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

October 23, 2023 updated by: Handan Elif Nur BAYRAKTAR, Ankara City Hospital Bilkent

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?"

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
Other: Isometric strengthening exercises
Isometric abdominal strengthening exercises are part of the standard rehabilitation program for individuals with spinal cord injuries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Functional Reach Test (mFRT) (reaching of forward, right, left)
Time Frame: Baseline - week 4
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal muscle thickness, the thicknesses of the right and left rectus abdominis (RA), obliques externus (OE), obliques internus (OI), and transversus abdominis (TA)
Time Frame: Baseline - week 4
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
Trunk Control Test (TCT),
Time Frame: Baseline - week 4
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
Forced expiratory volume in one second (FEV1)
Time Frame: Baseline - week 4
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
Forced vital capacity (FVC)
Time Frame: Baseline - week 4
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
FEV1/FVC
Time Frame: Baseline - week 4
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
Peak expiratory flow rate (PEF)
Time Frame: Baseline - week 4
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
The flow rate between 25% and 75% of FVC (PEF 25%-75%)
Time Frame: Baseline - week 4
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
Maximum voluntary ventilation (MVV)
Time Frame: Baseline - week 4
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
Vital capacity (VC)
Time Frame: Baseline - week 4
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
Inspiratory capacity (IC)
Time Frame: Baseline - week 4
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2022

Primary Completion (Actual)

April 11, 2023

Study Completion (Actual)

April 11, 2023

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraCHBilkent-PMR-DRHENY-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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