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

Overview

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.

Interventions

• Procedure Neuromuscular Electrical Stimulation
  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
• Procedure Neuromuscular Taping
  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 swal
• Procedure Swallowing exercise (Expiratory Muscle Strength Training)
  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.
• Procedure Swallowing exercise (Chin Tuck Against Resistance)
  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 outcome measures

• 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.]
• 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.]
• 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.]

Secondary outcome measures (2)

• 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.]
• 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.]

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.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Qatar · 1 center

• Hamad Medical Corporation — Doha

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 21424584

Identifiers

NCT: NCT06887855 · MRC-01-23-242 · Not exist

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗