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Deep Learning for Early Scoliosis Detection Using mmWave Radar Gait Data (ScoliRadar-AI)

12 de maio de 2026 atualizado por: Zehra Bilici, Gebze Technical University

A Deep Learning-Based Approach for Early Scoliosis Detection Using mmWave Radar-Based Gait Data

Scoliosis is a sideways curvature of the spine that often develops during childhood and adolescence. When detected early, scoliosis can be managed effectively with non-invasive approaches such as bracing and physiotherapy, while late detection frequently leads to surgical intervention. Current screening methods rely on physical examination and X-ray imaging, which exposes children to ionizing radiation and may miss early-stage cases.

This observational study investigates whether millimeter-wave (mmWave) radar, combined with deep learning (a type of artificial intelligence), can detect early signs of scoliosis by analyzing how a child walks. The radar sensor records subtle movement patterns during walking without using cameras and without producing any identifiable images, fully preserving the participant's privacy. No ionizing radiation is involved.

Pediatric participants attending the orthopedic clinic for routine scoliosis evaluation are invited to walk a short distance in front of a mmWave radar sensor. The collected gait recordings are then analyzed using deep learning models, and the results are compared with the participant's standard clinical scoliosis assessment performed by a pediatric orthopedic specialist. The diagnostic performance of the deep learning model is evaluated using sensitivity, specificity, and overall accuracy.

If the approach proves accurate, it could offer a radiation-free, privacy-preserving, and low-cost alternative for early scoliosis screening in schools, primary healthcare centers, and pediatric orthopedic clinics, ultimately supporting earlier diagnosis and reducing the long-term clinical burden of untreated scoliosis.

Visão geral do estudo

Status

Ainda não está recrutando

Descrição detalhada

Background:

Adolescent Idiopathic Scoliosis (AIS) is the most common form of spinal deformity in children, affecting approximately 2-4% of adolescents worldwide. Early detection is critical because mild curves can often be managed conservatively (bracing, targeted physiotherapy), whereas advanced curves frequently require surgical correction. Current screening primarily relies on physical examination (forward bend test, scoliometer) supplemented by radiographic confirmation. These methods have known limitations: physical examination has variable sensitivity and inter-observer reliability, while repeated radiographic follow-up exposes pediatric patients to cumulative ionizing radiation. Camera-based motion analysis systems have been proposed as alternatives but raise significant privacy concerns in pediatric populations.

Rationale:

Millimeter-wave (mmWave) radar is a non-ionizing, contactless sensing technology that captures fine-grained motion signatures without producing identifiable visual images. Recent advances in deep learning have demonstrated promising results in interpreting radar-derived gait signals for biomechanical analysis. The investigators hypothesize that subtle biomechanical asymmetries associated with early scoliosis can be detected from mmWave radar gait recordings using appropriately trained deep learning models, providing a privacy-preserving and radiation-free screening modality.

Primary Objective:

To develop and evaluate the diagnostic accuracy of a deep learning model that classifies pediatric participants as having scoliosis or not based on mmWave radar gait data, measured by sensitivity, specificity, and area under the receiver operating characteristic curve (AUC-ROC).

Secondary Objectives:

  1. To compare diagnostic performance across multiple deep learning architectures (including convolutional neural networks, recurrent neural networks, and transformer-based models).
  2. To evaluate model performance stratified by age, sex, and curve severity (Cobb angle category).
  3. To assess test-retest reliability of radar-derived gait features.

Study Design:

This is a single-center, prospective, observational diagnostic accuracy study. Pediatric participants undergoing routine scoliosis evaluation at the participating center are invited to take part. Each participant performs a standardized walking task along a defined path in front of a mmWave radar sensor. Radar recordings are processed and analyzed using deep learning models. Model outputs are compared against the reference standard.

Reference Standard:

Scoliosis status is established by a pediatric orthopedic specialist based on clinical examination supplemented by Cobb angle measurement from existing standard-of-care radiographic data. No additional radiographic imaging is performed for the purpose of this study.

Data Handling and Privacy:

All radar recordings and clinical data are de-identified at the point of collection and stored on institutional servers in compliance with the Turkish Personal Data Protection Law (Law No. 6698, KVKK) and the Regulation on Personal Health Data. Data access is restricted to authorized study personnel. No identifiable visual images are recorded by the mmWave radar sensor.

Tipo de estudo

Observacional

Inscrição (Estimado)

200

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

  • Nome: Ercan Ayaz, Doç Dr.

Locais de estudo

    • Istanbul
      • Istanbul, Istanbul, Turquia (Türkiye), 34480
        • Başakşehir Çam and Sakura City Hospital
        • Contato:
        • Contato:
          • Ercan Ayaz, Doç. Dr.

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

Pediatric and adolescent participants attending the pediatric orthopedic outpatient clinic at Başakşehir Çam and Sakura City Hospital for routine scoliosis evaluation. Consecutive eligible patients are invited to participate, including both those with confirmed scoliosis and those in whom scoliosis is ruled out following clinical and radiographic assessment.

Descrição

Participation Criteria:

  • Being between 2 and 75 years of age at the time of registration
  • Having applied to the pediatric orthopedics outpatient clinic for an assessment of suspected or known scoliosis
  • Being able to walk independently for at least 7 meters without assistive devices
  • Written informed consent from a parent or legal guardian
  • Written informed consent from the participant

Exclusion Criteria:

  • Severe scoliosis requiring urgent surgical intervention that prevents participation in walking tasks
  • Refusal to give informed consent or consent

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Pediatric Participants Undergoing Scoliosis Evaluation
Consecutive pediatric participants attending the orthopedic outpatient clinic for routine scoliosis evaluation. The cohort includes participants across the full spectrum of clinical assessment outcomes (both scoliosis confirmed and scoliosis ruled out) to enable evaluation of the diagnostic accuracy of the mmWave radar-based deep learning model against the standard-of-care clinical and radiographic reference assessment.
Each participant performs a standardized walking task along a defined path in front of a millimeter-wave (mmWave) radar sensor. The radar continuously records the participant's gait micro-Doppler signatures during the walk. The mmWave radar device is contactless, non-ionizing, and does not capture identifiable visual images, fully preserving participant privacy. The recorded gait signals are subsequently processed and analyzed using deep learning models (including convolutional and transformer-based architectures) trained to classify scoliosis status. The full radar-based assessment takes approximately 5 to 10 minutes per participant. The standard clinical and radiographic scoliosis evaluation performed as part of routine care serves as the reference standard.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Diagnostic Accuracy of the mmWave Radar-Based Deep Learning Model for Scoliosis Detection (AUC-ROC)
Prazo: Assessed at the end of the data collection period, approximately 18 months after study start
The diagnostic performance of the mmWave radar-based deep learning classification model is assessed by the area under the receiver operating characteristic curve (AUC-ROC). The AUC-ROC is computed by comparing the model's predicted probability of scoliosis for each participant against the reference standard (clinical examination combined with Cobb angle measurement from standard-of-care radiographic imaging) on a held-out test set. The AUC-ROC is reported as a single numeric value between 0 and 1, with 95% confidence intervals.
Assessed at the end of the data collection period, approximately 18 months after study start

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Sensitivity and Specificity of the Deep Learning Model at the Optimal Operating Point
Prazo: Assessed at the end of the data collection period, approximately 18 months after study start
At the operating point that maximizes the Youden index on the validation set, the sensitivity (true positive rate) and specificity (true negative rate) of the deep learning model for classifying scoliosis status are calculated on the held-out test set. Both metrics are reported as percentages with 95% confidence intervals.
Assessed at the end of the data collection period, approximately 18 months after study start
Comparative Diagnostic Performance Across Deep Learning Architectures
Prazo: Assessed at the end of the data collection period, approximately 18 months after study start
The diagnostic accuracy (AUC-ROC) of multiple deep learning architectures, including convolutional neural networks (CNN), recurrent neural networks (RNN/LSTM), and transformer-based models, is compared on the same dataset using cross-validation. The architecture yielding the highest AUC-ROC is identified as the best-performing model.
Assessed at the end of the data collection period, approximately 18 months after study start
Stratified Diagnostic Performance by Scoliosis Severity (Cobb Angle Category)
Prazo: Assessed at the end of the data collection period, approximately 18 months after study start
The diagnostic accuracy of the deep learning model is evaluated separately for participants with mild scoliosis (Cobb angle 10 to 24 degrees), moderate scoliosis (Cobb angle 25 to 39 degrees), and severe scoliosis (Cobb angle 40 degrees or greater). Sensitivity is reported for each severity category to assess whether the model detects clinically significant curves of different magnitudes.
Assessed at the end of the data collection period, approximately 18 months after study start

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2027

Conclusão do estudo (Estimado)

1 de junho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

12 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de maio de 2026

Primeira postagem (Real)

18 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be shared. The dataset consists of biometric gait signatures from minors, classified as personal health data under the Turkish Personal Data Protection Law (Law No. 6698, KVKK) and the Regulation on Personal Health Data. Sharing is restricted by national legislation and institutional policy. De-identified aggregated results will be published in peer-reviewed scientific journals.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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