By InvitationNot Applicable

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

Turkey (Türkiye)40 participantsStarted 2025-06-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Change in Suprahyoid Muscle Thickness

Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)

Change in Suprahyoid Muscle Cross-Sectional Area

Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)

Change in Suprahyoid Muscle Echogenicity

Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)

Change in Suprahyoid Muscle Stiffness

Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)

Change in Penetration-Aspiration Scale (PAS) Score

Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)

Change in Bolus Residue Scale (BRS) Score

Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)

Change in Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Score

Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)

Trial details

NCT IDNCT07445204

SponsorIstanbul Arel University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More Dysphagia trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Suprahyoid Muscle Thickness

Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)

Change in Suprahyoid Muscle Cross-Sectional Area

Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)

Change in Suprahyoid Muscle Echogenicity

Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)

Change in Suprahyoid Muscle Stiffness

Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)

Change in Penetration-Aspiration Scale (PAS) Score

Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)

Change in Bolus Residue Scale (BRS) Score

Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)

Change in Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Score

Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)