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

Not Applicable

Completed

• Conditions: Spinal Cord Injury Thoracic
• Interventions: Device: Neuro Trac Myo Plus Pro; Other: Trunk eccentric exercises

• Registration Number: NCT06527417
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Study Timeline

• Study Start: 2023-08-18
• Primary Completion: 2024-02-18
• Status Verified: 2024-07
• Study Completion: 2024-07-25
• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-30
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electromyography-triggered electrical stimulation	Neuro Trac Myo Plus Pro	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.
trunk eccentric exercises	Trunk eccentric exercises	The control group performed back eccentric exercises for 4 weeks, 3 times a week, 3 times in each session.

Primary Outcome Measures

Name	Time	Method
Trunk control test	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	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 Outcome Measures

Name	Time	Method
Erector spinae muscle thickness	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.

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Turkey