Investigation of the Effect of Neuromuscular Electrical Stimulation Techniques on Suprahyoid Muscles and Swallowing Function in Acute Hemiparetic Stroke Patients

Обзор

This randomized controlled trial aims to investigate the effects of sensory, motor, and modified combined neuromuscular electrical stimulation (NMES) protocols on swallowing function in patients with acute stroke-related dysphagia. The study compares traditional swallowing rehabilitation alone with three NMES-assisted intervention protocols to determine their impact on swallowing safety, efficiency, and rehabilitation outcomes. Ultrasonographic assessment of hyoid-laryngeal motion will be used as the primary instrumental outcome.

Подробное описание

This randomized controlled, double-blind clinical trial aims to investigate the effects of different neuromuscular electrical stimulation (NMES) protocols-sensory, motor, and modified combined-on the swallowing function and suprahyoid muscle morphology in patients with acute hemiparetic stroke. Dysphagia is one of the most common and serious complications following stroke, leading to nutritional deficiencies, aspiration risk, and reduced quality of life. NMES has been increasingly used in dysphagia rehabilitation as a noninvasive technique that facilitates both peripheral muscle activation and central neuroplasticity.

A total of 40 acute hemiparetic stroke patients diagnosed with dysphagia will be recruited from the Acute Stroke Center of Istinye University Liv Hospital and randomly assigned to four groups:

Group 1: Sensory stimulation (submotor level, below contraction threshold) Group 2: Motor stimulation (supramotor level, visible contraction) Group 3: Modified combined stimulation (motor stimulation on the paretic side and sensory stimulation on the contralateral side) Group 4: Control group (conventional swallowing rehabilitation only) All intervention groups will receive NMES in addition to conventional dysphagia therapy for 10 sessions (40 minutes each). NMES parameters will be standardized as follows: channel mode co-contraction, frequency 80 Hz, pulse duration 180 μs, on-time 3 seconds, and off-time 20 seconds. Electrodes will be placed bilaterally, with the upper pair located above the hyoid bone and the lower pair over the thyrohyoid muscle.

The primary outcome measures will include ultrasonographic assessment of the suprahyoid muscles (muscle thickness, cross-sectional area, echo intensity, and shear-wave elasticity) and dynamic analysis of hyoid-laryngeal movement during swallowing of 5 mL boluses with standardized viscosity levels (IDDSI Level 0 and 4). Measurements will be performed using a LOGIQ P8 ultrasound system with B- and M-mode imaging according to Matsuo's hyoid-laryngeal motion index method.

The secondary outcome measures include videofluoroscopic swallowing study (VFSS) parameters such as the Penetration-Aspiration Scale (PAS), Bolus Residue Scale (BRS), and DIGEST scale, as well as clinical assessments like the Functional Oral Intake Scale (FOIS) and a Nurse Evaluation Form assessing perceived functional improvement via a visual analog scale.

Randomization will be computer-generated (randomizer.org), and all outcome assessments will be conducted by blinded evaluators. The intervention will be delivered by an experienced physiotherapist specialized in dysphagia management.

This study aims to provide comparative evidence on how different NMES stimulation types influence swallowing safety, efficiency, and muscle adaptation in acute stroke. By integrating instrumental (ultrasound and VFSS) and clinical outcomes, the findings will help identify the most effective NMES protocol and contribute to the development of individualized, evidence-based rehabilitation approaches for neurogenic dysphagia.

Вмешательства

• Поведенческое Conventional Swallowing Therapy
  Participants receive only conventional swallowing therapy without neuromuscular electrical stimulation (NMES). Conventional swallowing therapy consists of structured swallowing exercises and compensatory strategies administered by a therapist, including effortful swallow, Mendelsohn maneuver, tongue base exercises, and postural adjustments as clinically indicated. Sessions last approximately 30 minutes for a total of 10 sessions.
• Устройство Vitalstim-Sensory NMES
  Participants receive sensory-level neuromuscular electrical stimulation (NMES) applied to the suprahyoid muscles using a therapeutic stimulator. Stimulation is delivered at sensory threshold without visible muscle contraction. Sessions last approximately 30 minutes for a total of 10 sessions. In addition, participants receive conventional swallowing therapy consisting of structured swallowing exercises and compensatory strategies, including effortful swallow, Mendelsohn maneuver, tongue base ex
• Устройство Vitalstim-Motor NMES
  Participants receive motor-level neuromuscular electrical stimulation (NMES) applied to the suprahyoid muscles using a therapeutic stimulator, eliciting visible muscle contraction. Sessions last approximately 30 minutes for a total of 10 sessions. In addition, participants receive conventional swallowing therapy consisting of structured swallowing exercises and compensatory strategies, including effortful swallow, Mendelsohn maneuver, tongue base exercises, and postural adjustments as clinicall
• Устройство Vitalstim-Combine NMES
  Participants receive combined neuromuscular electrical stimulation (NMES) applied to the suprahyoid muscles using a therapeutic stimulator. Motor-level NMES is applied to the hemiparetic side, while sensory-level NMES is applied to the contralateral side within the same session. Sessions last approximately 30 minutes for a total of 10 sessions. In addition, participants receive conventional swallowing therapy consisting of structured swallowing exercises and compensatory strategies, including e

Первичные конечные точки

• Change in Suprahyoid Muscle Thickness [Срок оценки: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)]
• Change in Suprahyoid Muscle Cross-Sectional Area [Срок оценки: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)]
• Change in Suprahyoid Muscle Echogenicity [Срок оценки: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)]
• Change in Suprahyoid Muscle Stiffness [Срок оценки: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)]
• Change in Penetration-Aspiration Scale (PAS) Score [Срок оценки: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)]
• Change in Bolus Residue Scale (BRS) Score [Срок оценки: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)]
• Change in Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Score [Срок оценки: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)]

Вторичные конечные точки (2)

• Changes in Functional Oral Intake Scale (FOIS) [Срок оценки: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)]
• Changes in Nurse Observation Form for Swallowing Function [Срок оценки: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)]

Критерии участия

Критерии включения

• Age ≥ 18 years, Diagnosis of unilateral hemispheric stroke (ischemic or hemorrhagic) within the past month, Modified Rankin Scale score ≤ 2, NIH Stroke Scale (NIHSS) score ≤ 25, Gugging Swallowing Screen (GUSS) score < 20, Ability to maintain upright sitting position during VFSS and therapy sessions, Voluntary participation with signed informed consent

Критерии исключения

• History of secondary stroke, Inability to follow simple verbal commands Unstable medical condition, History of head or neck cancer, neoplastic tissue growth, or epileptic seizures, Presence of musculoskeletal disorders affecting the neck or swallowing muscles, Cognitive impairment indicated by an IQCODE score > 3.4, Any neurological disease other than stroke that may cause swallowing disorders

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• İstinye University Hospital, Acute Stroke Center — Istanbul

Публикации

• Bulow M, Speyer R, Baijens L, Woisard V, Ekberg O. Neuromuscular electrical stimulation (NMES) in stroke patients with oral and pharyngeal dysfunction. Dysphagia. 2008 Sep;23(3):302-9. doi: 10.1007/s00455-007-9145-9. Epub 2008 Apr 25. PMID 18437464
• Doan TN, Ho WC, Wang LH, Chang FC, Tran TTQ, Chou LW. Therapeutic Effect and Optimal Electrode Placement of Transcutaneous Neuromuscular Electrical Stimulation in Patients with Post-Stroke Dysphagia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Life (Basel). 2022 Jun 10;12(6):875. doi: 10.3390/life12060875. PMID 35743906
• Freed ML, Freed L, Chatburn RL, Christian M. Electrical stimulation for swallowing disorders caused by stroke. Respir Care. 2001 May;46(5):466-74. PMID 11309186
• Guillen-Sola A, Messagi Sartor M, Bofill Soler N, Duarte E, Barrera MC, Marco E. Respiratory muscle strength training and neuromuscular electrical stimulation in subacute dysphagic stroke patients: a randomized controlled trial. Clin Rehabil. 2017 Jun;31(6):761-771. doi: 10.1177/0269215516652446. Epub 2016 Jun 7. PMID 27271373
• Howard MM, Block ES, Mishreki D, Kim T, Rosario ER. The Effect of Sensory Level Versus Motor Level Electrical Stimulation of Pharyngeal Muscles in Acute Stroke Patients with Dysphagia: A Randomized Trial. Dysphagia. 2023 Jun;38(3):943-953. doi: 10.1007/s00455-022-10520-7. Epub 2022 Sep 20. PMID 36127447
• Ichikawa Y, Kikutani T, Sumi M, Iwata H, Takahashi N, Tohara T, Ozeki M, Tamura F. Intramuscular condition of swallowing-related muscles using shear-wave elastography: A preliminary study in healthy adults. J Oral Rehabil. 2024 Nov;51(11):2405-2414. doi: 10.1111/joor.13844. Epub 2024 Aug 16. PMID 39152545
• Lim KB, Lee HJ, Lim SS, Choi YI. Neuromuscular electrical and thermal-tactile stimulation for dysphagia caused by stroke: a randomized controlled trial. J Rehabil Med. 2009 Feb;41(3):174-8. doi: 10.2340/16501977-0317. PMID 19229451
• Lim KB, Lee HJ, Yoo J, Kwon YG. Effect of Low-Frequency rTMS and NMES on Subacute Unilateral Hemispheric Stroke With Dysphagia. Ann Rehabil Med. 2014 Oct;38(5):592-602. doi: 10.5535/arm.2014.38.5.592. Epub 2014 Oct 30. PMID 25379488

Идентификаторы

NCT: NCT07445204 · IstanbulArelU-ETK-2025/47

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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