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

27. juli 2026 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Amasya
      • Amasya, Amasya, Tyrkia (Türkiye), 05100
        • Amasya University
        • Underetterforsker:
          • Ertuğrul Deniz Köse, Ph.D
        • Ta kontakt med:
        • Hovedetterforsker:
          • Alpaslan Ersöz, Ph.D
        • Underetterforsker:
          • Eylem Küçük, Ph.D

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Paraspinal Muscle Activation Asymmetry Index
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Correlation Between EMG-Based Muscle Activation Asymmetry Index and Clinical Treatment Outcome (Cobb Angle Change)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

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Publikasjoner og nyttige lenker

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

31. august 2027

Studiet fullført (Antatt)

31. august 2028

Datoer for studieregistrering

Først innsendt

22. juli 2026

Først innsendt som oppfylte QC-kriteriene

27. juli 2026

Først lagt ut (Faktiske)

31. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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