Effect of Superficial Neuromuscular Stimulation in Post-stroke Dysphagic Patients.

NCT06321406 | Completed

• 1 other identifier: KayseriCHdysphagia
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia; Stroke

Keywords

dysphagia; post-stroke dysphagia; rehabilitation; ultrasonography

Outcome Measures

Primary Outcomes (1)

• Ultrasonographic measurements

  Measurements made by ultrasonography (measurement of tongue thickness, measurement of hyoid-larynx distance and measurements of other anatomical structures)

  at baseline, 4th week

Secondary Outcomes (5)

• Functional Oral Intake Scale (FOIS)

  at baseline, 4th week

• Swallowing Function Screening Test (EAT-10)

  at baseline, 4th week

• GUSS (Gagging Swallowing Screening Test)

  at baseline, 4th week

• Modified Mann Swallowing Ability Assessment Test (MMASA)

  at baseline, 4th week

• SWAL-QOL (The impact of swallowing disorders on quality of life questionnaire)

  at baseline, 4th week

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Behavioral: Exercise

NMES(neuromuscular electrical stimulation) Group

ACTIVE COMPARATOR

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 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.

Device: NMES (neuromuscular electrical stimulation); Behavioral: Exercise

Interventions

NMES (neuromuscular electrical stimulation) DEVICE

With this application, swallowing muscles are stimulated and muscle strength increases.

NMES(neuromuscular electrical stimulation) Group

Exercise BEHAVIORAL

Traditional Conservative swallowing treatment

Control Group; NMES(neuromuscular electrical stimulation) Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

health sciences university Kayseri medicine faculty

Kayseri, 38080, Turkey (Türkiye)

Location

Related Publications (9)

• Cook IJ, Kahrilas PJ. AGA technical review on management of oropharyngeal dysphagia. Gastroenterology. 1999 Feb;116(2):455-78. doi: 10.1016/s0016-5085(99)70144-7. No abstract available.

  PMID: 9922328 BACKGROUND

• Kuhl V, Eicke BM, Dieterich M, Urban PP. Sonographic analysis of laryngeal elevation during swallowing. J Neurol. 2003 Mar;250(3):333-7. doi: 10.1007/s00415-003-1007-2.

  PMID: 12638025 BACKGROUND

• Bath PM, Lee HS, Everton LF. Swallowing therapy for dysphagia in acute and subacute stroke. Cochrane Database Syst Rev. 2018 Oct 30;10(10):CD000323. doi: 10.1002/14651858.CD000323.pub3.

  PMID: 30376602 BACKGROUND

• Simonelli M, Ruoppolo G, Iosa M, Morone G, Fusco A, Grasso MG, Gallo A, Paolucci S. A stimulus for eating. The use of neuromuscular transcutaneous electrical stimulation in patients affected by severe dysphagia after subacute stroke: A pilot randomized controlled trial. NeuroRehabilitation. 2019;44(1):103-110. doi: 10.3233/NRE-182526.

  PMID: 30714980 BACKGROUND

• Chiang CF, Lin MT, Hsiao MY, Yeh YC, Liang YC, Wang TG. Comparative Efficacy of Noninvasive Neurostimulation Therapies for Acute and Subacute Poststroke Dysphagia: A Systematic Review and Network Meta-analysis. Arch Phys Med Rehabil. 2019 Apr;100(4):739-750.e4. doi: 10.1016/j.apmr.2018.09.117. Epub 2018 Oct 21.

  PMID: 30352222 BACKGROUND

• 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.

  PMID: 29097820 BACKGROUND

• 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.

  PMID: 19229451 BACKGROUND

• 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.

  PMID: 31594198 BACKGROUND

• 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.

  PMID: 17270511 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Neslihan YAĞMUR GÖZ

  Kayseri City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 20, 2024
• Study Start: April 15, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 3, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-06

Locations

TU (1)