StrokeNCT07261462
Oropharyngeal and Trunk Muscle Interactions After Stroke
A study testing Exercise in people with Stroke, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Background:This study aimed to investigate the effects of a short-term tongue-jaw-back isometric exercise program on these muscle groups and their interrelationships in the post-stroke period. Methods: Twelve post-stroke patients were included in the study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 25 Dec 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being within the first 30 days of stroke onset
- being between 18 and 80 years of age
- having experienced their first stroke
- undergoing inpatient physical therapy and rehabilitation
- voluntarily consenting to participate
Who cannot join
- cognitive impairment
- severe aphasia or communication difficulties
- a history of other neurological diseases
- a history of surgery in the oral or jaw region
- refusal to participate.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nezahat Keleşoğlu Faculty of Health Sciences
Meram, Konya, (541) 847-
About this study
Official title: The Effects of a Short-Term Isometric Exercise Program Targeting Tongue, Jaw, and Trunk Muscles on Muscle Strength and Synergistic Relationships in Post-Stroke Patients: A Single-Group Pre-Post Study
Background:This study aimed to investigate the effects of a short-term tongue-jaw-back isometric exercise program on these muscle groups and their interrelationships in the post-stroke period.
Methods: Twelve post-stroke patients were included in the study. A 14-day exercise program, consisting of two daily sessions targeting the tongue, jaw, and back muscles, was administered. Anterior and posterior tongue muscles, jaw muscles, and back muscle strength were assessed before and after the exercise program. Tongue pressure was measured using the Iowa Oral Performance Instrument (IOPI), chewing strength with a hand-held dynamometer, and back strength with a stabilizing pressure biofeedback unit.
Read more
Results: After the 14-day isometric exercise program, anterior tongue strength (p = 0.025), posterior tongue strength (p = 0.021), and back muscle strength (p = 0.005) showed significant increases compared to pre-treatment values. No significant change was observed in jaw strength (p = 0.475). Spearman correlation analysis revealed no significant relationships between tongue muscles and jaw or back muscles before treatment, and simple correlations after treatment also did not reach significance. However, partial correlation analysis showed that the relationship between tongue muscles was significantly influenced by jaw strength (p = 0.040) and back strength (p = 0.038) after the intervention.
Conclusions: Short-term isometric exercises targeting tongue, jaw, and back muscles in post-stroke patients effectively increased tongue and back muscle strength and enhanced the synergistic relationship among these muscle groups.
Read the detailed description
Methods This study was designed as a single-group pre-post trial. A total of 12 post-stroke patients were included. All participants underwent a 14-day isometric exercise program targeting the tongue, jaw, and trunk muscles, with two daily sessions.
Study Design and Ethical Approval This study was designed as a prospective, single-center research project conducted at the Department of Physical Medicine and Rehabilitation, Meram Faculty of Medicine, Necmettin Erbakan University. Ethical approval for the study was obtained from the Necmettin Erbakan University Health Sciences Scientific Research Ethics Committee with decision number 2021/13-71. All participants included in the study provided informed voluntary consent. The study was conducted in a single-blind manner, with the researcher who performed the patient assessments being different from the specialist who administered the exercise intervention.
Participants Twelve patients with a diagnosis of acute ischemic or hemorrhagic stroke, who were hospitalized in the Physical Medicine and Rehabilitation service between February 2022 and December 2022, were enrolled in the study. Inclusion criteria were: being within the first 30 days of stroke onset; being between 18 and 80 years of age; having experienced their first stroke; undergoing inpatient physical therapy and rehabilitation; and voluntarily consenting to participate. Exclusion criteria were: cognitive impairment, severe aphasia or communication difficulties, a history of other neurological diseases, a history of surgery in the oral or jaw region, and refusal to participate.
Outcome Measures
The participants' sociodemographic data (age and stroke duration) were recorded. The following clinical and functional assessments were performed both before and after the 14-day program:
Motor Functional Status: Brunnstromm stages were used to evaluate motor recovery levels (upper extremity, hand, and lower extremity) of the hemiplegic side.
Functional Independence Status: The Barthel Index was used to determine the participants' level of independence in daily living activities.
Dysphagia Assessment: The Eating Assessment Tool-10 (EAT-10) score was used to determine the severity of swallowing difficulty.
Tongue Pressure Measurement: The Iowa Oral Performance Instrument (IOPI) was used to assess tongue muscle strength. For Anterior Tongue Pressure (ATP), the IOPI bulb was placed longitudinally along the hard palate, behind the alveolar ridge. For Posterior Tongue Pressure (PTP), the bulb was positioned at the posterior border of the hard palate. Both measurements were repeated three times, and the mean values were recorded.
Chewing Muscle Strength Measurement: Chewing muscle strength, representing masticatory force, was measured using a hand-held dynamometer. Participants were instructed to perform a jaw-opening movement against the dynamometer placed under the chin. This measurement was repeated three times, and the average value was used for analysis.
Back Muscle Strength Measurement: Back muscle strength was measured with a stabilizing pressure biofeedback unit. Individuals were asked to lie supine on a treatment table with their head turned to one side and knees flexed. These measurements were repeated three times, and the mean value was recorded.
Exercise Program
All participants received isometric strengthening exercises twice daily for 14 days, with each session lasting approximately 30-40 minutes. Each exercise was performed for 15 repetitions, with each repetition held for 5 seconds followed by a rest. The exercise program included the following:
Isometric Exercises for Tongue Muscles: Using a tongue depressor, patients were instructed to press their tongue forward, upward, downward, and to the sides against the depressor. These exercises aim to increase the strength of the tongue muscles, which play a critical role in swallowing function.
Isometric Exercises for Jaw Muscles: Patients were asked to perform a chin tuck while in a supine position by tucking their chin toward their chest. Additionally, they were asked to place a soft ball under their chin and press against it to create an isometric contraction. These exercises target the muscles that facilitate swallowing.
Isometric Exercises for Back Muscles: Patients who could not sit with proper balance performed the exercises in a supine position with a soft ball placed under their back. They were asked to press their back against the ball to perform an isometric contraction. Patients with sufficient sitting balance were instructed to sit upright, pressing their backs against a chair to engage their trunk muscles. Strengthening the trunk muscles in this manner supports overall postural control and swallowing stability.
- Conditions
- Stroke
- Being tested
- Exercise
- Keywords
- Back muscles, Post-stroke, Tongue strength, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Isometric Exercises for Tongue Muscles: Using a tongue depressor, patients were instructed to press their tongue forward, upward, downward, and to the sides against the depressor. These exercises aim to increase the strength of the tongue muscles, which play a critical role in swallowing function .
Isometric Exercises for Jaw Muscles: Patients were asked to perform a chin tuck while in a supine position by tucking their chin toward their chest. Additionally, they were asked to place a soft ball under their chin and press against it to create an isometric contraction. These exercises target the muscles that facilitate swallowing.
Isometric Exercises for Back Muscles: Patients who could not sit with proper balance performed the exercises in a supine position with a soft ball placed under their back. They were asked to press their back against the ball to perform an isometric contraction. Patients with sufficient sitting balance were instructed to sit upright, pressing their backs
| Study group | Role | What they receive |
|---|---|---|
| Exercise Program | Experimental | All participants received isometric strengthening exercises twice daily for 14 days, with each session lasting approximately 30-40 minutes. Each exercise was performed for 15 repetitions, with each repetition held for 5 seconds followed by a rest. The exercise program included the following:
Isometric Exercises for Tongue Muscles: Using a tongue depressor, patients were instructed to press their tongue forward, upward, downward, and to the sides against the depressor. These exercises aim to increase the strength of the tongue muscles, which play a critical role in swallowing function.
Isometric Exercises for Jaw Muscles: Patients were asked to perform a chin tuck while in a supine position by tucking their chin toward their chest. Additionally, they were asked to place a soft ball under their chin and press against it to create an isometric contraction. These exercises target the muscles that facilitate swallowing.
Isometric Exercises for Back Muscles: Patients who could not Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Functional Status
Brunnstromm stages were used to evaluate motor recovery levels (upper extremity, hand, and lower extremity) of the hemiplegic side
Measured: The following clinical and functional assessments were performed both before and after the 14-day program
Secondary outcomes (1)
Functional Independence Status
The Barthel Index was used to determine the participants' level of independence in daily living activities
Measured: The following clinical and functional assessments were performed both before and after the 14-day program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Feb 2022
- Primary completion1 Dec 2022
- Study completion25 Dec 2022
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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants included in the study provided informed voluntary consent. The study was conducted in a single-blind manner, with the researcher who performed the patient assessments being different from the specialist who administered the exercise intervention. Inclusion criteria were: being within the first 30 days of stroke onset; being between 18 and 80 years of age; having experienced their first stroke; undergoing inpatient physical therapy and rehabilitation; and voluntarily consenting to participate. Exclusion criteria were: cognitive impairment, severe aphasia or communication difficulties, a history of other neurological diseases, a history of surgery in the oral or jaw region, and refusal to participate.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Altuntas Yilmaz, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261462
- Sponsor's protocol ID
- NEUPT202502
- Other IDs
- Necmettin Erbakan University
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ndividual participant data (IPD) will not be shared because of ethical and privacy restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Short-Term Isometric Exercise Program Targeting Tongue, Jaw, and Trunk Muscles on Muscle Strength and Synergistic Relationships in Post-Stroke Patients: A Single-Group Pre-Post Study
- ClinicalTrials.gov ID
- NCT07261462
- Acronym / sponsor ID
- NEUPT202502
- Conditions
- Stroke
- Keywords
- Back muscles, Post-stroke, Tongue strength, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 25 Dec 2022 (actual)
- First posted
- 3 Dec 2025 (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.
Background:This study aimed to investigate the effects of a short-term tongue-jaw-back isometric exercise program on these muscle groups and their interrelationships in the post-stroke period.
Methods: Twelve post-stroke patients were included in the study. A 14-day exercise program, consisting of two daily sessions targeting the tongue, jaw, and back muscles, was administered. Anterior and posterior tongue muscles, jaw muscles, and back muscle strength were assessed before and after the exercise program. Tongue pressure was measured using the Iowa Oral Performance Instrument (IOPI), chewing strength with a hand-held dynamometer, and back strength with a stabilizing pressure biofeedback unit.
Results: After the 14-day isometric exercise program, anterior tongue strength (p = 0.025), posterior tongue strength (p = 0.021), and back muscle strength (p = 0.005) showed significant increases compared to pre-treatment values. No significant change was observed in jaw strength (p = 0.475). Spearman correlation analysis revealed no significant relationships between tongue muscles and jaw or back muscles before treatment, and simple correlations after treatment also did not reach significance. However, partial correlation analysis showed that the relationship between tongue muscles was significantly influenced by jaw strength (p = 0.040) and back strength (p = 0.038) after the intervention.
Conclusions: Short-term isometric exercises targeting tongue, jaw, and back muscles in post-stroke patients effectively increased tongue and back muscle strength and enhanced the synergistic relationship among these muscle groups.
Detailed description
Methods This study was designed as a single-group pre-post trial. A total of 12 post-stroke patients were included. All participants underwent a 14-day isometric exercise program targeting the tongue, jaw, and trunk muscles, with two daily sessions.
Study Design and Ethical Approval This study was designed as a prospective, single-center research project conducted at the Department of Physical Medicine and Rehabilitation, Meram Faculty of Medicine, Necmettin Erbakan University. Ethical approval for the study was obtained from the Necmettin Erbakan University Health Sciences Scientific Research Ethics Committee with decision number 2021/13-71. All participants included in the study provided informed voluntary consent. The study was conducted in a single-blind manner, with the researcher who performed the patient assessments being different from the specialist who administered the exercise intervention.
Participants Twelve patients with a diagnosis of acute ischemic or hemorrhagic stroke, who were hospitalized in the Physical Medicine and Rehabilitation service between February 2022 and December 2022, were enrolled in the study. Inclusion criteria were: being within the first 30 days of stroke onset; being between 18 and 80 years of age; having experienced their first stroke; undergoing inpatient physical therapy and rehabilitation; and voluntarily consenting to participate. Exclusion criteria were: cognitive impairment, severe aphasia or communication difficulties, a history of other neurological diseases, a history of surgery in the oral or jaw region, and refusal to participate.
Outcome Measures
The participants' sociodemographic data (age and stroke duration) were recorded. The following clinical and functional assessments were performed both before and after the 14-day program:
Motor Functional Status: Brunnstromm stages were used to evaluate motor recovery levels (upper extremity, hand, and lower extremity) of the hemiplegic side.
Functional Independence Status: The Barthel Index was used to determine the participants' level of independence in daily living activities.
Dysphagia Assessment: The Eating Assessment Tool-10 (EAT-10) score was used to determine the severity of swallowing difficulty.
Tongue Pressure Measurement: The Iowa Oral Performance Instrument (IOPI) was used to assess tongue muscle strength. For Anterior Tongue Pressure (ATP), the IOPI bulb was placed longitudinally along the hard palate, behind the alveolar ridge. For Posterior Tongue Pressure (PTP), the bulb was positioned at the posterior border of the hard palate. Both measurements were repeated three times, and the mean values were recorded.
Chewing Muscle Strength Measurement: Chewing muscle strength, representing masticatory force, was measured using a hand-held dynamometer. Participants were instructed to perform a jaw-opening movement against the dynamometer placed under the chin. This measurement was repeated three times, and the average value was used for analysis.
Back Muscle Strength Measurement: Back muscle strength was measured with a stabilizing pressure biofeedback unit. Individuals were asked to lie supine on a treatment table with their head turned to one side and knees flexed. These measurements were repeated three times, and the mean value was recorded.
Exercise Program
All participants received isometric strengthening exercises twice daily for 14 days, with each session lasting approximately 30-40 minutes. Each exercise was performed for 15 repetitions, with each repetition held for 5 seconds followed by a rest. The exercise program included the following:
Isometric Exercises for Tongue Muscles: Using a tongue depressor, patients were instructed to press their tongue forward, upward, downward, and to the sides against the depressor. These exercises aim to increase the strength of the tongue muscles, which play a critical role in swallowing function.
Isometric Exercises for Jaw Muscles: Patients were asked to perform a chin tuck while in a supine position by tucking their chin toward their chest. Additionally, they were asked to place a soft ball under their chin and press against it to create an isometric contraction. These exercises target the muscles that facilitate swallowing.
Isometric Exercises for Back Muscles: Patients who could not sit with proper balance performed the exercises in a supine position with a soft ball placed under their back. They were asked to press their back against the ball to perform an isometric contraction. Patients with sufficient sitting balance were instructed to sit upright, pressing their backs against a chair to engage their trunk muscles. Strengthening the trunk muscles in this manner supports overall postural control and swallowing stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants included in the study provided informed voluntary consent. The study was conducted in a single-blind manner, with the researcher who performed the patient assessments being different from the specialist who administered the exercise intervention. Inclusion criteria were: being within the first 30 days of stroke onset; being between 18 and 80 years of age; having experienced their first stroke; undergoing inpatient physical therapy and rehabilitation; and voluntarily consenting to participate. Exclusion criteria were: cognitive impairment, severe aphasia or communication difficulties, a history of other neurological diseases, a history of surgery in the oral or jaw region, and refusal to participate.
| Arm | Type | Receives |
|---|---|---|
| Exercise Program | Experimental | Other: ExerciseAll participants received isometric strengthening exercises twice daily for 14 days, with each session lasting approximately 30-40 minutes. Each exercise was performed for 15 repetitions, with each repetition held for 5 seconds followed by a rest. The exercise program included the following: Isometric Exercises for Tongue Muscles: Using a tongue depressor, patients were instructed to press their tongue forward, upward, downward, and to the sides against the depressor. These exercises aim to increase the strength of the tongue muscles, which play a critical role in swallowing function. Isometric Exercises for Jaw Muscles: Patients were asked to perform a chin tuck while in a supine position by tucking their chin toward their chest. Additionally, they were asked to place a soft ball under their chin and press against it to create an isometric contraction. These exercises target the muscles that facilitate swallowing. Isometric Exercises for Back Muscles: Patients who could not |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- being within the first 30 days of stroke onset
- being between 18 and 80 years of age
- having experienced their first stroke
- undergoing inpatient physical therapy and rehabilitation
- voluntarily consenting to participate
Key exclusion criteria (5 listed)
- cognitive impairment
- severe aphasia or communication difficulties
- a history of other neurological diseases
- a history of surgery in the oral or jaw region
- refusal to participate.
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 |
|---|---|---|
| ExerciseIsometric Exercises for Tongue Muscles: Using a tongue depressor, patients were instructed to press their tongue forward, upward, downward, and to the sides against the depressor. These exercises aim to increase the strength of the tongue muscles, which play a critical role in swallowing function . Isometric Exercises for Jaw Muscles: Patients were asked to perform a chin tuck while in a supine position by tucking their chin toward their chest. Additionally, they were asked to place a soft ball under their chin and press against it to create an isometric contraction. These exercises target the muscles that facilitate swallowing. Isometric Exercises for Back Muscles: Patients who could not sit with proper balance performed the exercises in a supine position with a soft ball placed under their back. They were asked to press their back against the ball to perform an isometric contraction. Patients with sufficient sitting balance were instructed to sit upright, pressing their backs | Other | Exercise Program |
Primary outcome
Motor Functional Status
Time frame: The following clinical and functional assessments were performed both before and after the 14-day program
Brunnstromm stages were used to evaluate motor recovery levels (upper extremity, hand, and lower extremity) of the hemiplegic side
1 secondary outcome
Functional Independence Status
Time frame: The following clinical and functional assessments were performed both before and after the 14-day program
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 9 Dec 2025.
- Effects of Tongue-Strengthening Exercise on Tongue Strength Reserve and Detraining Effects among Healthy Adults: A Randomized Controlled TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No. ndividual participant data (IPD) will not be shared because of ethical and privacy restrictions.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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 Exercise in people with Stroke, run by Necmettin Erbakan 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 5 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 9 Dec 2025. 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?
Motor Functional Status (time frame: The following clinical and functional assessments were performed both before and after the 14-day program). 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 9 Dec 2025.