StrokeNCT05832658
Efficacy of Game-Based EMG-Biofeedback Therapy in Post-Stroke Dysphagia
A study testing With EMG-Biofeedback and Without EMG-Biofeedback in people with Stroke and Dysphagia, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the effectiveness of game-based biofeedback application via surface electromyography in patients with post-stroke dysphagia. The same treatment interventions will be applied with and without biofeedback, and thus the contribution of adding biofeedback to the treatment will be determined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Dysphagia, Surface Electromyography
- What is being tested?
- With EMG-Biofeedback and Without EMG-Biofeedback
- 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
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 May 2023to 14 Oct 2023
- 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
- History of hemorrhagic or ischemic stroke longer than 3 months
- Being over the age of eighteen
- Level ≤ 6 on the Functional Oral Intake Scale (FOIS)
- Post-stroke onset of swallowing complaints
- Ability to communicate with the patient and carry out the given commands
- Mini mental test evaluation ≥ 24 points
Show all 9Show fewer
- Absence of concomitant serious systemic disease (unregulated hypertension, decompensated heart failure, malignancy, infection, pacemaker, epilepsy, etc.)
- Detection of pathology in the oropharyngeal phase of swallowing in videofluoroscopic evaluation
- Not taking any swallowing-related treatment in the last 3 months
Who cannot join
- History of neoplastic disease and/or radiotherapy to the head and neck region
- Having additional musculoskeletal disease or non-stroke neurologic disease that may cause swallowing disorders
- Unable to communicate or carry out commands
- Inability to maintain head-holding balance
- Patients with severe pathology in bolus formation or delivery of the bolus to the pharynx during the oral swallowing phase
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to determine the effectiveness of game-based biofeedback application via surface electromyography in patients with post-stroke dysphagia. The same treatment interventions will be applied with and without biofeedback, and thus the contribution of adding biofeedback to the treatment will be determined.
- Conditions
- Stroke, Dysphagia, Surface Electromyography, Biofeedback, Swallowing Disorder
- Being tested
- With EMG-Biofeedback, Without EMG-Biofeedback, Usual Care
- 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.
With EMG-BiofeedbackDevice
Once a day for a total of 15 sessions, the Mendelsohn maneuver will be performed for 15 minutes and the effortful swallow maneuver will be performed for 15 minutes with game-based emg-biofeedback.
Without EMG-BiofeedbackBehavioural
Once a day for a total of 15 sessions, the Mendelsohn maneuver will be performed for 15 minutes and the effortful swallow maneuver will be performed for 15 minutes with only verbal feedback.
Usual CareBehavioural
Patient and family education will be provided by the investigator. In addition, each patient will be evaluated and oral motor exercises and thermal tactile stimulation will be given to each patient when necessary.
| Study group | Role | What they receive |
|---|---|---|
| EMG-Biofeedback | Experimental | Mendelsohn maneuver and effortful swallow exercise will be applied through game-based emg-biofeedback to patients with post-stroke dysphagia. Receives: Device: With EMG-Biofeedback; Behavioral: Usual Care |
| Classic Therapy | Active comparator | Mendelsohn maneuver and effortful swallow exercise with only verbal feedback will be applied to patients with post-stroke dysphagia. Receives: Behavioral: Without EMG-Biofeedback; Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gugging Swallowing Screen (GUSS)
It is used to determine the severity of dysphagia and the risk of aspiration in patients with acute stroke. It is evaluated out of 20 points. It recommends videofluoroscopy as an advanced examination for patients with a score of less than 20.
Measured: From baseline to the end of the treatment ( 3 week)
Functional Oral Intake Scale (FOIS)
7 point scale from 1-7. Higher number indicated increased amount and normality of oral intake.
Measured: From baseline to the end of the treatment ( 3 week)
Penetration Aspiration Scale (PAS)
Videofluoroscopic evaluation is performed. It is an 8-point scale. The higher the number, the greater the increase in penetration/aspiration. 1 means no penetration and no aspiration. 8 means there is aspiration and there is no patient response.
Measured: From baseline to the end of the treatment ( 3 week)
Functional Dysphagia Scale (FDS)
Videofluoroscopic evaluation is performed. It is a total of 100 points scale. A higher score indicates more severe dysphagia.
Measured: From baseline to the end of the treatment ( 3 week)
Dysphagia Outcome and Severity Scale (DOSS)
Videofluoroscopic evaluation is performed. It is a 7-point scale. A score of 6 and 7 represents normal swallowing, a score of 5 represents mild dysphagia, a score of 2 to 4 represents moderate dysphagia, and a score of 1 represents severe dysphagia.
Measured: From baseline to the end of the treatment ( 3 week)
Dysphagia Handicap Index (DHI)
Dysphagia Handicap Index (DHI) is a self-assessment questionnaire which consists of 25 statements to examine three aspects of dysphagia patients' quality of life (QoL): functional, physical, and emotional. The patient can get a maximum score of 100 points.A higher score indicates a more severe swallowing disorder.
Measured: From baseline to the end of the treatment ( 3 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start7 May 2023
- Primary completion14 Oct 2023
- Study completion14 Oct 2023
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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bulent Alyanak, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832658
- Sponsor's protocol ID
- E-68869993-000-1019202
- Status last verified
- Jan 2024
- First submitted
- 16 Apr 2023
- Last updated
- 23 Jan 2024
- 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 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Game-Based EMG-Biofeedback Therapy in Post-Stroke Dysphagia
- ClinicalTrials.gov ID
- NCT05832658
- Acronym / sponsor ID
- E-68869993-000-1019202
- Conditions
- Stroke, Dysphagia, Surface Electromyography, Biofeedback, Swallowing Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 7 May 2023 (actual)
- Primary completion
- 14 Oct 2023 (actual)
- Study completion
- 14 Oct 2023 (actual)
- First posted
- 27 Apr 2023 (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.
This study aims to determine the effectiveness of game-based biofeedback application via surface electromyography in patients with post-stroke dysphagia. The same treatment interventions will be applied with and without biofeedback, and thus the contribution of adding biofeedback to the treatment will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMG-Biofeedback | Experimental | Device: With EMG-Biofeedback, Behavioral: Usual CareMendelsohn maneuver and effortful swallow exercise will be applied through game-based emg-biofeedback to patients with post-stroke dysphagia. |
| Classic Therapy | Active comparator | Behavioral: Without EMG-Biofeedback, Behavioral: Usual CareMendelsohn maneuver and effortful swallow exercise with only verbal feedback will be applied to patients with post-stroke dysphagia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- History of hemorrhagic or ischemic stroke longer than 3 months
- Being over the age of eighteen
- Level ≤ 6 on the Functional Oral Intake Scale (FOIS)
- Post-stroke onset of swallowing complaints
- Ability to communicate with the patient and carry out the given commands
Key exclusion criteria (5 listed)
- History of neoplastic disease and/or radiotherapy to the head and neck region
- Having additional musculoskeletal disease or non-stroke neurologic disease that may cause swallowing disorders
- Unable to communicate or carry out commands
- Inability to maintain head-holding balance
- Patients with severe pathology in bolus formation or delivery of the bolus to the pharynx during the oral swallowing phase
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 |
|---|---|---|
| With EMG-BiofeedbackOnce a day for a total of 15 sessions, the Mendelsohn maneuver will be performed for 15 minutes and the effortful swallow maneuver will be performed for 15 minutes with game-based emg-biofeedback. | Device | EMG-Biofeedback |
| Without EMG-BiofeedbackOnce a day for a total of 15 sessions, the Mendelsohn maneuver will be performed for 15 minutes and the effortful swallow maneuver will be performed for 15 minutes with only verbal feedback. | Behavioural | Classic Therapy |
| Usual CarePatient and family education will be provided by the investigator. In addition, each patient will be evaluated and oral motor exercises and thermal tactile stimulation will be given to each patient when necessary. | Behavioural | Classic Therapy, EMG-Biofeedback |
Primary outcome
Gugging Swallowing Screen (GUSS)
Time frame: From baseline to the end of the treatment ( 3 week)
It is used to determine the severity of dysphagia and the risk of aspiration in patients with acute stroke. It is evaluated out of 20 points. It recommends videofluoroscopy as an advanced examination for patients with a score of less than 20.
Functional Oral Intake Scale (FOIS)
Time frame: From baseline to the end of the treatment ( 3 week)
7 point scale from 1-7. Higher number indicated increased amount and normality of oral intake.
Penetration Aspiration Scale (PAS)
Time frame: From baseline to the end of the treatment ( 3 week)
Videofluoroscopic evaluation is performed. It is an 8-point scale. The higher the number, the greater the increase in penetration/aspiration. 1 means no penetration and no aspiration. 8 means there is aspiration and there is no patient response.
Functional Dysphagia Scale (FDS)
Time frame: From baseline to the end of the treatment ( 3 week)
Videofluoroscopic evaluation is performed. It is a total of 100 points scale. A higher score indicates more severe dysphagia.
Dysphagia Outcome and Severity Scale (DOSS)
Time frame: From baseline to the end of the treatment ( 3 week)
Videofluoroscopic evaluation is performed. It is a 7-point scale. A score of 6 and 7 represents normal swallowing, a score of 5 represents mild dysphagia, a score of 2 to 4 represents moderate dysphagia, and a score of 1 represents severe dysphagia.
Dysphagia Handicap Index (DHI)
Time frame: From baseline to the end of the treatment ( 3 week)
Dysphagia Handicap Index (DHI) is a self-assessment questionnaire which consists of 25 statements to examine three aspects of dysphagia patients' quality of life (QoL): functional, physical, and emotional. The patient can get a maximum score of 100 points.A higher score indicates a more severe swallowing disorder.
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 Jan 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With EMG-Biofeedback and Without EMG-Biofeedback in people with Stroke and Dysphagia, run by Kocaeli 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 9 inclusion and 5 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 Jan 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?
Gugging Swallowing Screen (GUSS) (time frame: From baseline to the end of the treatment ( 3 week)). The study lists 6 primary outcomes in all. 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 Jan 2024.