Deep Learning for Early Scoliosis Detection Using mmWave Radar Gait Data (ScoliRadar-AI)
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.
調査の概要
詳細な説明
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:
- To compare diagnostic performance across multiple deep learning architectures (including convolutional neural networks, recurrent neural networks, and transformer-based models).
- To evaluate model performance stratified by age, sex, and curve severity (Cobb angle category).
- 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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Zehra Bilici, MSc
- 電話番号：+905343056166
- メール：zbilici@gtu.edu.tr
研究連絡先のバックアップ
- 名前：Ercan Ayaz, Doç Dr.
研究場所
-
-
Istanbul
-
Istanbul、Istanbul、トルコ（Türkiye）、34480
- Başakşehir Çam and Sakura City Hospital
-
コンタクト：
- Zehra Bilici, MSc
- 電話番号：05343056166
- メール：zbilici@gtu.edu.tr
-
コンタクト：
- Ercan Ayaz, Doç. Dr.
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic Accuracy of the mmWave Radar-Based Deep Learning Model for Scoliosis Detection (AUC-ROC)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sensitivity and Specificity of the Deep Learning Model at the Optimal Operating Point
時間枠：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
時間枠：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)
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- GTU-Scoliosis-mmWave-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。