Enhancing Post-Stroke Dysphagia Rehabilitation

Not Applicable

Recruiting

• Conditions: Dysphagia After Stroke

• Registration Number: NCT06887855
• Lead Sponsor: Hamad Medical Corporation

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.

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-15
• Last Update Submitted: 2025-03-15
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-08-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Penetration-Aspiration Scale (PAS) score	Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.	It is an 8-point ordinal scale, with 1 representing the least and 8 representing the highest or most severe score. PAS scores are multidimensional, i.e., include several observations within each score: (1) depth of airway invasion (material above, contacting, or below the level of vocal folds; (2) whether or not there is material remaining after the swallow (ejected, not ejected); and (3) the patient's response to material present in the airway (effort to clear the material)
Dysphagia Handicap Index	Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.	Dysphagia Handicap Index is comprised of a 25-item self-administered questionnaire. It is an instrument for measuring the handicapping impact of swallowing disorder on the physical, functional, and emotional facets of individuals' lives.; Respondents replied never, sometimes, or always to each statement and rated their self-perceived dysphagia severity on a 7-point equal-appearing interval scale. 1 indicates normal swallowing and 7 indicates server swallowing problem.
surface Electromyography (sEMG)	Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.	Surface EMG biofeedback is typically implemented by placing surface electrodes over a patient's under-chin area or submental muscles to observe the changes in muscle actions during swallowing. The recorded signals are processed and converted into a visual demonstration or auditory prompt. The participants' swallowing muscles (suprahyoid) performance will be measured using the maximum work parameter to compare each participant's performance per- and post- intervention.

Secondary Outcome Measures

Name	Time	Method
DYSPHAGIA OUTCOME SEVERITY SCALE (DOSS)	Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.	DOSS is a simple, easy-to-use, 7-point scale developed to systematically rate the functional severity of dysphagia based on objective assessment and make recommendations for diet level, independence level, and type of nutrition.
Hyoid bone displacement	Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.	The physiology of swallowing involves many biomechanical processes, such as displacement of the hyoid bone, which is an important part of protecting the airway and the opening of the upper esophageal sphincter. The displacement of the hyoid bone will be measured based on the videofluoroscopic swallow study.

Trial Locations

Locations (1)

Hamad Medical Corporation; 🇶🇦 Doha, Qatar