PARKINSON DISEASE (Disorder)NCT07906028
Effortful Swallow Exercise With Visual Biofeedback for Tongue Strength in Parkinson's Disease
A study testing Effortful swallow exercise with visual biofeedback and Effortful swallow exercise without visual biofeedback in people with PARKINSON DISEASE (Disorder) and Dysphagia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn whether adding visual biofeedback to an effortful swallow exercise program improves tongue strength and swallowing function in adults with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Dysphagia
- What is being tested?
- Effortful swallow exercise with visual biofeedback and Effortful swallow exercise without visual biofeedback
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Sep 2024to 26 Jun 2025
- 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
- Age 18 years or older
- Neurologist-confirmed diagnosis of idiopathic Parkinson's disease
- Stage 1 to 3 on the Modified Hoehn and Yahr Scale
- Montreal Cognitive Assessment (MoCA) score of 21 or higher
- Able to understand and follow study instructions
Who cannot join
- History of head and neck cancer
- Neurological disorder other than idiopathic Parkinson's disease
- Stage 4 or 5 on the Modified Hoehn and Yahr Scale
- Previous deep brain stimulation
- Cognitive impairment interfering with understanding study instructions
- Speech, language, or swallowing therapy within the previous 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Istanbul Training and Research Hospital
Istanbul
About this study
Official title: Effects of Iowa Oral Performance Instrument (IOPI) Visual Biofeedback During Effortful Swallow Exercise on Tongue Strength and Endurance, Suprahyoid Muscle Activity, and Swallowing-Related Quality of Life in Individuals With Parkinson's Disease: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether adding visual biofeedback to an effortful swallow exercise program improves tongue strength and swallowing function in adults with Parkinson's disease.
The main questions it aims to answer are:
Read more
- Does effortful swallow exercise with visual biofeedback increase tongue strength and tongue endurance more than the same exercise without visual biofeedback?
- Does visual biofeedback lead to greater improvements in swallowing pressure, swallowing muscle activity, swallowing symptoms, and swallowing-related quality of life?
Researchers compared two groups that performed the same effortful swallow exercise program. In one group, participants saw real-time feedback on a tongue pressure device (Iowa Oral Performance Instrument, IOPI) showing when they reached their target swallowing effort. In the other group, participants did the same exercises with verbal instructions only and did not see the device display.
Participants:
- Attended supervised exercise sessions with a speech-language therapist 3 times a week for 4 weeks (12 sessions in total)
- Performed repeated hard saliva swallows in each session, with rest breaks between sets
- Completed tongue pressure tests, a surface electromyography test of the muscles under the chin, and swallowing questionnaires before the program and within one week after it ended.
Read the detailed description
This single-center, randomized, parallel-group study was conducted at the Neurology Clinic of University of Health Sciences Istanbul Training and Research Hospital. Adults with idiopathic Parkinson's disease (Modified Hoehn and Yahr stages 1-3) were randomly assigned to one of two groups using a computer-generated block randomization sequence.
Both groups received supervised effortful swallow therapy three times per week for four consecutive weeks (12 sessions). Each session consisted of five sets separated by 2-minute rest intervals. Participants performed 16 effortful saliva swallows per set at 15-second intervals during the first two weeks and 20 effortful swallows per set at 10-second intervals during the final two weeks. The IOPI bulb was positioned at the posterior tongue throughout the intervention in both groups. Correct execution of each swallow was confirmed by observation of hyolaryngeal movement.
In the visual biofeedback group, the IOPI was operated in Target Mode, with the target set at 80% of each participant's baseline maximum posterior tongue pressure; participants received real-time visual feedback when the target was reached. In the non-biofeedback group, the IOPI was operated in Peak Mode and the display was visible only to the therapist; participants received identical verbal instructions without visual feedback.
All assessments were performed during the ON phase of antiparkinsonian medication, at baseline and within one week after completion of the intervention. Surface electromyography assessments were performed by a neurologist blinded to group allocation.
- Conditions
- PARKINSON DISEASE (Disorder), Dysphagia
- Being tested
- Effortful swallow exercise with visual biofeedback, Effortful swallow exercise without visual biofeedback
- Keywords
- efforful swallow, biofeedback, tongue strength, Iowa Oral Performance Instrument, Swallowing Exercise
- Medical subject headings
- Parkinson Disease, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effortful swallow exercise with visual biofeedbackBehavioural
Supervised effortful saliva swallow exercise delivered by a speech-language therapist. Each session included five sets with 2-minute rest intervals: 16 swallows per set at 15-second intervals in weeks 1-2, and 20 swallows per set at 10-second intervals in weeks 3-4. The IOPI bulb was placed at the posterior tongue. The IOPI was operated in Target Mode at 80% of baseline maximum posterior tongue pressure, and participants received real-time visual feedback when the target was reached. Correct swallow execution was confirmed by observation of hyolaryngeal movement.
Effortful swallow exercise without visual biofeedbackBehavioural
Identical supervised effortful saliva swallow exercise protocol (same frequency, duration, sets, repetitions, intervals, and posterior tongue bulb placement). The IOPI was operated in Peak Mode, and the display was visible only to the therapist. Participants received standardized verbal instructions without visual feedback. Correct swallow execution was confirmed by observation of hyolaryngeal movement.
| Study group | Role | What they receive |
|---|---|---|
| Visual Biofeedback Group | Experimental | Participants performed supervised effortful swallow exercises 3 times per week for 4 weeks (12 sessions) with real-time visual biofeedback from the Iowa Oral Performance Instrument (IOPI) operated in Target Mode, with the target set at 80% of baseline maximum posterior tongue pressure. Receives: Behavioral: Effortful swallow exercise with visual biofeedback |
| Non-biofeedback Group | Active comparator | Participants performed the same supervised effortful swallow exercise program 3 times per week for 4 weeks (12 sessions). The IOPI was operated in Peak Mode with the display visible only to the therapist; participants received identical verbal instructions without visual biofeedback. Receives: Behavioral: Effortful swallow exercise without visual biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tongue Strength
Maximum anterior and posterior tongue pressure (kPa) measured with the Iowa Oral Performance Instrument (IOPI). Participants pressed the bulb against the hard palate as forcefully as possible for 3 seconds; three trials were performed at each location and the highest value was used. Higher values indicate greater tongue strength.
Measured: Baseline and within 1 week after completion of the 4-week intervention
Tongue Endurance
Anterior and posterior tongue endurance (seconds) measured with the IOPI as the time participants maintained 50% of their maximum tongue pressure. Three trials were performed at each location and the longest duration was used. Longer duration indicates greater endurance.
Measured: Baseline and within 1 week after completion of the 4-week intervention
Secondary outcomes (5)
Swallowing pressure
Typical and effortful swallowing pressures (kPa) measured with the IOPI bulb at the posterior tongue during 3 mL water swallows. The mean of three trials for each task was used. Higher values indicate greater tongue pressure during swallowing.
Measured: Baseline and within 1 week after completion of the 4-week intervention
Suprahyoid Muscle Activity
Peak amplitude (µV) of suprahyoid muscle activity during typical and effortful saliva swallows, measured by surface electromyography. The mean of three peak amplitude values for each task was used. Assessments were performed by a neurologist blinded to group allocation.
Measured: Baseline and within 1 week after completion of the 4-week intervention
Swallowing-Related Quality of Life (T-SWAL-QOL)
Turkish version of the Swallowing Quality of Life Questionnaire, a 44-item questionnaire assessing swallowing-related quality of life across 11 domains. Scores range from 0 to 100, with higher scores indicating better swallowing-related quality of life.
Measured: Baseline and within 1 week after completion of the 4-week intervention
Dysphagia Symptom Severity (T-EAT-10)
Turkish version of the Eating Assessment Tool, a 10-item self-report questionnaire. Each item is scored from 0 (no problem) to 4 (severe problem); total score ranges from 0 to 40, with higher scores indicating more severe swallowing symptoms. A score of 3 or higher indicates clinically relevant swallowing difficulty.
Measured: Baseline and within 1 week after completion of the 4-week intervention
Functional Oral Intake (FOIS)
Functional Oral Intake Scale, a 7-level scale rating oral intake from 1 (nothing by mouth) to 7 (total oral diet with no restrictions). Higher levels indicate better functional oral intake.
Measured: Baseline and within 1 week after completion of the 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start16 Sep 2024
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies 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
- Model description
- Participants were randomly assigned to one of two parallel groups: effortful swallow exercise with IOPI visual biofeedback or the same exercise without visual biofeedback.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Anadolu University
- Responsible party
- Principal investigator, Beyza PEHLIVAN BOZOGLU, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906028
- Sponsor's protocol ID
- 711716-2024
- Other IDs
- 2515
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 30 Oct 2026
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Iowa Oral Performance Instrument (IOPI) Visual Biofeedback During Effortful Swallow Exercise on Tongue Strength and Endurance, Suprahyoid Muscle Activity, and Swallowing-Related Quality of Life in Individuals With Parkinson's Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07906028
- Acronym / sponsor ID
- 711716-2024
- Conditions
- PARKINSON DISEASE (Disorder), Dysphagia
- Keywords
- efforful swallow, biofeedback, tongue strength, Iowa Oral Performance Instrument, Swallowing Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Anadolu University
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 30 Oct 2026 (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.
The goal of this clinical trial is to learn whether adding visual biofeedback to an effortful swallow exercise program improves tongue strength and swallowing function in adults with Parkinson's disease.
The main questions it aims to answer are:
- Does effortful swallow exercise with visual biofeedback increase tongue strength and tongue endurance more than the same exercise without visual biofeedback?
- Does visual biofeedback lead to greater improvements in swallowing pressure, swallowing muscle activity, swallowing symptoms, and swallowing-related quality of life?
Researchers compared two groups that performed the same effortful swallow exercise program. In one group, participants saw real-time feedback on a tongue pressure device (Iowa Oral Performance Instrument, IOPI) showing when they reached their target swallowing effort. In the other group, participants did the same exercises with verbal instructions only and did not see the device display.
Participants:
- Attended supervised exercise sessions with a speech-language therapist 3 times a week for 4 weeks (12 sessions in total)
- Performed repeated hard saliva swallows in each session, with rest breaks between sets
- Completed tongue pressure tests, a surface electromyography test of the muscles under the chin, and swallowing questionnaires before the program and within one week after it ended.
Detailed description
This single-center, randomized, parallel-group study was conducted at the Neurology Clinic of University of Health Sciences Istanbul Training and Research Hospital. Adults with idiopathic Parkinson's disease (Modified Hoehn and Yahr stages 1-3) were randomly assigned to one of two groups using a computer-generated block randomization sequence.
Both groups received supervised effortful swallow therapy three times per week for four consecutive weeks (12 sessions). Each session consisted of five sets separated by 2-minute rest intervals. Participants performed 16 effortful saliva swallows per set at 15-second intervals during the first two weeks and 20 effortful swallows per set at 10-second intervals during the final two weeks. The IOPI bulb was positioned at the posterior tongue throughout the intervention in both groups. Correct execution of each swallow was confirmed by observation of hyolaryngeal movement.
In the visual biofeedback group, the IOPI was operated in Target Mode, with the target set at 80% of each participant's baseline maximum posterior tongue pressure; participants received real-time visual feedback when the target was reached. In the non-biofeedback group, the IOPI was operated in Peak Mode and the display was visible only to the therapist; participants received identical verbal instructions without visual feedback.
All assessments were performed during the ON phase of antiparkinsonian medication, at baseline and within one week after completion of the intervention. Surface electromyography assessments were performed by a neurologist blinded to group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups: effortful swallow exercise with IOPI visual biofeedback or the same exercise without visual biofeedback.
| Arm | Type | Receives |
|---|---|---|
| Visual Biofeedback Group | Experimental | Behavioral: Effortful swallow exercise with visual biofeedbackParticipants performed supervised effortful swallow exercises 3 times per week for 4 weeks (12 sessions) with real-time visual biofeedback from the Iowa Oral Performance Instrument (IOPI) operated in Target Mode, with the target set at 80% of baseline maximum posterior tongue pressure. |
| Non-biofeedback Group | Active comparator | Behavioral: Effortful swallow exercise without visual biofeedbackParticipants performed the same supervised effortful swallow exercise program 3 times per week for 4 weeks (12 sessions). The IOPI was operated in Peak Mode with the display visible only to the therapist; participants received identical verbal instructions without visual biofeedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Neurologist-confirmed diagnosis of idiopathic Parkinson's disease
- Stage 1 to 3 on the Modified Hoehn and Yahr Scale
- Montreal Cognitive Assessment (MoCA) score of 21 or higher
- Able to understand and follow study instructions
Key exclusion criteria (6 listed)
- History of head and neck cancer
- Neurological disorder other than idiopathic Parkinson's disease
- Stage 4 or 5 on the Modified Hoehn and Yahr Scale
- Previous deep brain stimulation
- Cognitive impairment interfering with understanding study instructions
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 |
|---|---|---|
| Effortful swallow exercise with visual biofeedbackSupervised effortful saliva swallow exercise delivered by a speech-language therapist. Each session included five sets with 2-minute rest intervals: 16 swallows per set at 15-second intervals in weeks 1-2, and 20 swallows per set at 10-second intervals in weeks 3-4. The IOPI bulb was placed at the posterior tongue. The IOPI was operated in Target Mode at 80% of baseline maximum posterior tongue pressure, and participants received real-time visual feedback when the target was reached. Correct swallow execution was confirmed by observation of hyolaryngeal movement. | Behavioural | Visual Biofeedback Group |
| Effortful swallow exercise without visual biofeedbackIdentical supervised effortful saliva swallow exercise protocol (same frequency, duration, sets, repetitions, intervals, and posterior tongue bulb placement). The IOPI was operated in Peak Mode, and the display was visible only to the therapist. Participants received standardized verbal instructions without visual feedback. Correct swallow execution was confirmed by observation of hyolaryngeal movement. | Behavioural | Non-biofeedback Group |
Primary outcome
Maximum Tongue Strength
Time frame: Baseline and within 1 week after completion of the 4-week intervention
Maximum anterior and posterior tongue pressure (kPa) measured with the Iowa Oral Performance Instrument (IOPI). Participants pressed the bulb against the hard palate as forcefully as possible for 3 seconds; three trials were performed at each location and the highest value was used. Higher values indicate greater tongue strength.
Tongue Endurance
Time frame: Baseline and within 1 week after completion of the 4-week intervention
Anterior and posterior tongue endurance (seconds) measured with the IOPI as the time participants maintained 50% of their maximum tongue pressure. Three trials were performed at each location and the longest duration was used. Longer duration indicates greater endurance.
5 secondary outcomes
Swallowing pressure
Time frame: Baseline and within 1 week after completion of the 4-week intervention
Suprahyoid Muscle Activity
Time frame: Baseline and within 1 week after completion of the 4-week intervention
Swallowing-Related Quality of Life (T-SWAL-QOL)
Time frame: Baseline and within 1 week after completion of the 4-week intervention
Dysphagia Symptom Severity (T-EAT-10)
Time frame: Baseline and within 1 week after completion of the 4-week intervention
Functional Oral Intake (FOIS)
Time frame: Baseline and within 1 week after completion of the 4-week 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 30 Oct 2026.
- 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 Effortful swallow exercise with visual biofeedback and Effortful swallow exercise without visual biofeedback in people with PARKINSON DISEASE (Disorder) and Dysphagia, run by Saglik Bilimleri Universitesi 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 30 Oct 2026. 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?
Maximum Tongue Strength (time frame: Baseline and within 1 week after completion of the 4-week intervention). The study lists 2 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 30 Oct 2026.