Clinical trial NCT06104982: The Effect of Superimposed Electrical Stimulation on Sitting Balance, Respiratory Functions, and Abdominal Muscle Thickness in Complete Spinal Cord Injury
Official title: The Effect of Superimposed Electrical Stimulation on Sitting Balance, Respiratory Functions, and Abdominal Muscle Thickness in Complete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury Thoracic
Keywords: spinal cord injury
abdominal muscle
electrical stimulation
sitting balance
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 34
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: Investigators included thirty-four participants with thoracic complete SCI in this randomized controlled and prospective study. Investigators divided the participants into two equal groups, where one group received the biofeedback triggered superimposed functional electrical stimulation (SiFES) applied to the abdominal muscles, and the control group received transcutaneous electrical stimulation (TE) only, applied three times a week for four weeks.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Modified Functional Reach Test (mFRT) (reaching of forward, right, left)
timeFrame: Baseline - week 4
Secondary outcomes:
measure: Abdominal muscle thickness, the thicknesses of the right and left rectus abdominis (RA), obliques externus (OE), obliques internus (OI), and transversus abdominis (TA)
timeFrame: Baseline - week 4
measure: Trunk Control Test (TCT),
timeFrame: Baseline - week 4
measure: Forced expiratory volume in one second (FEV1)
timeFrame: Baseline - week 4
measure: Forced vital capacity (FVC)
timeFrame: Baseline - week 4
measure: FEV1/FVC
timeFrame: Baseline - week 4
measure: Peak expiratory flow rate (PEF)
timeFrame: Baseline - week 4
measure: The flow rate between 25% and 75% of FVC (PEF 25%-75%)
timeFrame: Baseline - week 4
measure: Maximum voluntary ventilation (MVV)
timeFrame: Baseline - week 4
measure: Vital capacity (VC)
timeFrame: Baseline - week 4
measure: Inspiratory capacity (IC)
timeFrame: Baseline - week 4
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
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