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?"
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
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.
Isometric abdominal strengthening exercises are part of the standard rehabilitation program for individuals with spinal cord injuries.
Ankara City Hospital
Ankara, Turkey (Türkiye)
Modified Functional Reach Test (mFRT) (reaching of forward, right, left)
The mFRT, which is a validated and reliable tool for measuring sitting balance in patients with SCI was used in this study. Before the investigators conducted the test, the participant was positioned in an upright sitting posture in a wheelchair. The investigators took measurements in three directions: forward reach (using the dominant extremity), right reach, and left reach, both before and after the treatment, for both groups. During the modified functional reach test, the participants reached out as far as possible in the forward, right, and left directions. The investigators repeated the test three times, and there was a 5-minute interval between each repetition. The investigators recorded the best measurement out of the three trials in centimeters.
Time frame: Baseline - week 4
Abdominal muscle thickness, the thicknesses of the right and left rectus abdominis (RA), obliques externus (OE), obliques internus (OI), and transversus abdominis (TA)
The investigators conducted muscle thickness measurements using an 8-12 megahertz (MHz) linear probe on a real-time B mode USG device (GE LOGIQ 7, General Electric Co., Wisconsin, USA). The investigators took measurements at the end of expiration while the patient was lying on their back, with their body exposed and a pillow placed under their head. The investigators applied gel between the probe and the skin to ensure proper contact and accurate measurements. To measure the RA thickness, two centimeters lateral to the umbilicus were marked on both the right and left sides. To measure the thicknesses of the OE, OI, and TA muscles, the lowest point of the 11th rib and the midpoint of the iliac crest were marked on both the right and left sides at the level of the anterior axillary line. The investigators took three measurements from these marked points both before and after the treatment, and recorded the average of these measurements in centimeters.
Time frame: Baseline - week 4
Trunk Control Test (TCT),
The TCT is a test with proven validity and reliability, used to measure trunk balance in patients with SCI. The investigators conducted TCT both before and after the treatment in both groups. The TCT comprises two parts: static and dynamic balance assessments, which involve reaching for variable targets and assuming required positions. The investigators evaluated participants using a scoring system ranging from 0 to 24, both before and after the treatment. The score reflects their performance in maintaining trunk balance, with higher scores indicating better trunk control.
Time frame: Baseline - week 4
Forced expiratory volume in one second (FEV1)
The PFT is a laboratory method used for diagnosing and monitoring lung diseases, and objectively evaluating lung functions. In the current study, the investigators measured the PFT by the same person before and after treatment in both groups, using a simple spirometer device (COSMED, Pony FX) at the Ankara City Hospital Physical Therapy Hospital Cardiopulmonary Rehabilitation Unit. The investigators conducted the PFT three times for each participant and recorded the best spirogram image. From these spirometry results, the investigators recorded the FEV1.
Time frame: Baseline - week 4
Forced vital capacity (FVC)
The PFT is a laboratory method used for diagnosing and monitoring lung diseases, and objectively evaluating lung functions. In the current study, the investigators measured the PFT by the same person before and after treatment in both groups, using a simple spirometer device (COSMED, Pony FX) at the Ankara City Hospital Physical Therapy Hospital Cardiopulmonary Rehabilitation Unit. The investigators conducted the PFT three times for each participant and recorded the best spirogram image. From these spirometry results, the investigators recorded the FVC.
Time frame: Baseline - week 4
FEV1/FVC
The PFT is a laboratory method used for diagnosing and monitoring lung diseases, and objectively evaluating lung functions. In the current study, the investigators measured the PFT by the same person before and after treatment in both groups, using a simple spirometer device (COSMED, Pony FX) at the Ankara City Hospital Physical Therapy Hospital Cardiopulmonary Rehabilitation Unit. The investigators conducted the PFT three times for each participant and recorded the best spirogram image. From these spirometry results, the investigators recorded the FEV1/FVC.
Time frame: Baseline - week 4
Peak expiratory flow rate (PEF)
The PFT is a laboratory method used for diagnosing and monitoring lung diseases, and objectively evaluating lung functions. In the current study, the investigators measured the PFT by the same person before and after treatment in both groups, using a simple spirometer device (COSMED, Pony FX) at the Ankara City Hospital Physical Therapy Hospital Cardiopulmonary Rehabilitation Unit. The investigators conducted the PFT three times for each participant and recorded the best spirogram image. From these spirometry results, the investigators recorded the PEF.
Time frame: Baseline - week 4
The flow rate between 25% and 75% of FVC (PEF 25%-75%)
The PFT is a laboratory method used for diagnosing and monitoring lung diseases, and objectively evaluating lung functions. In the current study, the investigators measured the PFT by the same person before and after treatment in both groups, using a simple spirometer device (COSMED, Pony FX) at the Ankara City Hospital Physical Therapy Hospital Cardiopulmonary Rehabilitation Unit. The investigators conducted the PFT three times for each participant and recorded the best spirogram image. From these spirometry results, the investigators recorded the PEF 25%-75%.
Time frame: Baseline - week 4
Maximum voluntary ventilation (MVV)
The PFT is a laboratory method used for diagnosing and monitoring lung diseases, and objectively evaluating lung functions. In the current study, the investigators measured the PFT by the same person before and after treatment in both groups, using a simple spirometer device (COSMED, Pony FX) at the Ankara City Hospital Physical Therapy Hospital Cardiopulmonary Rehabilitation Unit. The investigators conducted the PFT three times for each participant and recorded the best spirogram image. From these spirometry results, the investigators recorded the MVV.
Time frame: Baseline - week 4
Vital capacity (VC)
The PFT is a laboratory method used for diagnosing and monitoring lung diseases, and objectively evaluating lung functions. In the current study, the investigators measured the PFT by the same person before and after treatment in both groups, using a simple spirometer device (COSMED, Pony FX) at the Ankara City Hospital Physical Therapy Hospital Cardiopulmonary Rehabilitation Unit. The investigators conducted the PFT three times for each participant and recorded the best spirogram image. From these spirometry results, the investigators recorded the VC.
Time frame: Baseline - week 4
Inspiratory capacity (IC)
The PFT is a laboratory method used for diagnosing and monitoring lung diseases, and objectively evaluating lung functions. In the current study, the investigators measured the PFT by the same person before and after treatment in both groups, using a simple spirometer device (COSMED, Pony FX) at the Ankara City Hospital Physical Therapy Hospital Cardiopulmonary Rehabilitation Unit. The investigators conducted the PFT three times for each participant and recorded the best spirogram image. From these spirometry results, the investigators recorded the IC.
Time frame: Baseline - week 4
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