Wireless EMG-Based Monitoring of Paraspinal Muscle Activation in Adolescent Idiopathic Scoliosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorErtugrul Deniz Kose
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with adolescent idiopathic scoliosis
Cobb angle between 10° and 25°
No prior surgical or conservative treatment for scoliosis
Disqualifiers
Neurological disease
Significant concomitant orthopedic problems
Back pain severe enough to interfere with the measurement process
Trial design
Design model
Single group
Treatments tested in this trial
Wireless Embedded Surface EMG (sEMG) Measurement System
DeviceA 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Experimental: Wireless EMG MonitoringExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Paraspinal Muscle Activation Asymmetry Index
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.
Time frame
Baseline and through study completion, an average of 1 yearSecondary outcomes
1
Correlation Between EMG-Based Muscle Activation Asymmetry Index and Clinical Treatment Outcome (Cobb Angle Change)
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.
Time frame
Baseline and through study completion, an average of 1 year2
Device Signal Acquisition Success Rate
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.
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ertugrul Deniz Kose
Lead sponsor
Hitit University
Sponsor institution
Source ClinicalTrials.gov
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