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

Sponsor
Istanbul Arel University
Study ID
NCT07445204
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Conventional Swallowing Therapy — BEHAVIORAL
    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.
  • Vitalstim-Sensory NMES — DEVICE
    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.
  • Vitalstim-Motor NMES — DEVICE
    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.
  • Vitalstim-Combine NMES — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Mar 3, 2026
Start date
Jun 1, 2025
Status verified
Jul 2025
Primary completion
Sep 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sensory NMES Group
    Participants receive sensory-level neuromuscular electrical stimulation (NMES) applied to the suprahyoid muscles using a therapeutic stimulator. The 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, including traditional swallowing exercises and compensatory strategies.
  • Experimental: Motor NMES Group
    Participants receive motor-level neuromuscular electrical stimulation (NMES) applied to the suprahyoid muscles using a therapeutic stimulator. The stimulation is delivered at motor threshold with visible muscle contraction. Sessions last approximately 30 minutes for a total of 10 sessions. In addition, participants receive conventional swallowing therapy, including traditional swallowing exercises and compensatory strategies.
  • Experimental: Combined NMES Group
    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 at motor threshold with visible muscle contraction, while sensory-level NMES is applied simultaneously to the contralateral (non-hemiparetic) side 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, including traditional swallowing exercises and compensatory strategies.
  • Active Comparator: Control Group
    Participants receive conventional swallowing therapy without neuromuscular electrical stimulation (NMES). Conventional therapy includes traditional swallowing exercises and compensatory strategies administered by a therapist, such as effortful swallow, Mendelsohn maneuver, and tongue base exercises. Sessions last approximately 30 minutes for a total of 10 sessions.

Primary Outcome Measure

Change in Suprahyoid Muscle Thickness [ Time Frame: Baseline (Day 0) and End of treatment (after 10 sessions, Week 2) ]

Find similar trials

Nationwide
Stroke trialsNeurology trialsBrain disorders trials

Related Studies