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NCT Number: NCT06887855

Enhancing Post-Stroke Dysphagia Rehabilitation

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Neuromuscular Electrical Stimulation

Procedure

NMES is a modality for stimulating muscles through electrical pulses, is used widely in the rehabilitation of stroke patients with pharyngeal dysphagia. It reinforces the strength of the muscles for swallowing and smooths the swallowing reflex through sensory stimulation. Clinically, NMES is applied to depolarize nerve fibers at the point of engagement, involving muscle contraction (Park et al. 2019). NMES includes the placement of electrical stimuli to the skin around the face and neck through surface electrodes. Stimulation intensity can be diverse depending on the treatment objectives. Low-intensity (sensory) NMES lets patients feel the tingling sensation on the skin, whereas high-intensity (motor) NMES can stimulate muscle contractions (Cheng et al. 2022).

Neuromuscular Taping

Procedure

NMT is similar to kinesiology taping but specifically focuses on neuromuscular re-education and it is a commonly used therapy approach for various neuromuscular problems. The neuromuscular tape can be easily applied to skeletal muscles to induce or inhibit muscle activity and to support the stabilization of structures such as joints and ligaments. The elasticity and adhesion properties of NMT can be used to restrain the anterior-upward movement of the hyolaryngeal complex during spontaneous swallowing. This effect increases the load on the suprahyoid muscles and consequently, the patient spends more effort to overcome this movement while swallowing. Resistance exercises provided with NMT activate the suprahyoid muscle and contractions for the muscles of the tongue.

Swallowing exercise (Expiratory Muscle Strength Training)

Procedure

IN EMST the patients blow into a one-way spring-loaded apparatus calibrated to a percentage of maximum expiratory pressure until the valve opens with adequate effort. Four to eight weeks of EMST exercises increased the maximum expiratory pressure (MEP), maximum hyoid displacement, suprahyoid muscle action, and swallowing safety in patients with amyotrophic lateral sclerosis, stroke, and neck cancer.

Swallowing exercise (Chin Tuck Against Resistance)

Procedure

CTAR exercise is performed by an inflatable 12 cm rubber ball. The patients are directed to sit upright on a chair and hold the rubber ball between the base of the chin and the manubrium sterna. This exercise is composed of isometric and isotonic movements. The isometric movement will be performed for 10 seconds, whereas the isokinetic movement will be successively repeated 10 times to strengthen the suprahyoid and infrahyoid muscles (Kagaya & Inamoto, 2022).

Primary outcomes

  1. Penetration-Aspiration Scale (PAS) score

    Time frame: 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)

  2. Dysphagia Handicap Index

    Time frame: 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.

  3. surface Electromyography (sEMG)

    Time frame: 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 outcomes

  1. DYSPHAGIA OUTCOME SEVERITY SCALE (DOSS)

    Time frame: 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.

  2. Hyoid bone displacement

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ibrahim Mohammad Alayaseh, M. Sc. _ SLP

CONTACT

[email protected]

+ 974 66888533 ext. 66888533

Sponsors and collaborators

Lead sponsor

Hamad Medical Corporation

Industry

Registry information

Official study title

Enhancing Post-Stroke Dysphagia Rehabilitation Via the Synergistic Effects of Neuromuscular Electrical Stimulation, Neuromuscular Taping, and Swallowing Exercises: a Randomized Controlled Trial

Acronym: Not exist

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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