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

Spinal Cord Injury Thoracic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06104982
• Other study ID #: AnkaraCHBilkent-PMR-DRHENY-01
• Status: Completed
• Phase: N/A
• Start date: February 6, 2022
• Est. completion date: April 11, 2023

Study information

• Verified date: October 2023
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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?"

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 11, 2023
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury Thoracic
• Wounds and Injuries

Intervention

Device:
• 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.

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

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (24)

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McCaughey EJ, Borotkanics RJ, Gollee H, Folz RJ, McLachlan AJ. Abdominal functional electrical stimulation to improve respiratory function after spinal cord injury: a systematic review and meta-analysis. Spinal Cord. 2016 Sep;54(9):628-39. doi: 10.1038/sc.2016.31. Epub 2016 Apr 12. Erratum In: Spinal Cord. 2016 Sep;54(9):754. Spinal Cord. 2017 Aug;55(8):798. — View Citation

McLachlan AJ, McLean AN, Allan DB, Gollee H. Changes in pulmonary function measures following a passive abdominal functional electrical stimulation training program. J Spinal Cord Med. 2013 Mar;36(2):97-103. doi: 10.1179/2045772312Y.0000000031. — View Citation

Paillard T, Noe F, Passelergue P, Dupui P. Electrical stimulation superimposed onto voluntary muscular contraction. Sports Med. 2005;35(11):951-66. doi: 10.2165/00007256-200535110-00003. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline - week 4
Secondary	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.	Baseline - week 4
Secondary	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.	Baseline - week 4
Secondary	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.	Baseline - week 4
Secondary	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.	Baseline - week 4
Secondary	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.	Baseline - week 4
Secondary	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.	Baseline - week 4
Secondary	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%.	Baseline - week 4
Secondary	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.	Baseline - week 4
Secondary	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.	Baseline - week 4
Secondary	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.	Baseline - week 4