An interventional study of Effortful swallow exercise with visual biofeedback and Effortful swallow exercise without visual biofeedback in PARKINSON DISEASE (Disorder) and Dysphagia, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Treatment
Among 171 studies in Parkinson Disease with a site in Turkey — 49 open to participants now, 56 under way, none of them phase 3. Parkinson Disease · Turkey.
Among the 171 studies in Parkinson Disease with a site in Turkey, this one is the 44th largest by enrollment of the 98 interventional ones, is one of 22 that started in 2024, is one of 91 with no phase, and was the 171st registered.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 35 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →49 of the 171 studies in Parkinson Disease with a site in Turkey are open now, in 12 countries. Each count lists the studies.
Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →171 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 22 started in 2024.
Median enrollment 32 across the 98 interventional studies, 61 across the 73 observational. Of the 103 that completed or were terminated, 2 (2%) have results posted.
9 of 171 have an industry lead sponsor. The 10 most frequent:
Saglik Bilimleri Universitesi is the lead sponsor of 453 studies on the registry; 140 are open to participants now.
Saglik Bilimleri Universitesi has 5 studies filed under Parkinson Disease — fewer than ten, so there is no comparison to draw.
20 of the studies in Parkinson Disease with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07815964Acibadem UniversityTurkish Validity and Reliability of the Parkinson's Disease Neuropsychometric Dementia Assessment Questionnaire in Individuals With Parkinson's Disease | 2026-11-01 |
| NCT07817862Istanbul UniversityEffectiveness of a Home-Based Exercise Program Supported by Self-Management Education in People With Parkinson Disease | 2026-11-05 |
| NCT07302386Marmara UniversityExercise Management in Parkinson's Disease | 2026-11-07 |
| NCT07678983Izmir Bakircay UniversityWhole-Body Vibration in Parkinson Disease | 2026-12 |
| NCT06154356Karamanoğlu Mehmetbey UniversityAction Observation and Motor Imagery Therapy in Parkinson's Disease | 2026-12 |
Among the 171 studies in Parkinson Disease with a site in Turkey, from their registry updates:
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:
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Effortful swallow exercise with visual biofeedback
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.
Behavioral: Effortful swallow exercise without visual biofeedback
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.
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.
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.
Time frame: 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.
Time frame: Baseline and within 1 week after completion of the 4-week intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and within 1 week after completion of the 4-week intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2024 to primary completion in Jun 2025, 9 months.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 9 months is below that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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