Enhancing Post-Stroke Dysphagia Rehabilitation

NCT06887855 | Recruiting DMC

• 2 other identifiers: MRC-01-23-242Not exist
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Penetration-Aspiration Scale (PAS) score

  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)

  Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.

• Dysphagia Handicap Index

  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.

  Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.

• surface Electromyography (sEMG)

  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.

  Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.

Secondary Outcomes (2)

• 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.

• Hyoid bone displacement

  Pre-intervention: "Baseline" or "Day 1". Post-intervention: immediately after the intervention, up to 15 days of start the intervention.

Study Arms (3)

Group A

EXPERIMENTAL

Participants will receive neuromuscular electrical stimulation + swallowing exercises ( chin tuck against resistance + expiratory muscle strength training)

Procedure: Neuromuscular Electrical Stimulation; Procedure: Swallowing exercise (Expiratory Muscle Strength Training); Procedure: Swallowing exercise (Chin Tuck Against Resistance)

Group B

EXPERIMENTAL

Participants will receive neuromuscular taping + swallowing exercises (chin tuck against resistance + expiratory muscle strength training)

Procedure: Neuromuscular Taping; Procedure: Swallowing exercise (Expiratory Muscle Strength Training); Procedure: Swallowing exercise (Chin Tuck Against Resistance)

Group C

EXPERIMENTAL

Participants will receive neuromuscular electrical stimulation + neuromuscular taping + swallowing exercises (chin tuck against resistance + expiratory muscle strength training)

Procedure: Neuromuscular Electrical Stimulation; Procedure: Neuromuscular Taping; Procedure: Swallowing exercise (Expiratory Muscle Strength Training); Procedure: Swallowing exercise (Chin Tuck Against Resistance)

Interventions

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).

Group A; Group C

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.

Group B; Group C

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.

Group A; Group B; Group C

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).

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Male/female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation

Doha, Baladīyat ad Dawḩah, 3050, Qatar

RECRUITING

Related Publications (27)

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  BACKGROUND

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  BACKGROUND

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MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Ibrahim Mohammad Alayaseh, M.Sc. _ SLP

  Hamad Medical Corporation

  STUDY CHAIR

Central Study Contacts

Ibrahim Mohammad Alayaseh, M. Sc. _ SLP

CONTACT

+ 974 66888533; ialayaseh@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The outcomes assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Speech-Language Pathology Supervisor

Model Details: The study includes 3 intervention groups.

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start: November 1, 2024
• Primary Completion: August 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)