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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorRomatem Bursa Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

20-60 years old

Female and male

Disqualifiers

muscle disease

stroke

spinal cord injury

history of disc herniation surgery,

Trial design

Design model

Single group

Treatments tested in this trial

  • Needle EMG Recording

    Diagnostic test

    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

  • Adhesive Surface EMG Recording

    Diagnostic test

    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

  • Ag/AgCl Cup Electrode Recording

    Diagnostic test

    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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Healthy Volunteers GroupOther 3 interventions

Trial outcomes

Primary outcomes

1

Assessment of Muscle Activation Patterns: Mean Amplitude and Duration of Motor Unit Action Potentials (MUAPs) measured via Diagnostic EMG

Physiological muscle activity of the M. Tibialis Anterior will be recorded using both needle and surface electrodes. The study will assess and compare two key parameters: the mean amplitude (measured in microvolts) and the mean duration (measured in milliseconds) of the recorded signals. All measurements will be conducted using a diagnostic EMG device to evaluate the correlation between invasive and non-invasive recording techniques during a single one-hour assessment. Each participant will perform the task sequentially using three different electrode systems (M. Tibialis Anterior activation): concentric needle electrodes, adhesive surface electrodes, and Ag/AgCl coated cup electrodes. The entire measurement process for each volunteer is expected to be completed within a single one-hour session. Recruitment will remain active until data from 30 eligible healthy volunteers are successfully collected

Time frame
At baseline (Day 1)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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