Spinal Cord Injury ThoracicNCT06104982

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

A study testing NeuroTrac MyoPlus Pro single-channel electromyography biofeedback electrotherapy devices and Isometric strengthening exercises in people with Spinal Cord Injury Thoracic, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Spinal Cord Injury Thoracic
What is being tested?: NeuroTrac MyoPlus Pro single-channel electromyography biofeedback electrotherapy devices and Isometric strengthening exercises
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 6 Feb 2022to 11 Apr 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

malignancy,
epilepsy, heart failure,
intracardiac defibrillator (ICD)
an open wound in the application area

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ankara City Hospital
Ankara

Other trials in Turkey (Türkiye)

About this study

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?"

Read the 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.

Conditions: Spinal Cord Injury Thoracic
Being tested: NeuroTrac MyoPlus Pro single-channel electromyography biofeedback electrotherapy devices, Isometric strengthening exercises
Keywords: spinal cord injury, abdominal muscle, electrical stimulation, sitting balance
Medical subject headings: Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NeuroTrac MyoPlus Pro single-channel electromyography biofeedback electrotherapy devicesDevice
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 strengthening exercisesOther
Isometric abdominal strengthening exercises are part of the standard rehabilitation program for individuals with spinal cord injuries.

Study groups in NCT06104982
Study group	Role	What they receive
SiFES group	Experimental	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. Receives: Device: NeuroTrac MyoPlus Pro single-channel electromyography biofeedback electrotherapy devices
Control group (TE group)	Active comparator	The investigators administered isometric strengthening to the TE groups, three days a week, with three sets per session, a period of four weeks. Receives: Other: Isometric strengthening exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline - week 4

Secondary outcomes (10)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline - week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Feb 202211 Apr 2023

First posted27 Oct 2023
Study start6 Feb 2022
Primary completion11 Apr 2023
Study completion11 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Spinal Cord Injury ThoracicStudies of the same condition, open and under way.
More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06104982
Sponsor's protocol ID: AnkaraCHBilkent-PMR-DRHENY-01
Status last verified: Oct 2023
First submitted: 17 Oct 2023
Last updated: 27 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Arsh A, Darain H, Rahman MU, Ullah I, Shakil-Ur-Rehman S. Reliability of modified functional reach test in the assessment of balance function in people with spinal cord injury: A systematic review. J Pak Med Assoc. 2021 Aug;71(8):2040-2044. doi: 10.47391/JPMA.1276.
PubMed 34418026
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.
PubMed 27067658
Hascakova-Bartova R, Dinant JF, Parent A, Ventura M. Neuromuscular electrical stimulation of completely paralyzed abdominal muscles in spinal cord-injured patients: a pilot study. Spinal Cord. 2008 Jun;46(6):445-50. doi: 10.1038/sj.sc.3102166. Epub 2008 Jan 29.
PubMed 18227852
Gater DR Jr, Dolbow D, Tsui B, Gorgey AS. Functional electrical stimulation therapies after spinal cord injury. NeuroRehabilitation. 2011;28(3):231-48. doi: 10.3233/NRE-2011-0652. No abstract available.
PubMed 21558629
Cheng PT, Chen CL, Wang CM, Chung CY. Effect of neuromuscular electrical stimulation on cough capacity and pulmonary function in patients with acute cervical cord injury. J Rehabil Med. 2006 Jan;38(1):32-6. doi: 10.1080/16501970510043387.
PubMed 16548084
McBain RA, Boswell-Ruys CL, Lee BB, Gandevia SC, Butler JE. Abdominal muscle training can enhance cough after spinal cord injury. Neurorehabil Neural Repair. 2013 Nov-Dec;27(9):834-43. doi: 10.1177/1545968313496324. Epub 2013 Jul 24.
PubMed 23884017
Bersch I, Friden J. Role of Functional Electrical Stimulation in Tetraplegia Hand Surgery. Arch Phys Med Rehabil. 2016 Jun;97(6 Suppl):S154-9. doi: 10.1016/j.apmr.2016.01.035.
PubMed 27233590
Chandrasekaran S, Davis J, Bersch I, Goldberg G, Gorgey AS. Electrical stimulation and denervated muscles after spinal cord injury. Neural Regen Res. 2020 Aug;15(8):1397-1407. doi: 10.4103/1673-5374.274326.
PubMed 31997798
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.
PubMed 16271009
Amerijckx C, Goossens N, Pijnenburg M, Musarra F, van Leeuwen DM, Schmitz M, Janssens L. Influence of phase of respiratory cycle on ultrasound imaging of deep abdominal muscle thickness. Musculoskelet Sci Pract. 2020 Apr;46:102105. doi: 10.1016/j.msksp.2019.102105. Epub 2019 Dec 27.
PubMed 32217268
Tahan N, Khademi-Kalantari K, Mohseni-Bandpei MA, Mikaili S, Baghban AA, Jaberzadeh S. Measurement of superficial and deep abdominal muscle thickness: an ultrasonography study. J Physiol Anthropol. 2016 Aug 23;35(1):17. doi: 10.1186/s40101-016-0106-6.
PubMed 27553830
Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
PubMed 31613151
Lynch SM, Leahy P, Barker SP. Reliability of measurements obtained with a modified functional reach test in subjects with spinal cord injury. Phys Ther. 1998 Feb;78(2):128-33. doi: 10.1093/ptj/78.2.128.
PubMed 9474105
Quinzanos J, Villa AR, Flores AA, Perez R. Proposal and validation of a clinical trunk control test in individuals with spinal cord injury. Spinal Cord. 2014 Jun;52(6):449-54. doi: 10.1038/sc.2014.34. Epub 2014 Apr 8.
PubMed 24710149
Baek SO, Cho HK, Kim SY, Jones R, Cho YW, Ahn SH. Changes in deep lumbar stabilizing muscle thickness by transcutaneous neuromuscular electrical stimulation in patients with low back pain. J Back Musculoskelet Rehabil. 2017;30(1):121-127. doi: 10.3233/BMR-160723.
PubMed 27341642

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Spinal Cord Injury Thoracic trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Superimposed Electrical Stimulation on Sitting Balance, Respiratory Functions, and Abdominal Muscle Thickness in Complete Spinal Cord Injury
ClinicalTrials.gov ID: NCT06104982
Acronym / sponsor ID: AnkaraCHBilkent-PMR-DRHENY-01
Conditions: Spinal Cord Injury Thoracic
Keywords: spinal cord injury, abdominal muscle, electrical stimulation, sitting balance
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Ankara City Hospital BilkentUniversity, hospital or other
Study start: 6 Feb 2022 (actual)
Primary completion: 11 Apr 2023 (actual)
Study completion: 11 Apr 2023 (actual)
First posted: 27 Oct 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
SiFES group	Experimental	Device: NeuroTrac MyoPlus Pro single-channel electromyography biofeedback electrotherapy devicesThe 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.
Control group (TE group)	Active comparator	Other: Isometric strengthening exercisesThe investigators administered isometric strengthening to the TE groups, three days a week, with three sets per session, a period of four weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

malignancy,
epilepsy, heart failure,
intracardiac defibrillator (ICD)
an open wound in the application area

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NeuroTrac MyoPlus Pro single-channel electromyography biofeedback electrotherapy devicesNeuromuscular 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.	Device	SiFES group
Isometric strengthening exercisesIsometric abdominal strengthening exercises are part of the standard rehabilitation program for individuals with spinal cord injuries.	Other	Control group (TE group)

Primary outcome

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.

10 secondary outcomes

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
Trunk Control Test (TCT),
Time frame: Baseline - week 4
Forced expiratory volume in one second (FEV1)
Time frame: Baseline - week 4
Forced vital capacity (FVC)
Time frame: Baseline - week 4
FEV1/FVC
Time frame: Baseline - week 4
Peak expiratory flow rate (PEF)
Time frame: Baseline - week 4
The flow rate between 25% and 75% of FVC (PEF 25%-75%)
Time frame: Baseline - week 4
Maximum voluntary ventilation (MVV)
Time frame: Baseline - week 4
Vital capacity (VC)
Time frame: Baseline - week 4
Inspiratory capacity (IC)
Time frame: Baseline - week 4

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
Background: PubMed 34418026Arsh A, Darain H, Rahman MU, Ullah I, Shakil-Ur-Rehman S. Reliability of modified functional reach test in the assessment of balance function in people with spinal cord injury: A systematic review. J Pak Med Assoc. 2021 Aug;71(8):2040-2044. doi: 10.47391/JPMA.1276.
Background: PubMed 27067658McCaughey 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.
Background: PubMed 18227852Hascakova-Bartova R, Dinant JF, Parent A, Ventura M. Neuromuscular electrical stimulation of completely paralyzed abdominal muscles in spinal cord-injured patients: a pilot study. Spinal Cord. 2008 Jun;46(6):445-50. doi: 10.1038/sj.sc.3102166. Epub 2008 Jan 29.
Background: PubMed 21558629Gater DR Jr, Dolbow D, Tsui B, Gorgey AS. Functional electrical stimulation therapies after spinal cord injury. NeuroRehabilitation. 2011;28(3):231-48. doi: 10.3233/NRE-2011-0652. No abstract available.
Background: PubMed 16548084Cheng PT, Chen CL, Wang CM, Chung CY. Effect of neuromuscular electrical stimulation on cough capacity and pulmonary function in patients with acute cervical cord injury. J Rehabil Med. 2006 Jan;38(1):32-6. doi: 10.1080/16501970510043387.
Background: PubMed 23884017McBain RA, Boswell-Ruys CL, Lee BB, Gandevia SC, Butler JE. Abdominal muscle training can enhance cough after spinal cord injury. Neurorehabil Neural Repair. 2013 Nov-Dec;27(9):834-43. doi: 10.1177/1545968313496324. Epub 2013 Jul 24.
Background: PubMed 27233590Bersch I, Friden J. Role of Functional Electrical Stimulation in Tetraplegia Hand Surgery. Arch Phys Med Rehabil. 2016 Jun;97(6 Suppl):S154-9. doi: 10.1016/j.apmr.2016.01.035.
Background: PubMed 31997798Chandrasekaran S, Davis J, Bersch I, Goldberg G, Gorgey AS. Electrical stimulation and denervated muscles after spinal cord injury. Neural Regen Res. 2020 Aug;15(8):1397-1407. doi: 10.4103/1673-5374.274326.
Background: PubMed 16271009Paillard 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.
Background: PubMed 32217268Amerijckx C, Goossens N, Pijnenburg M, Musarra F, van Leeuwen DM, Schmitz M, Janssens L. Influence of phase of respiratory cycle on ultrasound imaging of deep abdominal muscle thickness. Musculoskelet Sci Pract. 2020 Apr;46:102105. doi: 10.1016/j.msksp.2019.102105. Epub 2019 Dec 27.
Background: PubMed 27553830Tahan N, Khademi-Kalantari K, Mohseni-Bandpei MA, Mikaili S, Baghban AA, Jaberzadeh S. Measurement of superficial and deep abdominal muscle thickness: an ultrasonography study. J Physiol Anthropol. 2016 Aug 23;35(1):17. doi: 10.1186/s40101-016-0106-6.
Background: PubMed 31613151Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Functional Reach Test (mFRT) (reaching of forward, right, left) (time frame: Baseline - week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06104982, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.