Electromyography-Triggered Electrical Stimulation on Trunk Balance and Muscle Thickness in SCI Patients

NCT06527417 | Completed

• 1 other identifier: AnkaraCHBilkent-PMR-DRHENY-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to investigate the effect of electromyography (EMG) triggered electrical stimulation (ES) applied to multifidus and erector spinae muscles on trunk balance in patients with complete thoracic spinal cord injury (SCI). The fundamental questions that investigators want to answer are as follows:

• \[question 1\]: "Does multifidus and erector spinae EMG ES improve trunk balance in patients with complete SCI?"
• \[question 2\]: "Does multifidus and erector spinae EMG ES improve muscle thickness in patients with complete SCI?"

Conditions

Spinal Cord Injury Thoracic

Keywords

spinal cord injury; trunk balance; electrical stimulation; multifidus; erector spinae

Outcome Measures

Primary Outcomes (2)

• Trunk control test

  The trunk control test is a useful tool in determining the prognosis of independence in activities of daily living and measuring trunk balance in individuals with spinal cord injury. It was applied to all participants before and after treatment. The test consisted of 3 parts; static control, dynamic control and dynamic control with upper extremity activities.

  Baseline- Week 4

• Modified functional reach test

  The modified functional reach test is a reliable tool to assess sitting reaching in individuals with SCI and to provide immediate feedback to study personnel. It was applied to both groups before and after treatment.

  Baseline- Week 4

Secondary Outcomes (1)

• Erector spinae muscle thickness

  Baseline- Week 4

Other Outcomes (1)

• Multifidus muscle thickness

  Baseline- Week 4

Study Arms (2)

electromyography-triggered electrical stimulation

EXPERIMENTAL

EMG ES was applied to the bilateral multifidus and erector spina muscles of the experimental group 3 times a week for 10 minutes in each session for 4 weeks. At the beginning of each session, the participants were instructed to position themselves in a comfortable sitting position. EMG ES was performed using six self-adhesive electrodes (37 × 64 mm) and two Neuro Trac Myo Plus Pro devices.

Device: Neuro Trac Myo Plus Pro

trunk eccentric exercises

ACTIVE COMPARATOR

The control group performed back eccentric exercises for 4 weeks, 3 times a week, 3 times in each session.

Other: Trunk eccentric exercises

Interventions

Neuro Trac Myo Plus Pro DEVICE

Electrical stimulation parameters; stimuli were monophasic, rectangular, stimulus duration 300 µs, frequency 25 Hertz, amplitude was increased up to a maximum of 100 milliampere until contraction was seen.

electromyography-triggered electrical stimulation

Trunk eccentric exercises OTHER

The control group performed back eccentric exercises for 4 weeks, 3 times a week, 3 times in each session

trunk eccentric exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have traumatic SCI and this injury occurred at least 3 months ago,
• be between the ages of 18 and 65,
• have a neurological injury level between thoracic 4 and thoracic 12
• be fully paraplegic according to the American Spinal Cord Injury Association (ASIA) impairment scale
• be able to sit unsupported in a wheelchair

You may not qualify if:

• patients with a diagnosis of heart failure
• malignancy
• intracardiac defibrillators
• epilepsy
• open wounds
• patients using trunk corsets

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (14)

• Bjerkefors A, Carpenter MG, Cresswell AG, Thorstensson A. Trunk muscle activation in a person with clinically complete thoracic spinal cord injury. J Rehabil Med. 2009 Apr;41(5):390-2. doi: 10.2340/16501977-0336.

  PMID: 19363574 BACKGROUND

• Bergmann M, Zahharova A, Reinvee M, Asser T, Gapeyeva H, Vahtrik D. The Effect of Functional Electrical Stimulation and Therapeutic Exercises on Trunk Muscle Tone and Dynamic Sitting Balance in Persons with Chronic Spinal Cord Injury: A Crossover Trial. Medicina (Kaunas). 2019 Sep 21;55(10):619. doi: 10.3390/medicina55100619.

  PMID: 31546613 BACKGROUND

• Gill M, Linde M, Fautsch K, Hale R, Lopez C, Veith D, Calvert J, Beck L, Garlanger K, Edgerton R, Sayenko D, Lavrov I, Thoreson A, Grahn P, Zhao K. Epidural Electrical Stimulation of the Lumbosacral Spinal Cord Improves Trunk Stability During Seated Reaching in Two Humans With Severe Thoracic Spinal Cord Injury. Front Syst Neurosci. 2020 Nov 19;14:79. doi: 10.3389/fnsys.2020.569337. eCollection 2020.

  PMID: 33328910 BACKGROUND

• Shima D, Nishimura Y, Hashizaki T, Minoshima Y, Yoshikawa T, Umemoto Y, Kinoshita T, Kouda K, Tajima F, Kamijo YI. Surface electromyographic activity of the erector spinae and multifidus during arm- and leg-ergometer exercises in young healthy men. Front Physiol. 2022 Nov 25;13:974632. doi: 10.3389/fphys.2022.974632. eCollection 2022.

  PMID: 36505070 BACKGROUND

• Wilson RD, Page SJ, Delahanty M, Knutson JS, Gunzler DD, Sheffler LR, Chae J. Upper-Limb Recovery After Stroke: A Randomized Controlled Trial Comparing EMG-Triggered, Cyclic, and Sensory Electrical Stimulation. Neurorehabil Neural Repair. 2016 Nov;30(10):978-987. doi: 10.1177/1545968316650278. Epub 2016 May 24.

  PMID: 27225977 BACKGROUND

• Triolo RJ, Bailey SN, Foglyano KM, Kobetic R, Lombardo LM, Miller ME, Pinault G. Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up. Arch Phys Med Rehabil. 2018 Feb;99(2):289-298. doi: 10.1016/j.apmr.2017.08.470. Epub 2017 Sep 9.

  PMID: 28899825 BACKGROUND

• Qiu S, Draghici AE, Picard G, Taylor JA. Muscle Fatigue in Response to Electrical Stimulation Pattern and Frequency in Spinal Cord Injury. PM R. 2020 Jul;12(7):699-705. doi: 10.1002/pmrj.12282. Epub 2019 Dec 12.

  PMID: 31702873 BACKGROUND

• Tharu NS, Alam M, Ling YT, Wong AY, Zheng YP. Combined Transcutaneous Electrical Spinal Cord Stimulation and Task-Specific Rehabilitation Improves Trunk and Sitting Functions in People with Chronic Tetraplegia. Biomedicines. 2022 Dec 23;11(1):34. doi: 10.3390/biomedicines11010034.

  PMID: 36672542 BACKGROUND

• Lee HS, Akimoto T, Kim AR. Effects of trunk extensor eccentric exercise on lipid profile and glycaemic response. BMJ Open Sport Exerc Med. 2020 Oct 28;6(1):e000861. doi: 10.1136/bmjsem-2020-000861. eCollection 2020.

  PMID: 33178444 BACKGROUND

• Quinzanos-Fresnedo J, Fratini-Escobar PC, Almaguer-Benavides KM, Aguirre-Guemez AV, Barrera-Ortiz A, Perez-Zavala R, Villa-Romero AR. Prognostic validity of a clinical trunk control test for independence and walking in individuals with spinal cord injury. J Spinal Cord Med. 2020 May;43(3):331-338. doi: 10.1080/10790268.2018.1518124. Epub 2018 Sep 12.

  PMID: 30207875 BACKGROUND

• 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.

  PMID: 34418026 BACKGROUND

• Masaki M, Aoyama T, Murakami T, Yanase K, Ji X, Tateuchi H, Ichihashi N. Association of low back pain with muscle stiffness and muscle mass of the lumbar back muscles, and sagittal spinal alignment in young and middle-aged medical workers. Clin Biomech (Bristol). 2017 Nov;49:128-133. doi: 10.1016/j.clinbiomech.2017.09.008. Epub 2017 Sep 14.

  PMID: 28934633 BACKGROUND

• Masaki M, Ikezoe T, Fukumoto Y, Minami S, Tsukagoshi R, Sakuma K, Ibuki S, Yamada Y, Kimura M, Ichihashi N. Association of sagittal spinal alignment with thickness and echo intensity of lumbar back muscles in middle-aged and elderly women. Arch Gerontol Geriatr. 2015 Sep-Oct;61(2):197-201. doi: 10.1016/j.archger.2015.05.010. Epub 2015 May 28.

  PMID: 26058723 BACKGROUND

• Bayraktar HEN, Yalcin E, Sipal MS, Akyuz M, Akinci MG, U Delialioglu S. The effect of electromyography triggered electrical stimulation to abdominal muscles on sitting balance, respiratory functions, and abdominal muscle thickness in complete spinal cord injury: a randomized controlled trial. Int J Rehabil Res. 2024 Jun 1;47(2):87-96. doi: 10.1097/MRR.0000000000000620. Epub 2024 Mar 19.

  PMID: 38501227 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: In this randomized controlled and prospective study, investigators included 15 participants with complete thoracic spinal cord injury. Investigators divided the participants into two groups, where one group received the electromyography-triggered electrical stimulation applied to the erector spinae and multifidus muscles, and the control group received trunk eccentric exercises only, applied three times a week for four weeks.

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: August 18, 2023
• Primary Completion: February 18, 2024
• Study Completion: July 25, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)