- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06278025
Dysphagia and Deep Cervical Flexor Muscles
Comparison of Deep Cervical Flexor Muscle Strength and Endurance in Patients With and Without Neurogenic Dysphagia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Incek
-
Ankara, Incek, Turkey, 06830
- Atilim University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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).
|
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 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).
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
dcf muscle strenght
Time Frame: 1 day
|
1 day
|
|
dcf endurance
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: sena N begen, Atilim University, Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
- Study Director: selen serel arslan, Hacettepe University Faculty of Physical Therapy and Rehabilitation Ankara, TURKEY
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 19/833
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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