Assessment Of Signal Consistency Between Needle And Surface Electrodes In Tibialis Anterıor Muscle: A Pilot Validaton Study

NCT07579923 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-20

No results posted yet for this study

Summary

The aim of this study is to evaluate whether surface electrodes can record physiological muscle activity as accurately as the gold-standard needle electrodes in the tibialis anterior muscle using a diagnostic EMG device The aim of this pilot study is to investigate whether muscle activation data, similar to surface electromyography (SEMG), can be obtained by adjusting the measurement and recording parameters of standard Electroneuromyography (EMG) devices used routinely for diagnostic purposes. Although SEMG is considered the gold standard for the objective assessment of muscle activation, its clinical use in our country is limited due to the high cost of specialized hardware and software. In contrast, diagnostic EMG devices are widely available in many healthcare institutions.

The research will be conducted on 30 healthy volunteers between the ages of 20 and 60. Participants will undergo lower extremity nerve conduction studies, reflex response measurements, and muscle activation assessments during voluntary isometric contractions of the m. tibialis anterior. Muscle activation will be recorded using the diagnostic EMG device via surface (adhesive and Ag/AgCl coated) electrodes and needle electrodes. The acquired EMG signals will be analyzed in terms of RMS (Root Mean Square), amplitude, and frequency parameters.

The procedures performed within the scope of this study are standard practices carried out during routine EMG examinations. The only additional procedure specific to this research is the repetition of muscle activation measurements using different electrode systems. There is no invasive procedure involved in the surface electrode applications, and the needle electrode application will be performed exactly as it is in routine EMG tests. No serious risks are anticipated; rarely, mild pain, redness, or minor bleeding at the needle insertion site may occur.

Through this study, diagnostic EMG devices could be utilized more effectively in rehabilitation and treatment monitoring. It is intended to contribute to the reduction of invasive procedures and to establish a scientific foundation for clinical applications regarding the objective evaluation of muscle activation.

Conditions

  • Healthy Volunteers (HV)
  • Muscle Activation
  • Electromyography

Interventions

DIAGNOSTIC_TEST

Needle EMG Recording

A standard concentric needle electrode will be inserted into the M. Tibialis Anterior muscle belly. Physiological motor unit potentials will be recorded using a diagnostic EMG device to assess amplitude and duration

DIAGNOSTIC_TEST

Adhesive Surface EMG Recording

Disposable self-adhesive surface electrodes will be placed on the skin over the motor point of the M. Tibialis Anterior. Muscle electrical activity will be recorded during voluntary contraction using a diagnostic EMG device

DIAGNOSTIC_TEST

Ag/AgCl Cup Electrode Recording

Ag/AgCl coated cup electrodes will be attached to the skin surface of the M. Tibialis Anterior using conductive paste. Muscle signals will be captured to compare with other recording methods

Sponsors & Collaborators

  • Romatem Bursa Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-24
Primary Completion
2026-06-01
Completion
2026-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07579923 on ClinicalTrials.gov