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Clinical Trial 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?"


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06104982
Study type Interventional
Source Ankara City Hospital Bilkent
Contact
Status Completed
Phase N/A
Start date February 6, 2022
Completion date April 11, 2023

See also
  Status Clinical Trial Phase
Completed NCT01321333 - Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury Phase 1/Phase 2
Not yet recruiting NCT06274021 - Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury Early Phase 1