Investigation of the Effect of Neuromuscular Electrical Stimulation Techniques on Suprahyoid Muscles and Swallowing Function in Acute Hemiparetic Stroke Patients
NCT07445204 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-03-03
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.
Conditions
Interventions
- BEHAVIORAL
-
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.
- DEVICE
-
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 exercises, and postural adjustments as clinically indicated.
- DEVICE
-
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 clinically indicated.
- DEVICE
-
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 effortful swallow, Mendelsohn maneuver, tongue base exercises, and postural adjustments as clinically indicated.
Sponsors & Collaborators
-
Istinye University
collaborator OTHER -
Hacettepe University
collaborator OTHER -
Istanbul Arel University
lead OTHER
Principal Investigators
-
Rabia KUM GÜLER, PhD(c), PT · Istanbul Arel U
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-01
- Primary Completion
- 2026-09-30
- Completion
- 2026-12-30
Countries
- Turkey (Türkiye)
Study Locations
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