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Dysphagia After StrokeNot existNCT06887855

Enhancing Post-Stroke Dysphagia Rehabilitation

A study testing Neuromuscular Electrical Stimulation, Neuromuscular Taping and Swallowing exercise (Expiratory Muscle Strength Training) in people with Dysphagia After Stroke, run by Hamad Medical Corporation at 1 site in Qatar.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Dysphagia After Stroke
What is being tested?
Neuromuscular Electrical Stimulation, Neuromuscular Taping and Swallowing exercise (Expiratory Muscle Strength Training)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteQatar
Study dates
1 Nov 2024to 30 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ibrahim Mohammad Alayaseh, M. Sc. _ SLP contact

+ 974 66888533 ext. 66888533

ialayaseh@hamad.qa

Qatar1 site, 1 recruiting

  • Hamad Medical Corporation

    Doha, Baladiyat ad Dawhah, 3050

    Mohammad Medical Research Center, M. Sc. _ SLP, +974-44392440 ext. /6162/6163/616, research@hamad.qa

    Prem Mohammad Chandra, Ph.D., + 974 55971531, pchandra@hamad.qa

    Recruiting

Other trials in Qatar

About this study

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

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).
Read more

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.
Read the 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.

Being tested
Neuromuscular Electrical Stimulation, Neuromuscular Taping, Swallowing exercise (Expiratory Muscle Strength Training), Swallowing exercise (Chin Tuck Against Resistance)
Keywords
post-stroke, dysphagia, combined rehabilitation, neuromuscular electrical stimulation, kinesiology taping, neuromuscular taping, chin tuck against resistance, expiratory muscle strength training
Medical subject headings
Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular Electrical StimulationProcedure or surgery

    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 TapingProcedure or surgery

    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 or surgery

    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 or surgery

    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).

Study groups in NCT06887855
Study groupRoleWhat they receive
Group AExperimentalParticipants will receive neuromuscular electrical stimulation + swallowing exercises ( chin tuck against resistance + expiratory muscle strength training)
Receives: Procedure: Neuromuscular Electrical Stimulation; Procedure: Swallowing exercise (Expiratory Muscle Strength Training); Procedure: Swallowing exercise (Chin Tuck Against Resistance)
Group BExperimentalParticipants will receive neuromuscular taping + swallowing exercises (chin tuck against resistance + expiratory muscle strength training)
Receives: Procedure: Neuromuscular Taping; Procedure: Swallowing exercise (Expiratory Muscle Strength Training); Procedure: Swallowing exercise (Chin Tuck Against Resistance)
Group CExperimentalParticipants will receive neuromuscular electrical stimulation + neuromuscular taping + swallowing exercises (chin tuck against resistance + expiratory muscle strength training)
Receives: Procedure: Neuromuscular Electrical Stimulation; Procedure: Neuromuscular Taping; Procedure: Swallowing exercise (Expiratory Muscle Strength Training); Procedure: Swallowing exercise (Chin Tuck Against Resistance)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (2)

  1. DYSPHAGIA OUTCOME SEVERITY SCALE (DOSS)

    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.

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

  2. Hyoid bone displacement

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2025
  2. Study start1 Nov 2024
  3. Primary completion30 Aug 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study includes 3 intervention groups.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06887855
Sponsor's protocol ID
MRC-01-23-242
Other IDs
Not exist
Acronym
Not exist
Status last verified
Mar 2025
First submitted
13 Mar 2025
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data sharing requires permission from the Qatar Ministry of Public Health. Any request for data requisition can be made to the Medical Research Center (MRC) at Hamad Medical Corporation Qatar, which will seek legal permission from the Ministry of Public Health before sharing the data.

Publications

  • Xia W, Zheng C, Lei Q, Tang Z, Hua Q, Zhang Y, Zhu S. Treatment of post-stroke dysphagia by vitalstim therapy coupled with conventional swallowing training. J Huazhong Univ Sci Technolog Med Sci. 2011 Feb;31(1):73-76. doi: 10.1007/s11596-011-0153-5. Epub 2011 Feb 19.

    PubMed 21336727

  • Wang Y, Li X, Sun C, Xu R. Effectiveness of kinesiology taping on the functions of upper limbs in patients with stroke: a meta-analysis of randomized trial. Neurol Sci. 2022 Jul;43(7):4145-4156. doi: 10.1007/s10072-022-06010-1. Epub 2022 Mar 26.

    PubMed 35347525

  • Teo, J. T., Chin, Y. L., & Wong, M. L. (2021). Dysphagia management in post-stroke patients: The role of combined interventions. Stroke Research and Treatment, 2021, 4520345. https://doi.org/10.1155/2021/4520345

  • Tarihci Cakmak E, Sen EI, Doruk C, Sen C, Sezikli S, Yaliman A. The Effects of Neuromuscular Electrical Stimulation on Swallowing Functions in Post-stroke Dysphagia: A Randomized Controlled Trial. Dysphagia. 2023 Jun;38(3):874-885. doi: 10.1007/s00455-022-10512-7. Epub 2022 Aug 20.

    PubMed 35986170

  • Tan Z, Wei X, Tan C, Wang H, Tian S. Effect of neuromuscular electrical stimulation combined with swallowing rehabilitation training on the treatment efficacy and life quality of stroke patients with dysphagia. Am J Transl Res. 2022 Feb 15;14(2):1258-1267. eCollection 2022.

    PubMed 35273727

  • Sproson L, Pownall S, Enderby P, Freeman J. Combined electrical stimulation and exercise for swallow rehabilitation post-stroke: a pilot randomized control trial. Int J Lang Commun Disord. 2018 Mar;53(2):405-417. doi: 10.1111/1460-6984.12359. Epub 2017 Dec 30.

    PubMed 29288590

  • Silva APD, Carvalho ARR, Sassi FC, Andrada E Silva MA. The taping method effects on the trapezius muscle in healthy adults. Codas. 2019 Oct 17;31(5):e20180077. doi: 10.1590/2317-1782/20192018077. eCollection 2019. English, Portuguese.

    PubMed 31644716

  • Silbergleit AK, Schultz L, Jacobson BH, Beardsley T, Johnson AF. The Dysphagia handicap index: development and validation. Dysphagia. 2012 Mar;27(1):46-52. doi: 10.1007/s00455-011-9336-2. Epub 2011 Mar 20.

    PubMed 21424584

  • Propp R, Gill PJ, Marcus S, Ren L, Cohen E, Friedman J, Mahant S. Neuromuscular electrical stimulation for children with dysphagia: a systematic review. BMJ Open. 2022 Mar 25;12(3):e055124. doi: 10.1136/bmjopen-2021-055124.

    PubMed 35338059

  • Park JW, Kim Y, Oh JC, Lee HJ. Effortful swallowing training combined with electrical stimulation in post-stroke dysphagia: a randomized controlled study. Dysphagia. 2012 Dec;27(4):521-7. doi: 10.1007/s00455-012-9403-3. Epub 2012 Mar 24.

    PubMed 22447240

  • Park JS, Hwang NK, Kim HH, Lee G, Jung YJ. Effect of neuromuscular electrical stimulation combined with effortful swallowing using electromyographic biofeedback on oropharyngeal swallowing function in stroke patients with dysphagia: A pilot study. Medicine (Baltimore). 2019 Nov;98(44):e17702. doi: 10.1097/MD.0000000000017702.

    PubMed 31689798

  • Meng P, Zhang S, Wang Q, Wang P, Han C, Gao J, Yue S. The effect of surface neuromuscular electrical stimulation on patients with post-stroke dysphagia. J Back Musculoskelet Rehabil. 2018;31(2):363-370. doi: 10.3233/BMR-170788.

    PubMed 29278871

  • Matos KC, de Oliveira VF, de Oliveira PLC, Carvalho FA, de Mesquita MRM, da Silva Queiroz CG, Marques LM, Lima DLN, Carvalho FMM, Braga-Neto P. Combined conventional speech therapy and functional electrical stimulation in acute stroke patients with dyphagia: a randomized controlled trial. BMC Neurol. 2022 Jun 22;22(1):231. doi: 10.1186/s12883-022-02753-8.

    PubMed 35733098

  • Marcus S, Friedman JN, Lacombe-Duncan A, Mahant S. Neuromuscular electrical stimulation for treatment of dysphagia in infants and young children with neurological impairment: a prospective pilot study. BMJ Paediatr Open. 2019 Jan 23;3(1):e000382. doi: 10.1136/bmjpo-2018-000382. eCollection 2019.

    PubMed 30740545

  • Lin CL, Wu WT, Chang KV, Lin HY, Chou LW. Application of Kinesio Taping method for newborn swallowing difficultly: A case report and literature review. Medicine (Baltimore). 2016 Aug;95(31):e4458. doi: 10.1097/MD.0000000000004458.

    PubMed 27495080

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular Electrical Stimulation, Neuromuscular Taping and Swallowing exercise (Expiratory Muscle Strength Training) in people with Dysphagia After Stroke, run by Hamad Medical Corporation at 1 site in Qatar.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ibrahim Mohammad Alayaseh, M. Sc. _ SLP (+ 974 66888533 ext. 66888533, ialayaseh@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06887855, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.

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