Clinical trial NCT06887855: Enhancing Post-Stroke Dysphagia Rehabilitation
Official title: Enhancing Post-Stroke Dysphagia Rehabilitation Via the Synergistic Effects of Neuromuscular Electrical Stimulation, Neuromuscular Taping, and Swallowing Exercises: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia After Stroke
Keywords: post-stroke
dysphagia
combined rehabilitation
neuromuscular electrical stimulation
kinesiology taping
neuromuscular taping
chin tuck against resistance
expiratory muscle strength training
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2025-03-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study includes 3 intervention groups.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate the effects of a combined swallowing intervention (Neuromuscular Electrical Stimulation (NMES) + Neuromuscular Taping (NMT) + swallowing exercises) on swallowing function and quality of life in post-stroke dysphagia patients. The main questions it aims to answer are:

• Does the combination of swallowing exercises, NMES \& NMT have a greater improvement in dysphagia rehabilitation when compared to either NMES or NMT alone? Researchers will compare the effects of intervention between the three groups (NMES and swallowing exercises, NMT and swallowing exercises, and NMES with NMT and swallowing exercises).

Participants will:

* Receive a combined dysphagia rehabilitation comprised of swallowing exercises, Neuromuscular Electrical stimulation, and/or Neuromuscular Taping.
* Visit the clinic once every 5 days a week for 10 therapy sessions.
* Undergo baseline and post-intervention evaluation procedures.

Detailed description: This proposed study will be conducted using a prospective, three-group, randomized controlled trial. The participants for this study will be recruited from the post-acute and rehabilitation units who are diagnosed with post-stroke dysphagia at Hamad Medical Corporation hospitals in the State of Qatar.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 - 75 years old,
* Diagnosed with swallowing disorders between one day and six months post-stroke,
* Able to attend 10 therapy sessions,
* Have never received any swallowing treatment before participating in this study.

Exclusion Criteria:

* Post-stroke patients with severe cognitive impairment,
* Patients who have swallowing disorders due to other etiologies,
* Patients who need traditional swallowing therapy other than Expiratory Muscle Strength Training (EMST) and Chin Tuck Against Resistance (CTAR). - Skin disorders in the submental area and anterior neck,
* Medical conditions that may affect participation,
* A defibrillator and use precision electrical biomedical devices (e.g. pacemaker, etc.).

Primary outcomes:
measure: Penetration-Aspiration Scale (PAS) score
timeFrame: Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.
measure: Dysphagia Handicap Index
timeFrame: Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.
measure: surface Electromyography (sEMG)
timeFrame: Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.
Secondary outcomes:
measure: DYSPHAGIA OUTCOME SEVERITY SCALE (DOSS)
timeFrame: Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.
measure: Hyoid bone displacement
timeFrame: Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
affiliation: Hamad Medical Corporation
name: Ibrahim Mohammad Alayaseh, M.Sc. _ SLP
role: STUDY_CHAIR
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