The Effect of Superimposed Electrical Stimulation on Sitting Balance, Respiratory Functions, and Abdominal Muscle Thickness in Complete Spinal Cord Injury

NCT ID: NCT06104982

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-06
• Study Completion Date: 2023-04-11

Brief Summary

The primary aim of the current study was to investigate the effects of SiFES (superimposed functional electrical stimulation) on sitting balance in patients with complete Spinal Cord Injury (SCI) compared to exercise alone. Additionally, the study aims to investigate improvements in respiratory functions and changes in abdominal muscle thickness measured by ultrasonography (USG) following SiFES treatment.

The fundamental questions that investigators want to answer are as follows:

• [question 1]: "Does abdominal SiFES therapy improve sitting balance in patients with complete SCI?"
• [question 2]: "Does abdominal SiFES therapy improve respiratory functions in patients with complete SCI?"

Detailed Description

Many patients with SCI are ambulatory with a wheelchair. Therefore, providing good sitting balance in these patients is a key factor for performing activities of daily living (ADL) and achieving functional independence. Paralysis of abdominal muscles in patients with SCI disrupts body balance. In these patients, problems with trunk balance can lead to frequent falls and poor rehabilitation outcomes. Also, abdominal muscles assist in forceful expiration. Loss of innervation to abdominal and intercostal muscles reduces their ability to excrete secretions and cough effectively. As a result, respiratory tract complications, such as pneumonia, atelectasis, and respiratory failure can arise. It should be noted that in individuals with SCI, respiratory tract complications are the primary cause of morbidity and mortality. Newly used SiFES is a method in which the biofeedback-enabled FES device detects muscle contractions, and this electromyography (EMG) signal triggers the muscle stimulant mode of the device. In this method, more stimuli are conveyed to the brain through afferent nerves, allowing for motor learning to potentially occur by reviving the region represented in the cortex. In the current study, the investigators planned due to the anticipation that the synchronized stimulation of SiFES with function will be effective in patients with SCI injuries who currently have weak contraction abilities. The investigators considering the key role of abdominal muscles in trunk stability, believed that the integrated effect of SiFES is of great importance to patients. In the current randomized controlled and prospective study, the investigators included thirty-four participants with thoracic complete SCI. The investigators divided the participants into two equal groups: one group received SiFES applied to the abdominal muscles, while the control group received therapeutic exercise (TE) only. The investigators administered the interventions three times a week for four weeks. The investigators conducted muscle thickness measurements of bilateral rectus abdominis (RA), obliques externus (OE), obliques internus (OI), and transversus abdominis (TA) muscles using ultrasonography for all participants before and after treatment. Additionally, the investigators applied the modified functional reach test (mFRT), trunk control test (TCT), and pulmonary function test (PFT) to assess the participants.

Conditions

Spinal Cord Injury Thoracic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SiFES group

The investigators applied FES to the abdominal muscles of the SiFES group bilaterally, using 2 units of NeuroTrac MyoPlus Pro single-channel electromyography biofeedback electrotherapy devices. The investigators conducted electrical stimulation for a total of 10 minutes per session, with 5 minutes dedicated to bilateral rectus abdominis (RA) and 5 minutes to bilateral obliques externus (OE), obliques internus (OI), and transversus abdominis (TA) muscles three days a week, a period of four weeks. The investigators triggered the initial contraction of the abdominal muscles by instructing the patient to slightly flex their head before the application of electrical stimulation. During this process, the contraction was detected by the surface EMG present in the FES device, and the abdominal muscles were stimulated with electrical impulses.

Group Type: EXPERIMENTAL

NeuroTrac MyoPlus Pro single-channel electromyography biofeedback electrotherapy devices

Intervention Type: DEVICE

Neuromuscular electrical stimulation (NMES) is applied to intact second motor neurons and target muscles of patients with SCI and provides functional and therapeutic benefits in neurological rehabilitation. Functional electrical stimulation (FES) is a type of NMES that is used for electrical stimulation during exercises such as crunches. Newly used SiFES is a method in which the biofeedback-enabled FES device detects muscle contractions, and this electromyography (EMG) signal triggers the muscle stimulant mode of the device.

Control group (TE group)

The investigators administered isometric strengthening to the TE groups, three days a week, with three sets per session, a period of four weeks.

Group Type: ACTIVE_COMPARATOR

Isometric strengthening exercises

Intervention Type: OTHER

Isometric abdominal strengthening exercises are part of the standard rehabilitation program for individuals with spinal cord injuries.

Interventions

NeuroTrac MyoPlus Pro single-channel electromyography biofeedback electrotherapy devices

Neuromuscular electrical stimulation (NMES) is applied to intact second motor neurons and target muscles of patients with SCI and provides functional and therapeutic benefits in neurological rehabilitation. Functional electrical stimulation (FES) is a type of NMES that is used for electrical stimulation during exercises such as crunches. Newly used SiFES is a method in which the biofeedback-enabled FES device detects muscle contractions, and this electromyography (EMG) signal triggers the muscle stimulant mode of the device.

Intervention Type: DEVICE

Isometric strengthening exercises

Isometric abdominal strengthening exercises are part of the standard rehabilitation program for individuals with spinal cord injuries.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• being between 18-65 years old
• having a minimum of 3 months since the spinal cord injury
• having complete paraplegia according American Spinal Injury Association (ASIA) disorder scale A due to traumatic spinal cord injury
• being able to sit unsupported in a wheelchair

Exclusion Criteria

• malignancy,
• epilepsy, heart failure,
• intracardiac defibrillator (ICD)
• an open wound in the application area

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Handan Elif Nur BAYRAKTAR

Specialist Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Other Identifiers

AnkaraCHBilkent-PMR-DRHENY-01

Identifier Type: -

Identifier Source: org_study_id