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临床试验/NCT06527417
NCT06527417已完成不适用

The Effect of Electromyography Triggered Electrical Stimulation on Trunk Balance and Muscle Thickness of Multifidus and Erector Spinae Muscles in Patients With Complete Spinal Cord Injury - A Randomised Controlled Study

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年8月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Trunk control test

研究概览

简要总结

The aim of this study was to investigate the effect of electromyography (EMG) triggered electrical stimulation (ES) applied to multifidus and erector spinae muscles on trunk balance in patients with complete thoracic spinal cord injury (SCI).

The fundamental questions that investigators want to answer are as follows:

  • [question 1]: "Does multifidus and erector spinae EMG ES improve trunk balance in patients with complete SCI?"
  • [question 2]: "Does multifidus and erector spinae EMG ES improve muscle thickness in patients with complete SCI?"

详细描述

Spinal cord injury results in loss of sensory and motor function below the level of injury, causing difficulty with unaided sitting and activities of daily living, especially at the thoracic level in SCI patients. The paraspinal muscles that provide trunk balance are weakened in these patients. Methods such as neuromuscular electrical stimulation and EMG ES are used to improve trunk balance and restore muscle function. This study aims to investigate the effect of EMG ES applied to the multifidus and erector spinae muscles on trunk balance in patients with complete thoracic SCI.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •have traumatic SCI and this injury occurred at least 3 months ago,
  • •be between the ages of 18 and 65,
  • •have a neurological injury level between thoracic 4 and thoracic 12
  • •be fully paraplegic according to the American Spinal Cord Injury Association (ASIA) impairment scale
  • •be able to sit unsupported in a wheelchair

排除标准

  • •patients with a diagnosis of heart failure
  • •malignancy
  • •intracardiac defibrillators
  • •open wounds
  • •patients using trunk corsets

研究组 & 干预措施

electromyography-triggered electrical stimulation

Experimental

EMG ES was applied to the bilateral multifidus and erector spina muscles of the experimental group 3 times a week for 10 minutes in each session for 4 weeks. At the beginning of each session, the participants were instructed to position themselves in a comfortable sitting position.

EMG ES was performed using six self-adhesive electrodes (37 × 64 mm) and two Neuro Trac Myo Plus Pro devices.

干预措施: Neuro Trac Myo Plus Pro (Device)

trunk eccentric exercises

Active Comparator

The control group performed back eccentric exercises for 4 weeks, 3 times a week, 3 times in each session.

干预措施: Trunk eccentric exercises (Other)

结局指标

主要结局

Trunk control test

时间窗: Baseline- Week 4

The trunk control test is a useful tool in determining the prognosis of independence in activities of daily living and measuring trunk balance in individuals with spinal cord injury. It was applied to all participants before and after treatment. The test consisted of 3 parts; static control, dynamic control and dynamic control with upper extremity activities.

Modified functional reach test

时间窗: Baseline- Week 4

The modified functional reach test is a reliable tool to assess sitting reaching in individuals with SCI and to provide immediate feedback to study personnel. It was applied to both groups before and after treatment.

次要结局

  • Erector spinae muscle thickness(Baseline- Week 4)

研究者

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

Handan Elif Nur BAYRAKTAR

Principal Investigator

Ankara City Hospital Bilkent

研究点 (1)

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