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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07738588
Acronym
AIS-EMG
Enrollment
100
Registered
2026-07-31
Start date
2026-09-01
Completion date
2028-08-31
Last updated
2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Idiopathic Scoliosis (AIS)

Keywords

Electromyography, Surface EMG, Paraspinal Muscles, Muscle Activation, Wireless Biosensor, Embedded Measurement System, Physiotherapy Monitoring

Brief summary

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.

Detailed description

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.

Interventions

DEVICEWireless Embedded Surface EMG (sEMG) Measurement System

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.

Sponsors

Ertugrul Deniz Kose
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

This is a single-group, non-randomized feasibility study. All enrolled participants (adolescents with idiopathic scoliosis, Cobb angle 10°-25°) will undergo surface EMG monitoring using the study's wireless, embedded measurement system, with no comparison or control group. EMG recordings will be obtained under standardized static and dynamic tasks at baseline and repeated at multiple time points over the course of each participant's physiotherapy treatment, allowing within-subject, longitudinal evaluation of muscle activation asymmetry and its relationship to treatment response. The study is intended to establish technical feasibility and preliminary clinical utility of the measurement system rather than to test comparative treatment efficacy.

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Paraspinal Muscle Activation Asymmetry IndexBaseline and through study completion, an average of 1 yearAn 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.

Secondary

MeasureTime frameDescription
Correlation Between EMG-Based Muscle Activation Asymmetry Index and Clinical Treatment Outcome (Cobb Angle Change)Baseline and through study completion, an average of 1 yearThe 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.
Device Signal Acquisition Success Ratethrough study completion, an average of 1 yearThe 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTAlpaslan Ersöz, Ph.D
alpaslan.ersoz@amasya.edu.tr+905312561935

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026