Investigation of the Effect of Neuromuscular Electrical Stimulation Techniques on Suprahyoid Musc… (NCT07445204) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Suprahyoid Muscle Thickness
Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
2
Change in Suprahyoid Muscle Cross-Sectional Area
Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
3
Change in Suprahyoid Muscle Echogenicity
Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
4
Change in Suprahyoid Muscle Stiffness
Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
5
Change in Penetration-Aspiration Scale (PAS) Score
Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
6
Change in Bolus Residue Scale (BRS) Score
Timeframe: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2)
7
Change in Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Score