DysphagiaNCT05782803
Investigation of the Effect of Craniocervical Flexion Training on Suprahyoid Muscles in Healthy Individuals
A study testing Exercises Group in people with Dysphagia and Rehabilitation, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
Swallowing; It is a complex, dynamic, sensorimotor process involving more than 30 muscles located bilaterally in the oral, pharyngeal, and esophageal regions and involving the safe delivery of the food taken from the mouth to the stomach as a result of sequential and coordinated movements. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Rehabilitation, Stability
- What is being tested?
- Exercises Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2023to 30 Oct 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over 18 years old and volunteering.
- Having a Mini-Mental test score of 24 and above
Who cannot join
- Having a history of cervical trauma, cervical disc herniation, and osteoarthritis
- Having a history of additional disease that interferes with assessments and physical activity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University
Zonguldak, Central, 67000
About this study
Swallowing; It is a complex, dynamic, sensorimotor process involving more than 30 muscles located bilaterally in the oral, pharyngeal, and esophageal regions and involving the safe delivery of the food taken from the mouth to the stomach as a result of sequential and coordinated movements. The cervical region is important in terms of swallowing function, as it acts as a bridge between the oral and esophageal structures through the pharynx, hosts the larynx and upper respiratory tract, which plays an important role in safe swallowing, and contributes to the stabilization and preservation of posture thanks to the muscles in its structure. Craniocervical flexion (CCF) occurs at the atlantooccipital joint and upper cervical segments such as C1-2. While superficial muscles such as the SCM and anterior scalene muscles contract in cervical flexion, deep muscles such as the longus colli and capitis, which are mainly primary cervical stabilizer muscles, are activated in CCF. CCF is a movement felt as flexion in the upper part of the cervical region with a slight retraction of the chin. It is also known that the suprahyoid muscles are activated in CCF. Swallowing in the CCF posture has been shown to occur with less suprahyoid muscle activation. The cervical region must provide proper alignment, posture, and stabilization for effective and safe swallowing. Postural changes in the cervical region, and changes in the position of the hyoid bone cause changes in gravity, oropharyngeal structures, and muscle length-tension relationship, thereby changing the dynamics of swallowing function. Therefore, it is not possible to consider the cervical region separately from the swallowing function. However, the focus of the exercises to be chosen for the cervical region is different and the effects that are likely to occur may also be different. There is no study in the literature on the activation of superficial and deep muscles activated during swallowing of craniocervical flexion training exercises, which aim to improve cervical region mechanics by focusing especially on deep cervical flexors. The aim of this study is to investigate the effect of craniocervical flexion training (CCF) on swallowing-related structures in healthy individuals.
Read the detailed description
Swallowing; It is a complex, dynamic, sensorimotor process involving more than 30 muscles bilaterally located in the oral, pharyngeal, and esophageal regions, and involving the safe delivery of food taken from the mouth to the stomach as a result of sequential and coordinated movements. The cervical region is important in terms of swallowing function as it acts as a bridge between the mouth and esophagus structures through the pharynx, contains the larynx and upper respiratory tract, which plays an important role in safe swallowing, and contributes to stabilization. Maintaining posture thanks to the muscles in their structure. Craniocervical flexion (CCF) occurs at the atlantooccipital joint and upper cervical segments such as C1-2. In cervical flexion, the superficial muscles such as the SCM and anterior scalene muscles contract, whereas in CCF, mainly deep muscles such as the longus colli and capitis, which are the primary cervical stabilizer muscles, are activated. CCF is a movement felt as flexion in the upper part of the cervical region with slight retraction of the chin. It is also known that the suprahyoid muscles are activated in CCF. It has been shown that swallowing in the CCF stance occurs with less suprahyoid muscle activation. For effective and safe swallowing, the cervical region must provide proper alignment, posture, and stabilization. Postural changes in the cervical region and changes in the position of the hyoid bone cause changes in gravity, oropharyngeal structures, and muscle length-tension relationship, thereby changing the dynamics of swallowing function. Therefore, it is not possible to consider the cervical region separately from the swallowing function. However, as the focus of the exercises to be chosen for the cervical region is different, the possible effects may also be different. There are no studies in the literature on the activation of superficial and deep muscles activated during swallowing of craniocervical flexion training exercises, which aim to improve cervical region mechanics, especially by focusing on deep cervical flexors. The aim of this study is to investigate the effect of craniocervical flexion training (CCF) on swallowing structures in healthy individuals. At least 50 people meeting the inclusion criteria of Zonguldak Bülent Ecevit University will be included in the study and will be equally divided into groups by randomization. After the individuals included in the study have read and accepted the informed consent form, the following evaluations will be applied first. Evaluations begin with filling out the demographic data form, cervical region normal joint range of motion, cervical region muscle strength, cervical region posture analysis, craniocervical flexion test, activity score and performance value of deep cervical flexor muscles, evaluation of suprahyoid muscles by superficial EMG evaluation method, water drinking test Evaluation of swallowing function will be done with Assessments will take 25-30 minutes. After the initial evaluations, the participants will be randomized by the closed envelope method and divided into the exercise group and the control group. As stated in the literature, 20 sessions of KSF training will be given to the study group for 4 weeks. No intervention will be made to the control group during this period. After the exercise sessions are completed, the same evaluations will be repeated for both groups.
- Conditions
- Dysphagia, Rehabilitation, Stability
- Being tested
- Exercises Group
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercises GroupBehavioural
A Pressure Biofeedback Device will be used in CCF training to increase awareness and focus on the desired muscle. After the person is brought to the hook position, the pressurized biofeedback device will be placed in the middle position between the craniocervical and cervical vertebrae or horizontally so that the protrusion between the earlobe and the chin is removed. It is inflated to a standard 20 mmHg to ensure surface-to-longitudinal contact. Participants are taught the correct craniocervical flexion movement without first working the superficial muscles. The patient is then asked to look with their eyes slightly toward the chest cavity. During the exercises, starting from 20 mmHg and increasing by 2 mmHg, the desired level of 30 mmHg will be reached. At each level, the movement is continued for 10 seconds, resting for 3-5 seconds, 10 repetitions are required. If the same level is maintained for 10 seconds and 10 repetitions, the next level is passed.
| Study group | Role | What they receive |
|---|---|---|
| Exercises Group | Experimental | As stated in the literature, 20 sessions of KSF training will be given to the study group for 4 weeks. Receives: Behavioral: Exercises Group |
| Control Group | No intervention | Participants in the control group will not receive intervention throughout the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface Electromyographic Measurements of the Suprahyoid Muscles
yEMG, which provides practical objective data and provides electrical activation information directly from the relevant muscles, will measure the activation development in the muscles during the maximum voluntary isometric contractions to be made during a standard activity (drinking 10 ml of water). The EMG measurement to be applied to the participants will be done outside working hours in a way that will not disrupt routine patient functioning. The electrodes to be used in EMG will be covered by the researchers. This assessment will be applied before the start of the exercise program and at the end of the exercise program at the end of the 4th week.
Measured: 4 months
Secondary outcomes (4)
Evaluation of Normal Joint Range of Motion of the Cervical Region
The range of motion of the cervical region (flexion, extension, right and left lateral flexion, right and left rotation) will be evaluated by the goniometer, as indicated in the literature, by placing the patient in a suitable position in a quiet and calm environment. The measurement will be repeated 3 times and the average values will be taken.
Measured: 4 months
Evaluation of Cervical Region Muscle Strength
Cervical flexion, cervical extension, cervical right and left lateral flexion, cervical right and left rotation will be evaluated by manual muscle test, by giving the patient an appropriate position in an appropriate environment.
Measured: 4 months
Cervical Posture Analysis
Anterior and lateral cervical postural analysis will be performed. In the anterior posture analysis, deviation to the right or left according to the relationship between the chin and the suprasternal pit and the height difference of both shoulders will be evaluated with the anterior gaze. In the lateral posture analysis, protraction and retraction of the shoulders with forward or backward deviation will be evaluated according to the shoulder joint vertex-auricle relationship with the lateral gaze.
Measured: 4 months
Craniocervical Flexion Test (CCFT)
the uninflated pressure sensor (Stabilizer, Chattanooga, USA) is placed between the projection of the earlobe and the chin and inflated to the initial pressure of 20 mmHg. This is standard pressure that is sufficient to fill the gap between the neck and the surface to be tested but will not increase lordosis. The instrument provides feedback and guidance to the patient to perform the five phases required for testing. The movement is done lightly and slowly as if to nod the head (as if to say yes). The CSFT will be used to test the activation and endurance of the deep neck flexors in progressive increments of 2 mmHg from 20 mmHg to 30 mmHg, maintaining isometric contractions at progressive pressures.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start15 Feb 2023
- Primary completion20 Feb 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARZUCAN TOKSAL, Zonguldak Bulent Ecevit University
- Investigators
- Arzucan Toksal, Phd Candidate, Study director, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782803
- Sponsor's protocol ID
- ZonguldakBulentEcevitU
- Status last verified
- Oct 2023
- First submitted
- 7 Mar 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jull GA, O'Leary SP, Falla DL. Clinical assessment of the deep cervical flexor muscles: the craniocervical flexion test. J Manipulative Physiol Ther. 2008 Sep;31(7):525-33. doi: 10.1016/j.jmpt.2008.08.003.
PubMed 18804003Kilinc HE, Unver B. Effects of Craniocervical Flexion on Suprahyoid and Sternocleidomastoid Muscle Activation in Different Exercises. Dysphagia. 2022 Dec;37(6):1851-1857. doi: 10.1007/s00455-022-10453-1. Epub 2022 Apr 26.
PubMed 35471669
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Craniocervical Flexion Training on Suprahyoid Muscles in Healthy Individuals
- ClinicalTrials.gov ID
- NCT05782803
- Acronym / sponsor ID
- ZonguldakBulentEcevitU
- Conditions
- Dysphagia, Rehabilitation, Stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 24 Mar 2023 (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.
Swallowing; It is a complex, dynamic, sensorimotor process involving more than 30 muscles located bilaterally in the oral, pharyngeal, and esophageal regions and involving the safe delivery of the food taken from the mouth to the stomach as a result of sequential and coordinated movements. The cervical region is important in terms of swallowing function, as it acts as a bridge between the oral and esophageal structures through the pharynx, hosts the larynx and upper respiratory tract, which plays an important role in safe swallowing, and contributes to the stabilization and preservation of posture thanks to the muscles in its structure. Craniocervical flexion (CCF) occurs at the atlantooccipital joint and upper cervical segments such as C1-2. While superficial muscles such as the SCM and anterior scalene muscles contract in cervical flexion, deep muscles such as the longus colli and capitis, which are mainly primary cervical stabilizer muscles, are activated in CCF. CCF is a movement felt as flexion in the upper part of the cervical region with a slight retraction of the chin. It is also known that the suprahyoid muscles are activated in CCF. Swallowing in the CCF posture has been shown to occur with less suprahyoid muscle activation. The cervical region must provide proper alignment, posture, and stabilization for effective and safe swallowing. Postural changes in the cervical region, and changes in the position of the hyoid bone cause changes in gravity, oropharyngeal structures, and muscle length-tension relationship, thereby changing the dynamics of swallowing function. Therefore, it is not possible to consider the cervical region separately from the swallowing function. However, the focus of the exercises to be chosen for the cervical region is different and the effects that are likely to occur may also be different. There is no study in the literature on the activation of superficial and deep muscles activated during swallowing of craniocervical flexion training exercises, which aim to improve cervical region mechanics by focusing especially on deep cervical flexors. The aim of this study is to investigate the effect of craniocervical flexion training (CCF) on swallowing-related structures in healthy individuals.
Detailed description
Swallowing; It is a complex, dynamic, sensorimotor process involving more than 30 muscles bilaterally located in the oral, pharyngeal, and esophageal regions, and involving the safe delivery of food taken from the mouth to the stomach as a result of sequential and coordinated movements. The cervical region is important in terms of swallowing function as it acts as a bridge between the mouth and esophagus structures through the pharynx, contains the larynx and upper respiratory tract, which plays an important role in safe swallowing, and contributes to stabilization. Maintaining posture thanks to the muscles in their structure. Craniocervical flexion (CCF) occurs at the atlantooccipital joint and upper cervical segments such as C1-2. In cervical flexion, the superficial muscles such as the SCM and anterior scalene muscles contract, whereas in CCF, mainly deep muscles such as the longus colli and capitis, which are the primary cervical stabilizer muscles, are activated. CCF is a movement felt as flexion in the upper part of the cervical region with slight retraction of the chin. It is also known that the suprahyoid muscles are activated in CCF. It has been shown that swallowing in the CCF stance occurs with less suprahyoid muscle activation. For effective and safe swallowing, the cervical region must provide proper alignment, posture, and stabilization. Postural changes in the cervical region and changes in the position of the hyoid bone cause changes in gravity, oropharyngeal structures, and muscle length-tension relationship, thereby changing the dynamics of swallowing function. Therefore, it is not possible to consider the cervical region separately from the swallowing function. However, as the focus of the exercises to be chosen for the cervical region is different, the possible effects may also be different. There are no studies in the literature on the activation of superficial and deep muscles activated during swallowing of craniocervical flexion training exercises, which aim to improve cervical region mechanics, especially by focusing on deep cervical flexors. The aim of this study is to investigate the effect of craniocervical flexion training (CCF) on swallowing structures in healthy individuals. At least 50 people meeting the inclusion criteria of Zonguldak Bülent Ecevit University will be included in the study and will be equally divided into groups by randomization. After the individuals included in the study have read and accepted the informed consent form, the following evaluations will be applied first. Evaluations begin with filling out the demographic data form, cervical region normal joint range of motion, cervical region muscle strength, cervical region posture analysis, craniocervical flexion test, activity score and performance value of deep cervical flexor muscles, evaluation of suprahyoid muscles by superficial EMG evaluation method, water drinking test Evaluation of swallowing function will be done with Assessments will take 25-30 minutes. After the initial evaluations, the participants will be randomized by the closed envelope method and divided into the exercise group and the control group. As stated in the literature, 20 sessions of KSF training will be given to the study group for 4 weeks. No intervention will be made to the control group during this period. After the exercise sessions are completed, the same evaluations will be repeated for both groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercises Group | Experimental | Behavioral: Exercises GroupAs stated in the literature, 20 sessions of KSF training will be given to the study group for 4 weeks. |
| Control Group | No intervention | –Participants in the control group will not receive intervention throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being over 18 years old and volunteering.
- Having a Mini-Mental test score of 24 and above
Key exclusion criteria (2 listed)
- Having a history of cervical trauma, cervical disc herniation, and osteoarthritis
- Having a history of additional disease that interferes with assessments and physical activity
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 |
|---|---|---|
| Exercises GroupA Pressure Biofeedback Device will be used in CCF training to increase awareness and focus on the desired muscle. After the person is brought to the hook position, the pressurized biofeedback device will be placed in the middle position between the craniocervical and cervical vertebrae or horizontally so that the protrusion between the earlobe and the chin is removed. It is inflated to a standard 20 mmHg to ensure surface-to-longitudinal contact. Participants are taught the correct craniocervical flexion movement without first working the superficial muscles. The patient is then asked to look with their eyes slightly toward the chest cavity. During the exercises, starting from 20 mmHg and increasing by 2 mmHg, the desired level of 30 mmHg will be reached. At each level, the movement is continued for 10 seconds, resting for 3-5 seconds, 10 repetitions are required. If the same level is maintained for 10 seconds and 10 repetitions, the next level is passed. | Behavioural | Exercises Group |
Primary outcome
Surface Electromyographic Measurements of the Suprahyoid Muscles
Time frame: 4 months
yEMG, which provides practical objective data and provides electrical activation information directly from the relevant muscles, will measure the activation development in the muscles during the maximum voluntary isometric contractions to be made during a standard activity (drinking 10 ml of water). The EMG measurement to be applied to the participants will be done outside working hours in a way that will not disrupt routine patient functioning. The electrodes to be used in EMG will be covered by the researchers. This assessment will be applied before the start of the exercise program and at the end of the exercise program at the end of the 4th week.
4 secondary outcomes
Evaluation of Normal Joint Range of Motion of the Cervical Region
Time frame: 4 months
Evaluation of Cervical Region Muscle Strength
Time frame: 4 months
Cervical Posture Analysis
Time frame: 4 months
Craniocervical Flexion Test (CCFT)
Time frame: 4 months
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 31 Oct 2023.
- Background: PubMed 18804003Jull GA, O'Leary SP, Falla DL. Clinical assessment of the deep cervical flexor muscles: the craniocervical flexion test. J Manipulative Physiol Ther. 2008 Sep;31(7):525-33. doi: 10.1016/j.jmpt.2008.08.003.
- Background: PubMed 35471669Kilinc HE, Unver B. Effects of Craniocervical Flexion on Suprahyoid and Sternocleidomastoid Muscle Activation in Different Exercises. Dysphagia. 2022 Dec;37(6):1851-1857. doi: 10.1007/s00455-022-10453-1. Epub 2022 Apr 26.
- Individual participant dataSharing planned: No
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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.
Arzucan Toksal, Phd Candidate study director
Zonguldak Bulent Ecevit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises Group in people with Dysphagia and Rehabilitation, run by Zonguldak Bulent Ecevit 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 2 inclusion and 2 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 31 Oct 2023. 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?
Surface Electromyographic Measurements of the Suprahyoid Muscles (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05782803, which also lists 2 linked publications.
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 31 Oct 2023.