An interventional study of Isometric tongue resistance training at 80% 1RM and Isometric tongue resistance training at 100% 1RM in Stroke and Deglutition Disorder, sponsored by Necmettin Erbakan University. Completed at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Necmettin Erbakan University · Not applicable, Interventional, and Treatment
The goal of this clinical trial was to learn whether the intensity of tongue-strengthening exercise affects tongue strength and swallowing in adults who have swallowing difficulty (dysphagia) 1 to 12 months after a stroke. The main questions it aimed to answer were:
Researchers compared the two exercise groups with a usual-care group that did not receive structured exercise.
Participants in the exercise groups pressed their tongue against an air-filled bulb (Iowa Oral Performance Instrument) three times a week for six weeks, with the target pressure updated every week. All participants had their tongue strength, tongue endurance and swallowing (by endoscopic swallowing examination) assessed before and after the six weeks. Participants in the exercise groups were assessed again four weeks later.
This three-arm pilot randomised controlled trial was conducted at two otorhinolaryngology outpatient clinics in Türkiye as part of a doctoral thesis funded by TÜBİTAK. Participants were randomised, stratified by age (41-60 and >60 years), to isometric lingual resistance training at 80% of the one-repetition maximum (1RM), training at 100% 1RM, or usual care. Training consisted of anterior and posterior tongue presses with the Iowa Oral Performance Instrument (5 sets × 10 repetitions per region, 2-s holds), three sessions per week for six weeks, with 1RM re-measured weekly. Outcome assessors were not informed of group allocation. Assessments were performed at baseline, at six weeks and, in the training groups, four weeks after the intervention.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 38 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Necmettin Erbakan University is the lead sponsor of 201 studies on the registry; 48 are open to participants now.
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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.
Isometric tongue resistance training with the Iowa Oral Performance Instrument at 80% of the one-repetition maximum (1RM), three sessions per week for six weeks. Each session comprised anterior and posterior tongue presses, 5 sets × 10 repetitions per region, 2-s holds, 10-s rest between repetitions and 1-min rest between sets. 1RM was re-measured at the start of each week and the target pressure updated.
Behavioral: Isometric tongue resistance training at 80% 1RM
Isometric tongue resistance training with the Iowa Oral Performance Instrument at 100% of the one-repetition maximum (1RM), with a maximal effort on every repetition, three sessions per week for six weeks. Session structure, rest intervals and weekly 1RM re-measurement were identical to the 80% 1RM arm.
Behavioral: Isometric tongue resistance training at 100% 1RM
Routine clinical follow-up without structured tongue exercise during the six-week study period. The training protocol was offered to participants after data collection.
Iowa Oral Performance Instrument-guided isometric tongue presses against the hard palate at the anterior and posterior tongue, at 80% of the weekly re-measured one-repetition maximum, with visual feedback; 5 sets × 10 repetitions per region, 2-s holds, three sessions per week for six weeks.
Iowa Oral Performance Instrument-guided isometric tongue presses against the hard palate at the anterior and posterior tongue, with a maximal effort (100% of the weekly re-measured one-repetition maximum) on every repetition; 5 sets × 10 repetitions per region, 2-s holds, three sessions per week for six weeks.
Posterior maximum isometric tongue pressure
Highest of three maximal tongue-to-palate presses at the posterior tongue (10 mm anterior to the circumvallate papillae), measured in kilopascals (kPa) with the Iowa Oral Performance Instrument.
Time frame: Baseline and 6 weeks
Anterior maximum isometric tongue pressure
Highest of three maximal tongue-to-palate presses at the anterior tongue (10 mm posterior to the tongue tip), measured in kPa with the Iowa Oral Performance Instrument.
Time frame: Baseline and 6 weeks
Anterior tongue endurance
Longest time (seconds) for which participants sustained 50% of the anterior maximum pressure obtained in the same session, measured with the Iowa Oral Performance Instrument.
Time frame: Baseline and 6 weeks
Posterior tongue endurance
Longest time (seconds) for which participants sustained 50% of the posterior maximum pressure obtained in the same session, measured with the Iowa Oral Performance Instrument.
Time frame: Baseline and 6 weeks
Penetration-Aspiration Scale score, puree
Airway protection during a 10-mL IDDSI Level 3 (puree) bolus on fibreoptic endoscopic evaluation of swallowing; 8-point scale from 1 (no airway entry) to 8 (silent aspiration); lower scores are better.
Time frame: Baseline and 6 weeks
Penetration-Aspiration Scale score, thin liquid
Airway protection during a 10-mL IDDSI Level 0 (thin liquid) bolus on fibreoptic endoscopic evaluation of swallowing; 8-point scale from 1 to 8; lower scores are better.
Time frame: Baseline and 6 weeks
Vallecular residue (Yale Pharyngeal Residue Severity Rating Scale)
Residue in the valleculae after a puree bolus on fibreoptic endoscopic evaluation of swallowing; 5-point scale from 1 (none) to 5 (severe); lower scores are better.
Time frame: Baseline and 6 weeks
Pyriform sinus residue (Yale Pharyngeal Residue Severity Rating Scale)
Residue in the pyriform sinuses after a puree bolus on fibreoptic endoscopic evaluation of swallowing; 5-point scale from 1 (none) to 5 (severe); lower scores are better.
Time frame: Baseline and 6 weeks
Functional Oral Intake Scale
Level of oral intake on a 7-point scale from 1 (nothing by mouth) to 7 (total oral diet without restrictions); higher scores are better.
Time frame: Baseline and 6 weeks
Swallowing-related quality of life (T-SWAL-QOL)
Total score on the Turkish version of the Swallowing Quality of Life Questionnaire; higher scores indicate better swallowing-related quality of life.
Time frame: Baseline and 6 weeks
Tongue pressure at follow-up
Anterior and posterior maximum isometric tongue pressure (kPa), Iowa Oral Performance Instrument; assessed in the two training arms only.
Time frame: 10 weeks (4 weeks after the end of training)
Tongue endurance at follow-up
Anterior and posterior tongue endurance (seconds) at 50% of the same-session maximum, Iowa Oral Performance Instrument; assessed in the two training arms only.
Time frame: 10 weeks (4 weeks after the end of training)
Plan to share: Yes — De-identified individual participant data underlying the results reported in the article (tongue pressure, tongue endurance, PAS, YPRSS, FOIS and T-SWAL-QOL at all time points, together with age stratum, sex and stroke characteristics) will be shared.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning at publication of the main article and for at least 5 years thereafter.
Access criteria: Data will be available to researchers who provide a methodologically sound proposal, upon reasonable request to the corresponding author (fzt.s.kocaoglu@gmail.com). A data-sharing agreement may be required.
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Mar 2025, 13 months.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 13 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
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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