught earlierCumulative dose is limited
Repeated radiographs raise lifetime cancer riskThe chance for early intervention can be lost
Breast cancer risk in girls with scoliosis is reported at about seven times that of healthy peersIt moves closer to missing something

Because progression cannot be read, both patients who keep wearing an unnecessary brace and patients whose intervention comes late are produced. The value of an accurate prediction here is not adding treatment options but removing unnecessary treatment and unnecessary imaging. Thirty participants are planned, with a model built retrospectively and validated prospectively.

Why it matters

The value of a predictive model does not always lie in creating new treatment. Using it, as here, to reduce the number of examinations and ease the bind between radiation exposure and missed deterioration points to a direction easily overlooked when weighing the return on medical AI.

FAQ

Does this AI diagnose scoliosis?
No. The record states the primary aim is a model predicting the Cobb angle after a 12-week exercise intervention. It predicts progression rather than making a diagnosis.
Why is imaging frequency a problem?
The record states that repeated monitoring radiography raises lifetime cancer risk through cumulative radiation, while stretching the intervals too far misses the window for early intervention.
Can 30 participants settle the question?
That size corresponds to an exploratory stage. The design builds a model retrospectively and validates it prospectively, but the performance and results are not part of this registry record.

Sources (primary)

Source: ClinicalTrials.gov (U.S. NIH/NLM, public domain). This site does not provide medical advice. Verify the latest and exact details with the official source. This site is not endorsed or certified by the NIH/NLM.

#Clinical trials#AI#Healthcare#Orthopaedics#Paediatrics
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