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Clinical Trials/NCT06527417
NCT06527417
Completed
Not Applicable

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 site in 1 country15 target enrollmentAugust 18, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injury Thoracic
Sponsor
Ankara City Hospital Bilkent
Enrollment
15
Locations
1
Primary Endpoint
Trunk control test
Status
Completed
Last Updated
last year

Overview

Brief Summary

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?"

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 18, 2023
End Date
July 25, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Handan Elif Nur BAYRAKTAR

Principal Investigator

Ankara City Hospital Bilkent

Eligibility Criteria

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
  • open wounds
  • patients using trunk corsets

Outcomes

Primary Outcomes

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.

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

  • Erector spinae muscle thickness(Baseline- Week 4)

Study Sites (1)

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