StrokeNCT07922811
Submaximal Versus Maximal Isometric Tongue Training After Stroke
A study testing Isometric tongue resistance training at 80% 1RM and Isometric tongue resistance training at 100% 1RM in people with Stroke and Deglutition Disorder, run by Necmettin Erbakan University at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Deglutition Disorder
- What is being tested?
- Isometric tongue resistance training at 80% 1RM and Isometric tongue resistance training at 100% 1RM
- 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
- 38 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 3 Jan 2024to 1 Apr 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
- Diagnosis of ischaemic or haemorrhagic stroke according to ICD-10
- 1 to 12 months since stroke onset
- Mini-Mental State Examination score of 21 or higher
- Score of 94 or lower on the Turkish version of the Modified Mann Assessment of Swallowing Ability (TR-MMASA)
- Posterior maximum isometric tongue pressure below 40 kPa
Who cannot join
- History of head and neck cancer or radiotherapy to the head and neck
- Diagnosed neurodegenerative disease
- Diagnosed cognitive or psychiatric disorder
- History of cardiomyopathy, congestive heart failure or myocardial infarction
- History of pulmonary embolism or deep vein thrombosis
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kayseri City Education and Research Hospital
Kayseri, 38080
Selçuk University Faculty of Medicine Hospital
Konya, 42130
About this study
Official title: Effects of Submaximal Versus Maximal Isometric Lingual Resistance Training on Tongue Strength and Swallowing Function After Stroke: A Pilot Randomised Controlled Trial
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:
- Does training at 80% or 100% of a person's maximum tongue pressure increase tongue strength more than usual care?
- Does training at 100% of maximum tongue pressure increase tongue strength more than training at 80%?
- Does either training intensity improve swallowing safety, throat residue after swallowing, the ability to eat by mouth, or swallowing-related quality of life?
Read more
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.
Read the detailed description
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.
- Conditions
- Stroke, Deglutition Disorder
- Being tested
- Isometric tongue resistance training at 80% 1RM, Isometric tongue resistance training at 100% 1RM
- Keywords
- Tongue Strength, Isometric Exercise, Resistance Training, Iowa Oral Performance Instrument
- 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.
Isometric tongue resistance training at 80% 1RMBehavioural
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.
Isometric tongue resistance training at 100% 1RMBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 80% 1RM Isometric Tongue Training | Experimental | 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. Receives: Behavioral: Isometric tongue resistance training at 80% 1RM |
| 100% 1RM Isometric Tongue Training | Experimental | 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. Receives: Behavioral: Isometric tongue resistance training at 100% 1RM |
| Usual Care | No intervention | Routine clinical follow-up without structured tongue exercise during the six-week study period. The training protocol was offered to participants after data collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start3 Jan 2024
- Primary completion1 Mar 2025
- Study completion1 Apr 2025
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 Necmettin Erbakan 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
- Model description
- Three-arm parallel-group pilot randomised controlled trial: isometric tongue resistance training at 80% of the one-repetition maximum (1RM), training at 100% 1RM, and usual care. Randomisation was stratified by age (41-60 and \>60 years).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Anadolu University
- Responsible party
- Principal investigator, Süleyman Kocaoğlu, Necmettin Erbakan University
- Investigators
- Süleyman Kocaoğlu, Principal investigator, Necmettin Erbakan UniversityNurdan cankuvvet, Study director, Anadolu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922811
- Sponsor's protocol ID
- AU-597385
- Other IDs
- 324S276, 597385
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Submaximal Versus Maximal Isometric Lingual Resistance Training on Tongue Strength and Swallowing Function After Stroke: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07922811
- Acronym / sponsor ID
- AU-597385
- Conditions
- Stroke, Deglutition Disorder
- Keywords
- Tongue Strength, Isometric Exercise, Resistance Training, Iowa Oral Performance Instrument
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Anadolu University
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 6 Nov 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 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:
- Does training at 80% or 100% of a person's maximum tongue pressure increase tongue strength more than usual care?
- Does training at 100% of maximum tongue pressure increase tongue strength more than training at 80%?
- Does either training intensity improve swallowing safety, throat residue after swallowing, the ability to eat by mouth, or swallowing-related quality of life?
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm parallel-group pilot randomised controlled trial: isometric tongue resistance training at 80% of the one-repetition maximum (1RM), training at 100% 1RM, and usual care. Randomisation was stratified by age (41-60 and >60 years).
| Arm | Type | Receives |
|---|---|---|
| 80% 1RM Isometric Tongue Training | Experimental | Behavioral: Isometric tongue resistance training at 80% 1RMIsometric 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. |
| 100% 1RM Isometric Tongue Training | Experimental | Behavioral: Isometric tongue resistance training at 100% 1RMIsometric 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. |
| Usual Care | No intervention | –Routine clinical follow-up without structured tongue exercise during the six-week study period. The training protocol was offered to participants after data collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Diagnosis of ischaemic or haemorrhagic stroke according to ICD-10
- 1 to 12 months since stroke onset
- Mini-Mental State Examination score of 21 or higher
- Score of 94 or lower on the Turkish version of the Modified Mann Assessment of Swallowing Ability (TR-MMASA)
Key exclusion criteria (5 listed)
- History of head and neck cancer or radiotherapy to the head and neck
- Diagnosed neurodegenerative disease
- Diagnosed cognitive or psychiatric disorder
- History of cardiomyopathy, congestive heart failure or myocardial infarction
- History of pulmonary embolism or deep vein thrombosis
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 |
|---|---|---|
| Isometric tongue resistance training at 80% 1RMIowa 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. | Behavioural | 80% 1RM Isometric Tongue Training |
| Isometric tongue resistance training at 100% 1RMIowa 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. | Behavioural | 100% 1RM Isometric Tongue Training |
Primary outcome
Posterior maximum isometric tongue pressure
Time frame: Baseline and 6 weeks
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.
9 secondary outcomes
Anterior maximum isometric tongue pressure
Time frame: Baseline and 6 weeks
Anterior tongue endurance
Time frame: Baseline and 6 weeks
Posterior tongue endurance
Time frame: Baseline and 6 weeks
Penetration-Aspiration Scale score, puree
Time frame: Baseline and 6 weeks
Penetration-Aspiration Scale score, thin liquid
Time frame: Baseline and 6 weeks
Vallecular residue (Yale Pharyngeal Residue Severity Rating Scale)
Time frame: Baseline and 6 weeks
Pyriform sinus residue (Yale Pharyngeal Residue Severity Rating Scale)
Time frame: Baseline and 6 weeks
Functional Oral Intake Scale
Time frame: Baseline and 6 weeks
Swallowing-related quality of life (T-SWAL-QOL)
Time frame: Baseline and 6 weeks
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 6 Nov 2026.
- Individual participant dataSharing planned: 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.
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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.
Süleyman Kocaoğlu principal investigator
Necmettin Erbakan University
Nurdan cankuvvet study director
Anadolu University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric tongue resistance training at 80% 1RM and Isometric tongue resistance training at 100% 1RM in people with Stroke and Deglutition Disorder, run by Necmettin Erbakan University at 2 sites 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 6 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Posterior maximum isometric tongue pressure (time frame: Baseline and 6 weeks). 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 6 Nov 2026.