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

July 30, 2024 updated by: Handan Elif Nur BAYRAKTAR, Ankara City Hospital Bilkent

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

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?"

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: electromyography-triggered electrical stimulation

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.
Device: Neuro Trac Myo Plus Pro
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.
Active Comparator: trunk eccentric exercises
The control group performed back eccentric exercises for 4 weeks, 3 times a week, 3 times in each session.
Other: Trunk eccentric exercises
The control group performed back eccentric exercises for 4 weeks, 3 times a week, 3 times in each session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline- Week 4
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.
Baseline- Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline- Week 4

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline- Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2023

Primary Completion (Actual)

February 18, 2024

Study Completion (Actual)

July 25, 2024

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraCHBilkent-PMR-DRHENY-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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