NCT06278025

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

4.4 years

First QC Date

February 19, 2024

Last Update Submit

March 15, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • dcf muscle strenght

    1 day

  • dcf endurance

    1 day

Study Arms (2)

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).

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).

Diagnostic Test: assessment

Interventions

assessmentDIAGNOSTIC_TEST

DCF Muscle Strength Evaluation DCF muscle strength was determined using the 5-step Craniocervical Flexion Test (CCFT) performed with a Chattanooga Stabilizer ™ Pressure Biofeedback Unit which was developed by Jull et al. \[33, 34\]. The CCFT is based on the craniocervical flexion movement, which is provided by DCF muscle contraction. The CCFT includes 5 pressure increments starting with 20mmHg.Activation score ranges from 0 to 10. The performance index is determined by both the highest pressure level and the number of repetitions. Evaluation of the DCF Endurance The DCF endurance test, which is a valid and reliable method, was used to measure DCF muscle endurance \[36\]. Conducted in supine, endurance is measured by calculating the time (in seconds) an individual can raise their head at minimal flexion angle.

patients with dysphagia (study)patients without dysphagia (control)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

participants aged between 18 - 65 and diagnoses neurological disease will included in the study.

You may qualify if:

  • \- 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atilim University

Ankara, Incek, 06830, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Deglutition DisordersNervous System Diseases

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • sena N begen

    Atilim University, Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

    STUDY CHAIR
  • selen serel arslan

    Hacettepe University Faculty of Physical Therapy and Rehabilitation Ankara, TURKEY

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2024

First Posted

February 26, 2024

Study Start

September 1, 2019

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

March 18, 2024

Record last verified: 2024-03

Locations