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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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-

Other trials in Turkey (Türkiye)

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 groups in NCT07261462
Study groupRoleWhat they receive
Exercise ProgramExperimentalAll 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.

  1. 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)
  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.

  1. First posted3 Dec 2025
  2. Study start1 Feb 2022
  3. Primary completion1 Dec 2022
  4. Study completion25 Dec 2022

Resources

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)
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.

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.

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