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

Overview

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.

The investigators aim to use EMG (Electromyoneurography) devices, which are routinely used for diagnostic purposes, for treatment follow-up .Surface EMG (SEMG) devices and software, which have been used for the last 20 years particularly to observe muscle activation, are very expensive systems; therefore, their use in our country is very limited. With EMG devices, the investigators can record signals and data from muscles using needle electrodes. Needle EMG is an invasive procedure and must be performed by a specialist physician. Examining muscles with needle electrodes is also a daunting process for the patient. While it is acceptable to perform needle insertion into a few muscles for diagnostic purposes, it is not possible to perform this at certain intervals during long-term rehabilitation treatment. EMG (Electromyoneurography) is a diagnostic device used to measure the functional status of nerves and muscles. Generally, sensory and motor nerve conductions (latency-velocity-amplitude) and reflex responses (F response, H reflex) are measured in the upper and lower extremities. By inserting needles into the muscles to be examined, the images and sounds of the muscles during spontaneous activity and voluntary contraction \[MUP (motor unit potentials) characteristics\] are recorded. It is widely used by clinicians, primarily for diagnostic purposes, when peripheral nerve and neuromuscular diseases are considered. International standards for the detection and interpretation of EMG signals were defined a long time ago. Surface EMG (SEMG) can be defined as a "tool for measuring muscle activation".Developments in neurophysiology, signal processing, and SEMG that began in 1950 gained momentum after 2020.Finding evidence to support rehabilitation and evaluate its effectiveness has long been a discussed challenge.SEMG is not a diagnostic tool or a treatment on its own; it can be an objective assessment tool that contributes to clinical evaluations.SEMG is an objective measurement tool that provides extremely valuable information in neurological rehabilitation. Thanks to SEMG data, it is an important auxiliary technique for treatment planning, decision-making in functional surgery, spasticity assessment, monitoring and evaluating results in neurorehabilitation, making changes in the treatment plan, and ensuring accurate motor relearning. Unfortunately, the accumulation of knowledge and developments collected through research in academic and generally engineering laboratories have not been transferred to clinical routine applications at the same rate.Although used in Northern Europe, the USA, and Canada, its awareness is limited in other countries.Barriers to the transition from scientific knowledge to clinical practice in newly produced devices and methods are divided into four categories: cultural-behavioral patterns, educational, technical, and economic. While experiencing all these barriers in our country, our primary obstacle is the inability to own these devices due to them being economically expensive systems.Since they are not included in healthcare reimbursement systems, it also does not seem possible to find financial support from administrators. Once the device is acquired and in use, the investigators can move to the stage of breaking cultural and educational barriers, such as doctor-physiotherapist training, introducing the system, and explaining the benefits of the application to healthcare professionals, patients, and their relatives. Expected Benefits and Risks Surface EMG systems and software are extremely expensive. SEMG has been accepted as the gold standard in measuring muscle activation. Being able to obtain data similar to SEMG by making changes in the measurement and evaluation settings of the diagnostic EMG devices the investigators use will ensure the effective use of these devices. Expected Benefits at the Participant (Volunteer) Level: Lower extremity nerve conduction studies and muscle activity measurements of individuals participating in the study will be performed. A report of the EMG examination, including graphical and numerical data, will be written and provided to the person. They will obtain a measurement of the functional status of their nerves and muscles. This process, based on volunteerism, will enable individuals to have information about nerve and muscle functions. Expected Benefits at the Clinical Practice Level: Many hospitals in our country have diagnostic EMG devices, and routine nerve conduction studies are performed by EMG technicians under doctor supervision. The invasive muscle examination part performed with needle electrodes is a section that must be performed by a doctor. In peripheral nerve injuries, needle EMG is necessary to follow whether muscles have started working after nerve healing or surgery. In some cases, examining a large number of muscles and repeating the examination at frequent intervals may be requested. This becomes an unpleasant, painful examination for these patients and cannot be performed for individuals with a "fear of blood or needles". If it becomes possible to see that at least the muscles thought to be healthy are working through surface electrodes as a screening test, the number of muscles to be examined with a needle can be minimized. In diseases such as stroke, spinal cord injury, and muscle-joint-tendon injuries, it is important to see the effect of physical therapy and rehabilitation, whether healing occurs, and to what degree which muscles are working. This is important for patient morale, motivation, and compliance with treatment. It aids in revising treatment-exercise plans (arranging parameters like treatment type, duration, and intensity). It helps determine the timing for the patient to return to normal life, work, or sports. In cases of spasticity emerging during the healing process of neurological diseases, it assists in the objective measurement of the degree of spasticity and determining the treatment method (medication, botulinum toxin application, or surgery). If surface electrodes can record muscle activation by changing device settings during routine examinations, the investigators will have used these devices for another purpose. Measuring the degree of muscle activation will be objective evidence and will contribute to other measurement-evaluation methods. Expected Benefits at the Scientific Level: This study will contribute to the limited number of researches conducted in our country on the clinical reflections of the surface EMG concept and fill an important gap in the literature The relationship to be shown between surface EMG systems and diagnostic EMG devices will help better understand the objective reflections of muscle activity measurement in diseases and follow-up. If the data does not turn out to be correlated or equivalent to surface EMG, recommending the use of surface EMG will still contribute to science. Benefits in Terms of Education and Academic Development: This study will support the academic development of researchers. A section involving the analysis of data (frequency, filter settings, sweep speed) will be written as a graduation thesis by Efe ÇALIŞIR at Yeditepe University, Department of Electrical \& Electronics Engineering. Based on the results of this pilot research, it is planned to prepare further research projects and apply for a TÜBİTAK-1001 project. Risks: There is no risk in the procedure to be applied. Adhesive electrodes are self-adhesive, so no additional substance will be used, and they do not contain substances that could cause allergic reactions. Since they are single-use electrodes and will be applied to intact skin, there is no risk of transmission. Ag/AgCl coated cup electrodes will be used by washing and sterilizing, and gel will be used for skin contact. During needle electrode data collection, there will be no risk other than the discomfort created by the needle and minor bleeding at the needle site. Type, Scope, and Design of the Planned Research Clinical research conducted with medical devices: effectiveness. Number of Patients and Volunteers, Their Characteristics, and Justification for Selection 30 healthy volunteers, aged 20-60, male and female, who agree to participate will be selected. Participants will be selected randomly from those who meet the inclusion and exclusion criteria after the procedure is explained. Parameters to be Monitored Procedures with Diagnostic EMG Device: Nerve conduction studies: Tibial and peroneal motor conduction in both lower extremities, bilateral tibial F responses, bilateral tibial H reflex, and bilateral sural sensory conductions. Measurement of M. tibialis anterior motor activation: with adhesive surface electrodes, Ag/AgCl coated cup electrodes, and needle electrodes. Preparation and Measurement Protocol: Preparation: Skin is cleaned with alcohol. Active electrodes are placed on the tibialis anterior muscle belly. Ground electrode is placed on the kneecap or ankle. Position: Sitting or lying supine, knee at 90° flexion, foot free. Warm-up: 2-3 submaximal contractions (50-70% intensity, 3-5 seconds). Muscle Measurement: 10-second Maximal Voluntary Isometric Contractions (MVIC). 3 repetitions will be performed with a 3-minute rest between each to prevent fatigue. Data Analysis: Signals will be recorded with a 2000 Hz sampling frequency. A 20-450 Hz band-pass and 50 Hz notch filter will be applied. Data will be analyzed in MATLAB. Procedure Duration Warm-up/Practice 5 minutes Maximum Voluntary Contraction - 1 10 seconds Rest - 1 3 minutes Maximum Voluntary Contraction - 2 10 seconds Rest - 2 3 minutes Maximum Voluntary Contraction - 3 10 seconds Total Duration \~12-15 minutes Where and by Whom Parameters Will Be Monitored Measurements will be taken at the Romatem Bursa Physical Therapy and Rehabilitation Hospital, Neurology polyclinic. All EMG studies will be performed by Neurology Specialist Dr. Nermin ÇALIŞIR. Assistant researchers Phys. İsmail HACIOĞLU and Phys. Beyza Nur TEFENLİ will assist. Signals will be recorded and analyzed by Electrical-Electronics Engineering student Efe ÇALIŞIR. Routine vs. Research-Specific Parameters The applications are routine procedures for an EMG test. The only additional action for research is repeating the same movement 3 more times with 3 different electrode systems. Predicted Study Duration 4 months: 01.02.2026 - 01.06.2026 (To start after ethics committee approval). Inclusion, Exclusion, and Withdrawal Criteria Inclusion: Ages 20-60, male and female, no muscle disease or polyneuropathy. Exclusion: Presence of muscle disease, stroke, spinal cord injury, history of disc herniation surgery, polyneuropathy-causing diseases (DM, thyroid, etc.), professional athletes. Withdrawal: If a neurological disease is detected during the EMG study. Termination Criteria Volunteer recruitment will end after data for 30 volunteers is obtained. Statistical Methods Data will be analyzed using SPSS Statistics 22.0.Normality will be tested with Kolmogorov-Smirnov.Independent sample t-test or Mann-Whitney U test will be used for inter-group comparisons.Paired sample t-test or Wilcoxon test will be used for intra-group comparisons.Significance level is p \< 0.05. Confidentiality and Data Storage No personal identifiers will be collected.Data will be recorded in Case Report Forms using patient numbers.Files will be stored in a locked cabinet in Dr. Nermin ÇALIŞIR's office. Medical Device Information: Device: Deymed TruTrace EMG. Classification: CE 1015: Class IIa. Manufacturer: Deymed Diagnostic s.r.o., Czech Republic. Research Team: Principal Investigator: Assoc. Prof. Meral SEFEROĞLU (University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital). Assistant Researchers: Uzm. Dr. Nermin ÇALIŞIR, Phys. İsmail HACIOĞLU, Phys. Beyza Nur TEFENLİ, Efe ÇALIŞIR.