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Wireless EMG-Based Monitoring of Paraspinal Muscle Activation in Adolescent Idiopathic Scoliosis (AIS-EMG)

2026年7月27日 更新者:Ertugrul Deniz Kose

Design of a Wireless and Non-Invasive EMG-Based Embedded Measurement System for Monitoring Muscle Activation Asymmetries in Scoliosis

This study aims to develop and evaluate a wireless, non-invasive, embedded electromyography (EMG) system for monitoring paraspinal muscle activation asymmetries in adolescents with idiopathic scoliosis. Surface EMG electrodes will be placed bilaterally around the apical vertebra of the spinal curve to record muscle activity during static (seated) and dynamic (trunk extension) tasks. Measurements will be taken longitudinally over the course of physiotherapy treatment to evaluate whether the recorded muscle activity patterns can serve as an objective, non-invasive indicator of treatment response, potentially reducing reliance on repeated radiographic (X-ray) follow-up.

調査の概要

詳細な説明

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity typically diagnosed and monitored through radiographic assessment of the Cobb angle. While imaging remains the clinical gold standard, it involves radiation exposure and is typically performed at limited intervals, making it less suitable for frequent, short-term monitoring of treatment response. Prior research has shown that paraspinal muscle activation asymmetries - particularly increased convex-side activation near the apex of the curve - are consistently observed in AIS and may serve as early, objective markers of curve progression and treatment response, as demonstrated in prospective cohort and machine-learning-based studies.

This study will use a custom-developed, low-power, wireless, embedded surface EMG (sEMG) measurement system, consisting of skin-surface EMG electrodes, an analog front-end (AFE) for signal conditioning and digitization, and a microcontroller-based wireless communication module. EMG signals will be sampled at a minimum of 1000 Hz using a differential (bipolar) electrode configuration to minimize noise and common-mode interference.

Electrodes will be placed bilaterally on the paraspinal muscles at the level of the apical vertebra of the major spinal curve, approximately 3 cm lateral to the spinous process, oriented parallel to the muscle fibers. Standard skin preparation procedures (shaving, alcohol cleaning) will be used to reduce skin impedance prior to electrode placement.

EMG recordings will be performed under two task conditions: a static task, in which participants sit upright with hips and knees flexed at 90°, arms at their sides, and feet on the floor; and a dynamic task, in which participants perform active trunk extension in the prone position for a defined number of repetitions. These tasks are designed to capture both static postural and dynamic movement-related muscle activation patterns.

Recorded EMG signals will be processed to calculate root mean square (RMS) and mean absolute value (MAV) parameters, with frequency-domain (FFT) analysis performed as needed. Convex- and concave-side RMS values at each vertebral level will be used to derive muscle activation ratios and asymmetry indices. Measurements will be repeated at different time points over the course of physiotherapy treatment to evaluate longitudinal changes in muscle activation patterns, and associations between EMG-based indices and clinical treatment outcomes will be examined using appropriate statistical methods.

The study is being conducted in two phases: an initial technical validation phase, in which system performance is verified using commercial EMG sensor evaluation boards and microcontroller-based development platforms; and a subsequent phase in which a custom-designed wireless sEMG system (incorporating a proprietary analog front-end and embedded control unit) is evaluated for feasibility and usability in monitoring muscle activation patterns in scoliosis patients during physiotherapy. Only the human-subjects (clinical) component of this work is registered here; the underlying hardware/firmware engineering and bench validation are not within the scope of this trial record.

研究の種類

介入

入学 (推定)

100

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Amasya
      • Amasya、Amasya、トルコ(Türkiye)、05100
        • Amasya University
        • 副調査官:
          • Ertuğrul Deniz Köse, Ph.D
        • コンタクト:
        • 主任研究者:
          • Alpaslan Ersöz, Ph.D
        • 副調査官:
          • Eylem Küçük, Ph.D

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Diagnosed with adolescent idiopathic scoliosis
  • Cobb angle between 10° and 25°
  • No prior surgical or conservative treatment for scoliosis

Exclusion Criteria:

  • Neurological disease
  • Significant concomitant orthopedic problems
  • Back pain severe enough to interfere with the measurement process

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:診断
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Experimental: Wireless EMG Monitoring
All enrolled participants (adolescents with idiopathic scoliosis, Cobb angle 10°-25°) will undergo surface EMG monitoring using the study's custom-developed wireless, embedded measurement system. Bilateral paraspinal EMG recordings will be obtained at the level of the apical vertebra during standardized static (seated) and dynamic (prone trunk extension) tasks. Measurements will be repeated at multiple time points over the course of each participant's physiotherapy treatment to longitudinally assess muscle activation asymmetry.
A custom-developed, low-power, wireless, non-invasive surface EMG system consisting of skin-surface electrodes, an analog front-end (AFE) for signal conditioning and digitization, and a microcontroller-based wireless communication module. Electrodes are placed bilaterally on the paraspinal muscles at the apical vertebra level, approximately 3 cm lateral to the spinous process. EMG signals are sampled at ≥1000 Hz using a differential (bipolar) configuration and analyzed for root mean square (RMS), mean absolute value (MAV), and frequency-domain (FFT) parameters to quantify muscle activation asymmetry between the convex and concave sides of the spinal curve.

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
Change in Paraspinal Muscle Activation Asymmetry Index
時間枠:Baseline and through study completion, an average of 1 year
An asymmetry index will be calculated from bilateral surface EMG RMS (root mean square) values recorded at the apical vertebra level during static and dynamic tasks, comparing convex- and concave-side paraspinal muscle activation. Change in this index over the course of treatment will be evaluated.
Baseline and through study completion, an average of 1 year

二次結果の測定

結果測定
メジャーの説明
時間枠
Correlation Between EMG-Based Muscle Activation Asymmetry Index and Clinical Treatment Outcome (Cobb Angle Change)
時間枠:Baseline and through study completion, an average of 1 year
The relationship between change in EMG-derived muscle activation asymmetry and change in Cobb angle (measured via standard clinical radiography) will be evaluated using appropriate correlation analysis.
Baseline and through study completion, an average of 1 year
Device Signal Acquisition Success Rate
時間枠:through study completion, an average of 1 year
The proportion of EMG recording sessions in which signal quality meets predefined criteria for analysis (e.g., acceptable signal-to-noise ratio, no excessive artifact), assessing the technical feasibility of the wireless embedded measurement system in a clinical setting.
through study completion, an average of 1 year

協力者と研究者

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出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2027年8月31日

研究の完了 (推定)

2028年8月31日

試験登録日

最初に提出

2026年7月22日

QC基準を満たした最初の提出物

2026年7月27日

最初の投稿 (実際)

2026年7月31日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月31日

QC基準を満たした最後の更新が送信されました

2026年7月27日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

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?

いいえ

IPD プランの説明

Individual participant data will not be shared. EMG recordings, clinical assessment data (including Cobb angle measurements), and other study data will be stored securely and will be accessible only to the research team. Personal identifying information will be kept separate from the analysis dataset. Study findings will be reported in aggregate form in scientific publications, without disclosing any individual participant's identity or raw data.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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