Clinical trial NCT06321406: Effect of Superficial Neuromuscular Stimulation in Post-stroke Dysphagic Patients.
Official title: Effect of Superficial Neuromuscular Stimulation on Ultrasonographic Findings of Oropharyngeal Swallowing in Post-stroke Dysphagic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Stroke
Keywords: dysphagia
post-stroke dysphagia
rehabilitation
ultrasonography
Lead sponsor: Kayseri City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-20
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Swallowing disorder in stroke patients is a significant cause of morbidity and mortality as it can cause aspiration pneumonia. Electrical stimulation has proven to be effective in post-stroke dysphagic patients.10 patients who have symptoms of post-stroke dysphagia, meet the inclusion criteria and volunteer to participate will be included in the study. Included patients will be randomized into 2 groups. The exercise program will be applied to both groups as a home program for 4 weeks.

Detailed description: A randomized, prospective, controlled study will include 10 patients with post-stroke dysphagia. Groups will be randomized into 2 groups.

1. st group; One electrode will be connected to the suprahyoid region and the other electrode will be connected between the thyroid and hyoid cartilages. Superficial neuromuscular stimulation will be applied by the physiotherapist at 80 Hz, 0-25 µA (microampere) current range for 20 minutes, for 5 days for the patient, for a total of 4 weeks. At the same time, each patient will be taught the exercises included in traditional swallowing treatment and will be advised to practice them for 30 minutes every day.
2. nd group; Exercises such as progressively resistant oral-facial, lingual, laryngeal exercises, tongue strengthening exercises, effortful swallowing maneuver, thermal/tactile stimulation to oropharyngeal muscles, Masako maneuver, Mendelson maneuver, Shaker maneuver, which are included in traditional swallowing treatment, will be taught and practiced for 30 minutes will be recommended for one month.

Patients' dysphagia scales, quality of life survey and ultrasonography measurements will be performed before and after treatment.

Tests to be applied

* Functional Oral Intake Scale (FOAS)
* Swallowing Function Screening Test (EAT-10)
* GUSS (Gagging Swallowing Screening Test)
* Modified Mann Swallowing Ability Assessment Test (MMASA)
* SWAL-QOL (The impact of swallowing disorders on quality of life questionnaire),
* Measurements made by ultrasonography (measurement of tongue thickness, measurement of hyoid-larynx distance and measurements of other anatomical structures)

Clinic Responsible for Research: Physical Therapy and Rehabilitation Clinic of Kayseri City Hospital

Eligibility criteria: Inclusion Criteria:

* Male and female patients over 40 years of age with post-stroke dysphagia
* Patients with Functional Oral Intake Scale (FOAS) 1-6

Exclusion Criteria:

* Patients younger than 40 years old
* Dementia, impaired consciousness or hypoesthetic /anesthetic patients
* Patients with low body mass
* Patients with pacemakers and severe heart disease
* Severe hypertension and hypotension
* Thrombosis or thrombophlebitis
* Pregnancy
* Epilepsy

Primary outcomes:
measure: Ultrasonographic measurements
timeFrame: at baseline, 4th week
Secondary outcomes:
measure: Functional Oral Intake Scale (FOIS)
timeFrame: at baseline, 4th week
measure: Swallowing Function Screening Test (EAT-10)
timeFrame: at baseline, 4th week
measure: GUSS (Gagging Swallowing Screening Test)
timeFrame: at baseline, 4th week
measure: Modified Mann Swallowing Ability Assessment Test (MMASA)
timeFrame: at baseline, 4th week
measure: SWAL-QOL (The impact of swallowing disorders on quality of life questionnaire)
timeFrame: at baseline, 4th week
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: health sciences university Kayseri medicine faculty
Study officials:
affiliation: Kayseri City Hospital
name: Neslihan YAĞMUR GÖZ
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Konecny P, Elfmark M. Electrical stimulation of hyoid muscles in post-stroke dysphagia. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2018 Mar;162(1):40-42. doi: 10.5507/bp.2017.043. Epub 2017 Nov 2.
citation: Lim KB, Lee HJ, Lim SS, Choi YI. Neuromuscular electrical and thermal-tactile stimulation for dysphagia caused by stroke: a randomized controlled trial. J Rehabil Med. 2009 Feb;41(3):174-8. doi: 10.2340/16501977-0317.
citation: Oh DH, Park JS, Kim HJ, Chang MY, Hwang NK. The effect of neuromuscular electrical stimulation with different electrode positions on swallowing in stroke patients with oropharyngeal dysphagia: A randomized trial. J Back Musculoskelet Rehabil. 2020;33(4):637-644. doi: 10.3233/BMR-181133.
citation: Robbins J, Kays SA, Gangnon RE, Hind JA, Hewitt AL, Gentry LR, Taylor AJ. The effects of lingual exercise in stroke patients with dysphagia. Arch Phys Med Rehabil. 2007 Feb;88(2):150-8. doi: 10.1016/j.apmr.2006.11.002.