StrokeNCT04421937
The Effects of Neuromuscular Electrical Stimulation on Swallowing Functions in Stroke Patients With Dysphagia
A study testing Procedure: Traditional Dysphagia Therapy (TDT) and Procedure: Neuromuscular Electrical Stimulation with TDT in people with Stroke and Swallowing Disorder, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In our study, our aim is to evaluate the effect of neuromuscular electrical stimulation added to traditional dysphagia therapy in stroke patients with dysphagia, on functional oral intake status, dysphagia-related symptoms, quality of life, and complications related to dysphagia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Swallowing Disorder, Dysphagia
- What is being tested?
- Procedure: Traditional Dysphagia Therapy (TDT) and Procedure: Neuromuscular Electrical Stimulation with TDT
- 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
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2020to 16 Feb 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- After the first week after a stroke, detecting dysphagia by using bedside water assessment test
- Lesion location is shown by MRI or CT
- Unsupported sitting balance
- The score of Mini-mental state examination test (MMSE) 20 and above
- Over 18 years old
Who cannot join
- Global aphasia or cognitive disorders that may affect the understanding of the instructions
- Patients with major medical problems that may affect participation
- Tracheostomy presence
- Previous neck surgery
- To have received radiotherapy in the head or neck area
- Presence of a cardiac pacemaker or a history of epilepsy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Fatih, 34093
About this study
Official title: The Effects of Neuromuscular Electrical Stimulation on Swallowing Functions in Stroke Patients With Dysphagia: Randomized Controlled Trial
In our study, our aim is to evaluate the effect of neuromuscular electrical stimulation added to traditional dysphagia therapy in stroke patients with dysphagia, on functional oral intake status, dysphagia-related symptoms, quality of life, and complications related to dysphagia.
- Being tested
- Procedure: Traditional Dysphagia Therapy (TDT), Procedure: Neuromuscular Electrical Stimulation with TDT
- Keywords
- stroke, swallowing disorder, dysphagia, stroke rehabilitation, neuromuscular electrical stimulation, traditional dysphagia therapy
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: Traditional Dysphagia Therapy (TDT)Behavioural
Traditional dysphagia therapy includes diet modification training, teaching postural compensatory methods, training of oral motor control exercises and tongue root exercises, training of swallowing maneuvers, and practice of chin-resistance exercise, which is the exercise of opening the upper esophageal sphincter.
Traditional Dysphagia Therapy will be applied for 45 minutes a day, 5 days a week for 3 weeks.
Procedure: Neuromuscular Electrical Stimulation with TDTDevice
The skin to be treated will be cleaned and dried. NMES will be implemented with signals received from two channels. In the first channel, the upper electrodes will be placed horizontally just above the hyoid bone. This is the place where the cupping is felt when the finger is pressed right under the chin. In the second channel, the lower electrodes will be placed horizontally, just above the thyrohyoid muscle. This is the place where you can feel a cupping when pressed with your finger, on both sides of the apple in the larynx. The device will be set to start at the lowest power, with very short pulses of approximately 700 microseconds, at intervals of 1 second. The power will be gradually increased according to the device and the power that the patient feels vibration will be stopped. The power to be applied will not exceed 25 milliamps. NMES application and Traditional Dysphagia Therapy will be applied for 45 minutes a day, 5 days a week for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular Electrical Stimulation (NMES) with TDT | Experimental | Not described Receives: Device: Procedure: Neuromuscular Electrical Stimulation with TDT |
| Traditional Dysphagia Therapy (TDT) | Active comparator | Not described Receives: Behavioral: Procedure: Traditional Dysphagia Therapy (TDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Oral Intake Scale (FOIS)
Functional Oral Intake Scale (FOIS) is a scale that shows the functional oral intake of patients with dysphagia. FOIS used for evaluation is a two part scale consisting of 7 levels. It is used to show whether the individual is dependent on the feeding tube and the level of oral intake. On this scale, 7 shows the best and 1 shows the worst functional oral intake. The change in FOIS will be our primary outcome measure in our research. It has been evaluated as an appropriate tool to demonstrate the change in functional oral intake in stroke patients. It is suitable as an independent measure of functional oral intake in prospective studies of stroke-related dysphagia.
Measured: before intervention, immediately after intervention, 3 months after the intervention
Secondary outcomes (6)
Change in Eating Assessment Tool-10 (EAT-10) Score
Eating Assessment Tool-10 (EAT-10) is used to assess participants' dysphagia symptoms, symptom severity, and risk of oropharyngeal dysphagia. This scale is a scale of 10 questions that the patient himself answers, which questions the symptoms of dysphagia. The answer points for each question range from 0 (no problem) to 4 (serious problem). If EAT-10 score is ≥3, it is considered as "risk of oropharyngeal dysphagia". It is a useful tool to evaluate the severity of dysphagia symptom in the clinic, to monitor the progression and effectiveness of the disease.
Measured: before intervention, immediately after intervention, 3 months after the intervention
Change in Swallowing-related Quality of Life (SWAL-QOL) Score
Swallowing-related quality of life scale (SWAL-QOL) is used to evaluate the effect of swallowing disorders on quality of life. It was created to evaluate the quality of life of patients with oropharyngeal dysphagia. It includes a total of 44 questions under eating disorder, eating time, eating desire, food selection, communication, anxiety, mental health, social functionality, fatigue, and sleep subgroups. Each question is evaluated with a score ranging from 1 (worst) to 5 (best). The subgroup scores of the scale and the total score of the scale can be used to assess the change in patients.
Measured: before intervention, immediately after intervention, 3 months after the intervention
Change in Visual Analog Scale (VAS)
Patients' difficulty in swallowing will be questioned using the Visual Analogue Scale (VAS). On a scale of ten centimeters, patients will be asked to mark the appropriate level of dysphagia 0: No dysphagia, 10: Very severe dysphagia.
Measured: before intervention, immediately after intervention, 3 months after the intervention
Change in Laryngostroboscopy Examination
In the Istanbul Faculty of Medicine Otorhinolaryngology Diseases Clinic, evaluations will be made by the Ear Nose Throat Specialist. Whether there is vocal cord paresis and paralysis and whether glottic patency is evaluated in the laryngostroboscopic examination.
Measured: before intervention, immediately after intervention
Change in Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Fiberoptic endoscopic swallowing assessment will be performed by the otolaryngologist doctor before and immediately after the treatment. In the fiberoptic endoscopic swallowing assessment, the condition of the patient according to the penetration aspiration scale will be checked. Grade 1 represents the best and grade 7 the worst on the penetration aspiration scale.
Measured: before intervention, immediately after intervention
Change in Voice-Related Quality of Life (V-RQOL) Score
This ten-item scale is a scale designed for adult populations with voice disorders to measure both social-emotional and physical-functional aspects of voice problems. The answer points for each question range from 1 (few problems) to 5 (serious problems). A total score change on this scale will be used to evaluate patients.
Measured: before intervention, immediately after intervention, 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start15 Apr 2020
- Primary completion30 Jan 2022
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Tarihçi, Istanbul University
- Investigators
- Elif Tarihçi, MD, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421937
- Sponsor's protocol ID
- Istanbul University, Istanbul
- Status last verified
- Aug 2022
- First submitted
- 16 May 2020
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Neuromuscular Electrical Stimulation on Swallowing Functions in Stroke Patients With Dysphagia: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04421937
- Acronym / sponsor ID
- Istanbul University, Istanbul
- Keywords
- stroke, swallowing disorder, dysphagia, stroke rehabilitation, neuromuscular electrical stimulation, traditional dysphagia therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 9 Jun 2020 (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.
In our study, our aim is to evaluate the effect of neuromuscular electrical stimulation added to traditional dysphagia therapy in stroke patients with dysphagia, on functional oral intake status, dysphagia-related symptoms, quality of life, and complications related to dysphagia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular Electrical Stimulation (NMES) with TDT | Experimental | Device: Procedure: Neuromuscular Electrical Stimulation with TDT |
| Traditional Dysphagia Therapy (TDT) | Active comparator | Behavioral: Procedure: Traditional Dysphagia Therapy (TDT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- After the first week after a stroke, detecting dysphagia by using bedside water assessment test
- Lesion location is shown by MRI or CT
- Unsupported sitting balance
- The score of Mini-mental state examination test (MMSE) 20 and above
- Over 18 years old
Key exclusion criteria (6 listed)
- Global aphasia or cognitive disorders that may affect the understanding of the instructions
- Patients with major medical problems that may affect participation
- Tracheostomy presence
- Previous neck surgery
- To have received radiotherapy in the head or neck area
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 |
|---|---|---|
| Procedure: Traditional Dysphagia Therapy (TDT)Traditional dysphagia therapy includes diet modification training, teaching postural compensatory methods, training of oral motor control exercises and tongue root exercises, training of swallowing maneuvers, and practice of chin-resistance exercise, which is the exercise of opening the upper esophageal sphincter. Traditional Dysphagia Therapy will be applied for 45 minutes a day, 5 days a week for 3 weeks. | Behavioural | Traditional Dysphagia Therapy (TDT) |
| Procedure: Neuromuscular Electrical Stimulation with TDTThe skin to be treated will be cleaned and dried. NMES will be implemented with signals received from two channels. In the first channel, the upper electrodes will be placed horizontally just above the hyoid bone. This is the place where the cupping is felt when the finger is pressed right under the chin. In the second channel, the lower electrodes will be placed horizontally, just above the thyrohyoid muscle. This is the place where you can feel a cupping when pressed with your finger, on both sides of the apple in the larynx. The device will be set to start at the lowest power, with very short pulses of approximately 700 microseconds, at intervals of 1 second. The power will be gradually increased according to the device and the power that the patient feels vibration will be stopped. The power to be applied will not exceed 25 milliamps. NMES application and Traditional Dysphagia Therapy will be applied for 45 minutes a day, 5 days a week for 3 weeks. | Device | Neuromuscular Electrical Stimulation (NMES) with TDT |
Primary outcome
Change in Functional Oral Intake Scale (FOIS)
Time frame: before intervention, immediately after intervention, 3 months after the intervention
Functional Oral Intake Scale (FOIS) is a scale that shows the functional oral intake of patients with dysphagia. FOIS used for evaluation is a two part scale consisting of 7 levels. It is used to show whether the individual is dependent on the feeding tube and the level of oral intake. On this scale, 7 shows the best and 1 shows the worst functional oral intake. The change in FOIS will be our primary outcome measure in our research. It has been evaluated as an appropriate tool to demonstrate the change in functional oral intake in stroke patients. It is suitable as an independent measure of functional oral intake in prospective studies of stroke-related dysphagia.
6 secondary outcomes
Change in Eating Assessment Tool-10 (EAT-10) Score
Time frame: before intervention, immediately after intervention, 3 months after the intervention
Change in Swallowing-related Quality of Life (SWAL-QOL) Score
Time frame: before intervention, immediately after intervention, 3 months after the intervention
Change in Visual Analog Scale (VAS)
Time frame: before intervention, immediately after intervention, 3 months after the intervention
Change in Laryngostroboscopy Examination
Time frame: before intervention, immediately after intervention
Change in Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Time frame: before intervention, immediately after intervention
Change in Voice-Related Quality of Life (V-RQOL) Score
Time frame: before intervention, immediately after intervention, 3 months after the intervention
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 23 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Elif Tarihçi, MD principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: Traditional Dysphagia Therapy (TDT) and Procedure: Neuromuscular Electrical Stimulation with TDT in people with Stroke and Swallowing Disorder, run by Istanbul University 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 5 inclusion and 6 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 23 Aug 2022. 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?
Change in Functional Oral Intake Scale (FOIS) (time frame: before intervention, immediately after intervention, 3 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2022.