Assessment Of Signal Consistency Between Needle And Surface Electrodes In Tibialis Anterıor Muscle: A Pilot Validaton Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Assessment of Muscle Activation Patterns: Mean Amplitude and Duration of Motor Unit Action Potentials (MUAPs) measured via Diagnostic EMG
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20-60 years old
- •Female and male
排除标准
- •muscle disease
- •spinal cord injury
- •history of disc herniation surgery,
- •polyneuropathy-causing diseases (DM, thyroid, etc.)
- •professional athletes
研究组 & 干预措施
Healthy Volunteers Group
A single group of 30 healthy volunteers receiving sequential/simultaneous EMG recordings using three different electrode types (needle, adhesive surface, and Ag/AgCl cup)
干预措施: Adhesive Surface EMG Recording (Diagnostic Test)
Healthy Volunteers Group
A single group of 30 healthy volunteers receiving sequential/simultaneous EMG recordings using three different electrode types (needle, adhesive surface, and Ag/AgCl cup)
干预措施: Needle EMG Recording (Diagnostic Test)
Healthy Volunteers Group
A single group of 30 healthy volunteers receiving sequential/simultaneous EMG recordings using three different electrode types (needle, adhesive surface, and Ag/AgCl cup)
干预措施: Ag/AgCl Cup Electrode Recording (Diagnostic Test)
结局指标
主要结局
Assessment of Muscle Activation Patterns: Mean Amplitude and Duration of Motor Unit Action Potentials (MUAPs) measured via Diagnostic EMG
时间窗: At baseline (Day 1)
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
次要结局
未报告次要终点
研究者
Nermin Çalışır
Medical Doctor
Romatem Bursa Hospital