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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06278025
Other study ID # GO 19/833
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date February 1, 2024

Study information

Verified date March 2024
Source Atilim University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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). Exclusion Criteria: - 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.

Study Design


Intervention

Diagnostic Test:
assessment
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.

Locations

Country Name City State
Turkey Atilim University Ankara Incek

Sponsors (1)

Lead Sponsor Collaborator
Atilim University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary dcf muscle strenght 1 day
Primary dcf endurance 1 day
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