DysphagiaNCT06321406
Effect of Superficial Neuromuscular Stimulation in Post-stroke Dysphagic Patients.
A study testing NMES (neuromuscular electrical stimulation) and Exercise in people with Dysphagia and Stroke, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- What is being tested?
- NMES (neuromuscular electrical stimulation) and Exercise
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2024to 3 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients over 40 years of age with post-stroke dysphagia
- Patients with Functional Oral Intake Scale (FOAS) 1-6
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
health sciences university Kayseri medicine faculty
Kayseri, 38080
About this study
Official title: Effect of Superficial Neuromuscular Stimulation on Ultrasonographic Findings of Oropharyngeal Swallowing in Post-stroke Dysphagic Patients.
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.
Read the detailed description
A randomized, prospective, controlled study will include 10 patients with post-stroke dysphagia. Groups will be randomized into 2 groups.
- 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.
- 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
- Being tested
- NMES (neuromuscular electrical stimulation), Exercise
- Keywords
- dysphagia, post-stroke dysphagia, rehabilitation, ultrasonography
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMES (neuromuscular electrical stimulation)Device
With this application, swallowing muscles are stimulated and muscle strength increases.
ExerciseBehavioural
Traditional Conservative swallowing treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: NMES (neuromuscular electrical stimulation); Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic measurements
Measurements made by ultrasonography (measurement of tongue thickness, measurement of hyoid-larynx distance and measurements of other anatomical structures)
Measured: at baseline, 4th week
Secondary outcomes (5)
Functional Oral Intake Scale (FOIS)
Functional Oral Intake Scale (FOIS) is an ordinal scale with validity and reliability designed to evaluate the current status and functional change in oral intake of patients with neurogenic dysphagia. This scale consists of 7 items. Items 1 to 3 are related to inability to feed orally, items 4 to 7 are related to oral feeding.
Measured: at baseline, 4th week
Swallowing Function Screening Test (EAT-10)
It is a useful questionnaire consisting of 10 questions with Turkish validity and reliability and which patients can easily fill out.
Measured: at baseline, 4th week
GUSS (Gagging Swallowing Screening Test)
GUSS is one of the approved swallowing screening tests in acute stroke patients. It provides dietary recommendations as well as screening for aspiration risk. It consists of two main parts; In the first part, conditions such as alertness, salivation, and cough are evaluated as an indirect swallowing test. In the second part, the direct swallowing test, swallowing trials are performed with three different consistencies: semi-solid, liquid and solid. 5 points are achieved in each subgroup. Scores between 0 and 9 are considered as severe dysphagia and special diet and videofluoroscopic examination are recommended. 10-14 points are considered moderate dysphagia, 5-19 points are considered mild dysphagia, and 20 points are considered normal.
Measured: at baseline, 4th week
Modified Mann Swallowing Ability Assessment Test (MMASA)
It is a bedside test that evaluates parameters such as alertness, cooperation, respiration, expressive speech, auditory perception, dysarthria, salivation, tongue movement, tongue strength, gagging, cough reflex and palate movement. The highest score is 100. It is recommended that patients who score 94 or below as a result of the evaluation should not be fed orally and should be referred to a speech-language pathologist.
Measured: at baseline, 4th week
SWAL-QOL (The impact of swallowing disorders on quality of life questionnaire)
Swallow Quality of Life Questionnaire (SWAL-QOL) is one of the most widely known patient based and dysphagia specific item questionnaire. It is a valid and reliable scale in the evaluation of dysphagia.
Measured: at baseline, 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start15 Apr 2024
- Primary completion1 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Havva Talay Çalış, Kayseri City Hospital
- Investigators
- Neslihan YAĞMUR GÖZ, Principal investigator, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321406
- Sponsor's protocol ID
- KayseriCHdysphagia
- Status last verified
- Jun 2024
- First submitted
- 14 Mar 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 9922328Kuhl 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.
PubMed 12638025Bath 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.
PubMed 30376602Simonelli 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.
PubMed 30714980Chiang 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.
PubMed 30352222Konecny 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.
PubMed 29097820Lim 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.
PubMed 19229451Oh 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.
PubMed 31594198Robbins 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.
PubMed 17270511
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Superficial Neuromuscular Stimulation on Ultrasonographic Findings of Oropharyngeal Swallowing in Post-stroke Dysphagic Patients.
- ClinicalTrials.gov ID
- NCT06321406
- Acronym / sponsor ID
- KayseriCHdysphagia
- Keywords
- dysphagia, post-stroke dysphagia, rehabilitation, ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: ExerciseExercises 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. |
| NMES(neuromuscular electrical stimulation) Group | Active comparator | Device: NMES (neuromuscular electrical stimulation), Behavioral: ExerciseOne 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female patients over 40 years of age with post-stroke dysphagia
- Patients with Functional Oral Intake Scale (FOAS) 1-6
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMES (neuromuscular electrical stimulation)With this application, swallowing muscles are stimulated and muscle strength increases. | Device | NMES(neuromuscular electrical stimulation) Group |
| ExerciseTraditional Conservative swallowing treatment | Behavioural | Control Group, NMES(neuromuscular electrical stimulation) Group |
Primary outcome
Ultrasonographic measurements
Time frame: at baseline, 4th week
Measurements made by ultrasonography (measurement of tongue thickness, measurement of hyoid-larynx distance and measurements of other anatomical structures)
5 secondary outcomes
Functional Oral Intake Scale (FOIS)
Time frame: at baseline, 4th week
Swallowing Function Screening Test (EAT-10)
Time frame: at baseline, 4th week
GUSS (Gagging Swallowing Screening Test)
Time frame: at baseline, 4th week
Modified Mann Swallowing Ability Assessment Test (MMASA)
Time frame: at baseline, 4th week
SWAL-QOL (The impact of swallowing disorders on quality of life questionnaire)
Time frame: at baseline, 4th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Background: PubMed 9922328Cook 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.
- Background: PubMed 12638025Kuhl 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.
- Background: PubMed 30376602Bath 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.
- Background: PubMed 30714980Simonelli 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.
- Background: PubMed 30352222Chiang 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.
- Background: PubMed 29097820Konecny 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.
- Background: PubMed 19229451Lim 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.
- Background: PubMed 31594198Oh 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.
- Background: PubMed 17270511Robbins 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neslihan YAĞMUR GÖZ principal investigator
Kayseri City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES (neuromuscular electrical stimulation) and Exercise in people with Dysphagia and Stroke, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 5 Jun 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonographic measurements (time frame: at baseline, 4th week). 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 NCT06321406, which also lists 9 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 5 Jun 2024.