NCT05782803

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

5 days

First QC Date

March 7, 2023

Last Update Submit

October 30, 2023

Conditions

Outcome Measures

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.

    4 months

Secondary Outcomes (4)

  • Evaluation of Normal Joint Range of Motion of the Cervical Region

    4 months

  • Evaluation of Cervical Region Muscle Strength

    4 months

  • Cervical Posture Analysis

    4 months

  • Craniocervical Flexion Test (CCFT)

    4 months

Study Arms (2)

Exercises Group

EXPERIMENTAL

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

Behavioral: Exercises Group

Control Group

NO INTERVENTION

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

Interventions

Exercises GroupBEHAVIORAL

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.

Exercises Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University

Zonguldak, Central, 67000, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 18804003BACKGROUND
  • 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.

    PMID: 35471669BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Arzucan Toksal, Phd Candidate

    Zonguldak Bulent Ecevit University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 24, 2023

Study Start

February 15, 2023

Primary Completion

February 20, 2023

Study Completion

October 30, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations