Clinical trial NCT06527417: Electromyography-Triggered Electrical Stimulation on Trunk Balance and Muscle Thickness in SCI Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury Thoracic
Keywords: spinal cord injury
trunk balance
electrical stimulation
multifidus
erector spinae
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this randomized controlled and prospective study, investigators included 15 participants with complete thoracic spinal cord injury. Investigators divided the participants into two groups, where one group received the electromyography-triggered electrical stimulation applied to the erector spinae and multifidus muscles, and the control group received trunk eccentric exercises only, applied three times a week for four weeks.
Primary purpose: TREATMENT

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.

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
* epilepsy
* open wounds
* patients using trunk corsets

Primary outcomes:
measure: Trunk control test
timeFrame: Baseline- Week 4
measure: Modified functional reach test
timeFrame: Baseline- Week 4
Secondary outcomes:
measure: Erector spinae muscle thickness
timeFrame: Baseline- Week 4
Other outcomes:
measure: Multifidus muscle thickness
timeFrame: Baseline- Week 4
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
References:
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