DysphagiaNCT06278025
Dysphagia and Deep Cervical Flexor Muscles
An observational study of Dysphagia and Neurological Disorder, run by Atılım University at 1 site in Turkey (Türkiye).
Trial summary
Cervical posture is vital for normal swallowing function. Changes in cervical posture during swallowing alter the bolus flow and swallowing kinematics through changes in gravity and oropharyngeal space. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dysphagia, Neurological Disorder
- What is being tested?
- assessment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 1 Feb 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: participants aged between 18 - 65 and diagnoses neurological disease will included in the study.
Who may be able to join
- diagnosis of neurological disease, age range inclusive of 18-65 years , independent sit-to-stand, prior consultation for dysphagia, and underwent a Modified Barium Swallowing Study (MBSS).
Who cannot join
- neck pain complaints in the previous 30 days history of cervical surgery and head and neck cancer, cervical pathology involving the neck region such as cervical disc herniation or radiculopathy presence of cervical osteophytes and/or cervical kyphosis detected in the MBSS, history of rheumatic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Deep Cervical Flexor Muscle Strength and Endurance in Patients With and Without Neurogenic Dysphagia
Cervical posture is vital for normal swallowing function. Changes in cervical posture during swallowing alter the bolus flow and swallowing kinematics through changes in gravity and oropharyngeal space. The hyoid bone does not articulate with any bone, so it requires adequate tension of the hyolaryngeal complex and proper cervical postural alignment to maintain its stabilization and position. Changes in cervical posture and stabilization can cause changes in hyoid bone position and kinematics through muscles and ligaments which may lead to decrease in hyoid elevation, loss of optimal strength of the suprahyoid and infrahyoid muscles due to disrupted length-tension relationship, and an increased risk of aspiration due to insufficient laryngeal elevation. Further, deterioration in cervical posture and decreased stabilization resulting from cervical muscle weakness or/both endurance could affect the control and strength of masticatory muscles, tongue muscles and suprahyoid - infrahyoid muscles, which are involved in swallowing function. Whereby DCF weakness gives rise to inadequate cervical stabilization, change in hyoid bone stabilization, alterations in suprahyoid and infrahyoid muscle function, and decreased laryngeal elevation may adversely affect the normal function of the swallowing related muscles. Thus, decreased cervical stabilization, which is often seen in neurological diseases, may be related to neurogenic dysphagia. Given the known changes in cervical stabilization as a consequence of neurologic injury, the additional impact on swallowing or a potentially already neurologically-disordered swallow is considered. Thus, loss of cervical stabilization may be one of the factors affecting dysphagia in patients with neurological diseases providing more information on all potential factors contributing to swallow impairment, potentially leading to more targeted and effective swallowing interventions. However, there is no study investigating the role of the DCF muscles in dysphagia. Therefore, the aim of the present study was to comparison of deep cervical flexor muscle strength and endurance in patients with and without neurogenic dysphagia.
- Conditions
- Dysphagia, Neurological Disorder
- Being tested
- assessment
- Medical subject headings
- Deglutition Disorders, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentDiagnostic test
DCF Muscle Strength Evaluation Evaluation of the DCF Endurance Functional Independence Assessment
| Study group | Role | What they receive |
|---|---|---|
| patients with dysphagia (study) | In the modified barium swallowing study, liquid in the amount of 5 ml was used because it is the optimal amount to monitor physiological events during swallowing . The Penetration Aspiration Scale (PAS) was used to determine the dysphagia severity. The PAS is an 8-point scale describing the degree and nature of laryngeal penetration and aspiration, where a score of 1 refer to 'No penetration or aspiration- No entry of material into the airway', and 8 refer to 'Airway aspiration- Material enters the trachea with no attempt to clear'. According to the MBSS, patients who received a PAS score of 1 were included in the group without dysphagia (control group), and those received a PAS score between 2 and 8 were included in the group with dysphagia (study group). Receives: Diagnostic Test: assessment | |
| patients without dysphagia (control) | In the modified barium swallowing study, liquid in the amount of 5 ml was used because it is the optimal amount to monitor physiological events during swallowing . The Penetration Aspiration Scale (PAS) was used to determine the dysphagia severity. The PAS is an 8-point scale describing the degree and nature of laryngeal penetration and aspiration, where a score of 1 refer to 'No penetration or aspiration- No entry of material into the airway', and 8 refer to 'Airway aspiration- Material enters the trachea with no attempt to clear'. According to the MBSS, patients who received a PAS score of 1 were included in the group without dysphagia (control group), and those received a PAS score between 2 and 8 were included in the group with dysphagia (study group). Receives: Diagnostic Test: assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
dcf muscle strenght
Measured: 1 day
dcf endurance
Measured: 1 day
Functional Independence
Functional Independence Measure
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Sep 2019
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sena N begen, Study chair, Atilim University, Faculty of Health Sciences Department of Physiotherapy and Rehabilitationselen serel arslan, Study director, Hacettepe University Faculty of Physical Therapy and Rehabilitation Ankara, TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278025
- Sponsor's protocol ID
- GO 19/833
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Deep Cervical Flexor Muscle Strength and Endurance in Patients With and Without Neurogenic Dysphagia
- ClinicalTrials.gov ID
- NCT06278025
- Acronym / sponsor ID
- GO 19/833
- Conditions
- Dysphagia, Neurological Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 26 Feb 2024 (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.
Cervical posture is vital for normal swallowing function. Changes in cervical posture during swallowing alter the bolus flow and swallowing kinematics through changes in gravity and oropharyngeal space. The hyoid bone does not articulate with any bone, so it requires adequate tension of the hyolaryngeal complex and proper cervical postural alignment to maintain its stabilization and position. Changes in cervical posture and stabilization can cause changes in hyoid bone position and kinematics through muscles and ligaments which may lead to decrease in hyoid elevation, loss of optimal strength of the suprahyoid and infrahyoid muscles due to disrupted length-tension relationship, and an increased risk of aspiration due to insufficient laryngeal elevation. Further, deterioration in cervical posture and decreased stabilization resulting from cervical muscle weakness or/both endurance could affect the control and strength of masticatory muscles, tongue muscles and suprahyoid - infrahyoid muscles, which are involved in swallowing function. Whereby DCF weakness gives rise to inadequate cervical stabilization, change in hyoid bone stabilization, alterations in suprahyoid and infrahyoid muscle function, and decreased laryngeal elevation may adversely affect the normal function of the swallowing related muscles. Thus, decreased cervical stabilization, which is often seen in neurological diseases, may be related to neurogenic dysphagia. Given the known changes in cervical stabilization as a consequence of neurologic injury, the additional impact on swallowing or a potentially already neurologically-disordered swallow is considered. Thus, loss of cervical stabilization may be one of the factors affecting dysphagia in patients with neurological diseases providing more information on all potential factors contributing to swallow impairment, potentially leading to more targeted and effective swallowing interventions. However, there is no study investigating the role of the DCF muscles in dysphagia. Therefore, the aim of the present study was to comparison of deep cervical flexor muscle strength and endurance in patients with and without neurogenic dysphagia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with dysphagia (study) | – | Diagnostic Test: assessmentIn the modified barium swallowing study, liquid in the amount of 5 ml was used because it is the optimal amount to monitor physiological events during swallowing . The Penetration Aspiration Scale (PAS) was used to determine the dysphagia severity. The PAS is an 8-point scale describing the degree and nature of laryngeal penetration and aspiration, where a score of 1 refer to 'No penetration or aspiration- No entry of material into the airway', and 8 refer to 'Airway aspiration- Material enters the trachea with no attempt to clear'. According to the MBSS, patients who received a PAS score of 1 were included in the group without dysphagia (control group), and those received a PAS score between 2 and 8 were included in the group with dysphagia (study group). |
| patients without dysphagia (control) | – | Diagnostic Test: assessmentIn the modified barium swallowing study, liquid in the amount of 5 ml was used because it is the optimal amount to monitor physiological events during swallowing . The Penetration Aspiration Scale (PAS) was used to determine the dysphagia severity. The PAS is an 8-point scale describing the degree and nature of laryngeal penetration and aspiration, where a score of 1 refer to 'No penetration or aspiration- No entry of material into the airway', and 8 refer to 'Airway aspiration- Material enters the trachea with no attempt to clear'. According to the MBSS, patients who received a PAS score of 1 were included in the group without dysphagia (control group), and those received a PAS score between 2 and 8 were included in the group with dysphagia (study group). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- participants aged between 18 - 65 and diagnoses neurological disease will included in the study.
Key inclusion criteria (1 listed)
- diagnosis of neurological disease, age range inclusive of 18-65 years , independent sit-to-stand, prior consultation for dysphagia, and underwent a Modified Barium Swallowing Study (MBSS).
Key exclusion criteria (1 listed)
- neck pain complaints in the previous 30 days history of cervical surgery and head and neck cancer, cervical pathology involving the neck region such as cervical disc herniation or radiculopathy presence of cervical osteophytes and/or cervical kyphosis detected in the MBSS, history of rheumatic diseases.
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 |
|---|---|---|
| assessmentDCF Muscle Strength Evaluation Evaluation of the DCF Endurance Functional Independence Assessment | Diagnostic test | patients with dysphagia (study), patients without dysphagia (control) |
Primary outcome
dcf muscle strenght
Time frame: 1 day
dcf endurance
Time frame: 1 day
Functional Independence
Time frame: 1 day
Functional Independence Measure
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 22 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
sena N begen study chair
Atilim University, Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
selen serel arslan study director
Hacettepe University Faculty of Physical Therapy and Rehabilitation Ankara, TURKEY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia and Neurological Disorder, run by Atılım 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 1 inclusion and 1 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 22 Sep 2026. 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?
dcf muscle strenght (time frame: 1 day). The study lists 3 primary outcomes in all. 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 22 Sep 2026.