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CompletedNCT05782803Updated Oct 31, 2023

Investigation of the Effect of Craniocervical Flexion Training on Suprahyoid Muscles in Healthy Individuals

An interventional study of Exercises Group in Dysphagia, Rehabilitation and Stability, sponsored by Zonguldak Bulent Ecevit University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-31.

Sponsored by Zonguldak Bulent Ecevit University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Dysphagia
  • Rehabilitation
  • Stability

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03

In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's enrollment of 50 is below the median of 60 across 471 interventional studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

Zonguldak Bulent Ecevit University is the lead sponsor of 96 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Being over 18 years old and volunteering.
  • Having a Mini-Mental test score of 24 and above

Exclusion criteria

Exclusion Criteria:

  • Having a history of cervical trauma, cervical disc herniation, and osteoarthritis
  • Having a history of additional disease that interferes with assessments and physical activity
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Exercises Group

    As stated in the literature, 20 sessions of KSF training will be given to the study group for 4 weeks.

    Behavioral: Exercises Group

  • No intervention
    Control Group

    Participants in the control group will not receive intervention throughout the study.

Interventions

  • BehavioralExercises Group

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 months

Secondary outcomes

  1. 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.

    Time frame: 4 months

  2. 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.

    Time frame: 4 months

  3. 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.

    Time frame: 4 months

  4. 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.

    Time frame: 4 months

07

Study locations

1 site
  • Zonguldak Bülent Ecevit University
    Zonguldak, Central 67000, Turkey
08

References and documents

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 18804003 ↗
  • Kilinc 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05782803
Lead sponsor
Zonguldak Bulent Ecevit University
Responsible party
ARZUCAN TOKSAL (Lecturer, Zonguldak Bulent Ecevit University) — Principal investigator
First posted
Mar 24, 2023
Start date
Feb 15, 2023
Primary completion
Feb 20, 2023
Completion
Oct 30, 2023
Last update
Oct 31, 2023

Study contacts

Arzucan Toksal, Phd Candidate
study director · Zonguldak Bulent Ecevit University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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