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NCT Number: NCT06527417

Electromyography-Triggered Electrical Stimulation on Trunk Balance and Muscle Thickness in SCI Patients

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?"

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Key information

Conditions

Spinal Cord Injury Thoracic Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Neuro Trac Myo Plus Pro

Device

Electrical stimulation parameters; stimuli were monophasic, rectangular, stimulus duration 300 µs, frequency 25 Hertz, amplitude was increased up to a maximum of 100 milliampere until contraction was seen.

Trunk eccentric exercises

Other

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

Primary outcomes

  1. Trunk control test

    Time frame: 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.

  2. Modified functional reach test

    Time frame: 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.

Secondary outcomes

  1. Erector spinae muscle thickness

    Time frame: Baseline- Week 4

    Erector spinae muscle thickness was measured with a real-time B-mode ultrasound device (General Electric Co., Wisconsin, USA). Measurements were performed bilaterally in the prone position with an 8-12 MegaHertz linear probe placed parallel to the muscle fibres. Gel was used between the probe and the skin during the measurements. The measurement site was defined as 7 cm lateral to the L3 spinous process of the lumbar erector spina muscle.

Other outcomes

  1. Multifidus muscle thickness

    Time frame: Baseline- Week 4

    Multifidus muscle thickness was measured with a real-time B-mode ultrasound device (GE, General Electric Co., Wisconsin, USA). Measurements were performed bilaterally in the prone position with an 8-12 MegaHertz linear probe placed parallel to the muscle fibres. Gel was used between the probe and the skin during the measurements. The measurement site was defined as 2 cm lateral to the L4 spinous process of the Multifidus muscle.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 30, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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