- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07738588
Wireless EMG-Based Monitoring of Paraspinal Muscle Activation in Adolescent Idiopathic Scoliosis (AIS-EMG)
Design of a Wireless and Non-Invasive EMG-Based Embedded Measurement System for Monitoring Muscle Activation Asymmetries in Scoliosis
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Alpaslan Ersöz, Ph.D
- Telefonnummer: +905312561935
- E-mail: alpaslan.ersoz@amasya.edu.tr
Studiesteder
-
-
Amasya
-
Amasya, Amasya, Tyrkiet (Türkiye), 05100
- Amasya University
-
Underforsker:
- Ertuğrul Deniz Köse, Ph.D
-
Kontakt:
- Alpaslan Ersöz, Ph.D
- Telefonnummer: +905312561935
- E-mail: alpaslan.ersoz@amasya.edu.tr
-
Ledende efterforsker:
- Alpaslan Ersöz, Ph.D
-
Underforsker:
- Eylem Küçük, Ph.D
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Weinstein SL, Dolan LA, Cheng JC, Danielsson A, Morcuende JA. Adolescent idiopathic scoliosis. Lancet. 2008 May 3;371(9623):1527-37. doi: 10.1016/S0140-6736(08)60658-3.
- Liang R, Yip J, Fan Y, Cheung JPY, To KM. Electromyographic Analysis of Paraspinal Muscles of Scoliosis Patients Using Machine Learning Approaches. Int J Environ Res Public Health. 2022 Jan 21;19(3):1177. doi: 10.3390/ijerph19031177.
- Fan Y, To MK, Yeung EHK, Kuang GM, Liang R, Cheung JPY. Electromyographic Discrepancy in Paravertebral Muscle Activity Predicts Early Curve Progression of Untreated Adolescent Idiopathic Scoliosis. Asian Spine J. 2023 Oct;17(5):922-932. doi: 10.31616/asj.2023.0199. Epub 2023 Sep 11.
- Chan WWY, Fu SN, Chong TF, Singh G, Tsai DSJ, Wong MCY, Zheng YP, Parent EC, Cheung JPY, Wong AYL. Associations between paraspinal muscle characteristics and spinal curvature in conservatively treated adolescent idiopathic scoliosis: a systematic review. Spine J. 2024 Apr;24(4):692-720. doi: 10.1016/j.spinee.2023.11.008. Epub 2023 Nov 24.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Amasya Uni-EMG
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .