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临床试验/NCT06516770
NCT06516770进行中(未招募)不适用

The Effects of Different Types of Stimulation on Movement Control and Motor Unit Behavior in Individuals With Lumbopelvic Movement Control Impairment

Mahidol University1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
136
试验地点
1
主要终点
Segmental angular velocity in degrees/second

研究概览

简要总结

This study aims to determine the effect of different stimulations including 1) transcranial direct current stimulation (tDCS), 2) neuromuscular electrical stimulation (NMES), 3) motor control exercise (MCE), and 4) isometric exercise (IE) on movement control and motor unit behavior in individuals with movement control impairment, and determine the correlation between movement control and motor unit behavior.

详细描述

After obtaining the written informed consent, all participants will fill out the information sheet for demographic data. Data collection will be conducted in private laboratory with closed environment. Only lab staffs can access to the lab. Female researchers will perform participant preparation. Participants will be informed that they have to change their cloth to lab tank top to expose their lower back area. However, they can decline to change their cloth. In this case, researchers will fold their cloth to expose the lower back. The body landmarks will be identified. These landmarks include 1) spinous processes (L1 and S1 levels), 2) lumbar multifidus (LM) (2 cm lateral to lower half of L4 spinous process), 3) bilateral lateral epicondyle of femur, and 4) bilateral lateral malleolus. Spinous process of L1, S2, bilateral lateral epicondyle of femur, and bilateral lateral malleolus will be used as locations for inertial measurement unit (IMU) sensors, while LM location will be used to place surface electrode for decomposition electromyography (dEMG). This preparation process will take about 20 minutes.

The participant will be asked to perform 1-minute active forward bend based on speed and load that can differentiate between healthy individuals and individuals with movement control impairment. IMU and dEMG data are concurrently collected. Five-minute rest will be provided to avoid muscle fatigue. After that, participant will be randomly assigned to one of four stimulations including transcranial direct current stimulation (tDCS), neuromuscular electrical stimulation (NMES), isometric exercise (IE), and motor control exercise (MCE). Each stimulation will take approximately 20 minutes.

Types of stimulation Transcranial direct current stimulation (tDCS): The participant will receive the tDCS using 5X7 cm electrodes. The anodal electrode will be placed on M1 representing the back muscles (1 cm anterior and 4 cm lateral to the vertex), while cathodal electrode will be placed on contralateral supraorbital area. The intensity will be set at 2 mA with 10-second fade in/out. The subject will be stimulated by tDCS for 20 minutes.

Neuromuscular electrical stimulation (NMES): The participants will receive the NMES using interferential mode (6000 Hz, beat frequency 20-50 Hz, scanning effect) on bilateral LM. The intensity will be set at the subject's maximum tolerance. Stimulation will be set at 10 seconds on and 60 seconds off to minimize muscle fatigue. The total NMES time is 20 minutes.

Isometric exercise (IE): The participant will be instructed to perform isometric back extension exercise in modified Sorensen position. The participant will hold 60 seconds in neutral position for 5 repetitions with 3 minutes rest between repetitions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Between the ages of 18 and 40
  • •Both male and female
  • •Presence of movement control impairment (instability catch during clinical observation of active forward bend test)
  • •No current episode of low back pain
  • •No definitive neurologic signs including weakness or numbness in the lower extremity
  • •No previous spinal surgery
  • •Have not been diagnosed osteoporosis, severe spinal stenosis, inflammatory joint disease, and/or systemic disease
  • •Body mass index (BMI) less than 30 kg/m2

排除标准

  • •Any lower extremity condition that would potentially alter trunk movement in standing
  • •Vestibular dysfunction
  • •Extreme psychosocial involvement
  • •Active treatment of another medical illness that would preclude participation in any aspect of the study
  • •Contraindication for tDCS including a history of head injury/surgery, seizure, cardiac pacemaker, metal/electrical/magnetic implantation, uncontrolled migraine headache

研究组 & 干预措施

Motor control exercise

Experimental

The subject will receive motor control exercise for 20 minutes.

干预措施: Motor control exercise (Other)

Transcranial direct current stimulation

Experimental

The subject will receive transcranial direct current stimulation for 20 minutes.

干预措施: Transcranial direct current stimulation (Device)

Neuromuscular electrical stimulation

Experimental

The subject will receive neuromuscular electrical stimulation for 20 minutes.

干预措施: Neuromuscular electrical stimulation (Device)

Isometric exercise

Active Comparator

The subject will receive isometric exercise for 20 minutes.

干预措施: Isometric exercise (Other)

结局指标

主要结局

Segmental angular velocity in degrees/second

时间窗: baseline and immediately after the intervention

Segmental angular velocity will be derived from the inertial measurement units.

Number of motor units

时间窗: baseline and immediately after the intervention

Number of motor units will be derived from decomposition of muscle activity using electromyography system.

Motor unit firing rate in pulses/second

时间窗: baseline and immediately after the intervention

Motor unit firing rate will be derived from decomposition of muscle activity using electromyography system.

Clinical observation

时间窗: baseline and immediately after the intervention

Clinical observation rating will be recorded as presence or absence of aberrant movement by two raters.

Motor unit action potential in millivolts

时间窗: baseline and immediately after the intervention

Motor unit action potential will be derived from decomposition of muscle activity using electromyography system.

次要结局

  • Pain intensity(baseline)
  • Level of disability in percentage(baseline)
  • Fear of movement level(baseline)
  • Perception of change(immediately after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peemongkon Wattananon

Associate Professor

Mahidol University

研究点 (1)

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