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

NCT07738588 | Not Yet Recruiting DMC

• 1 other identifier: Amasya Uni-EMG
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis (AIS)

Keywords

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

Outcome Measures

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.

  Baseline and through study completion, an average of 1 year

Secondary Outcomes (2)

• Correlation Between EMG-Based Muscle Activation Asymmetry Index and Clinical Treatment Outcome (Cobb Angle Change)

  Baseline and through study completion, an average of 1 year

• Device Signal Acquisition Success Rate

  through study completion, an average of 1 year

Study Arms (1)

Experimental: Wireless EMG Monitoring

EXPERIMENTAL

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.

Device: Wireless Embedded Surface EMG (sEMG) Measurement System

Interventions

Wireless Embedded Surface EMG (sEMG) Measurement System DEVICE

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.

Experimental: Wireless EMG Monitoring

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with adolescent idiopathic scoliosis
• Cobb angle between 10° and 25°
• No prior surgical or conservative treatment for scoliosis

You may not qualify if:

• Neurological disease
• Significant concomitant orthopedic problems
• Back pain severe enough to interfere with the measurement process

Sponsors & Collaborators

• Ertugrul Deniz Kose: lead

Study Sites (1)

Amasya University

Amasya, Amasya, 05100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 18456103 BACKGROUND

• 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.

  PMID: 35162203 BACKGROUND

• 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.

  PMID: 37690987 BACKGROUND

• 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.

  PMID: 38008187 BACKGROUND

Central Study Contacts

Alpaslan Ersöz, Ph.D

CONTACT

+905312561935; alpaslan.ersoz@amasya.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)