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

27 juli 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • Amasya
      • Amasya, Amasya, Turkiet (Türkiye), 05100
        • Amasya University
        • Underutredare:
          • Ertuğrul Deniz Köse, Ph.D
        • Kontakt:
        • Huvudutredare:
          • Alpaslan Ersöz, Ph.D
        • Underutredare:
          • Eylem Küçük, Ph.D

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Paraspinal Muscle Activation Asymmetry Index
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Correlation Between EMG-Based Muscle Activation Asymmetry Index and Clinical Treatment Outcome (Cobb Angle Change)
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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Publikationer och användbara länkar

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

31 augusti 2027

Avslutad studie (Beräknad)

31 augusti 2028

Studieregistreringsdatum

Först inskickad

22 juli 2026

Först inskickad som uppfyllde QC-kriterierna

27 juli 2026

Första postat (Faktisk)

31 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

31 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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