- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06491407
RISK FACTOR ANALYSIS OF CHEWING AND SWALLOWING PERFORMANCE IN GERIATRICS
ANALYSIS OF FACTORS INFLUENCING CHEWING AND SWALLOWING PERFORMANCE IN GERIATRICS WITHIN THE SCOPE OF INTERNATIONAL CLASSİFİCATION OF FUNCTIONING, DISABILITY, AND HEALTH
Various structural and functional problems in neural, sensory and perceptual, cardiovascular, pulmonary, gastrointestinal, endocrine, and musculoskeletal systems occur in geriatrics not associated with a specific disease. One of the problems observed in geriatrics is chewing and swallowing disorders. Failure to detect changes in chewing and swallowing performance in elderly individuals at an early stage may lead to chewing and swallowing disorders and serious complications in later stages. Therefore, it is necessary to comprehensively and systematically address the possible factors affecting chewing and swallowing performance in geriatric individuals.
The first aim of the study is to analyze the factors affecting chewing and swallowing performance in geriatric individuals within the scope of the International Classification of Functioning, Disability, and Health (ICF). The second aim of the study is to create a dysphagia risk prediction model for geriatric individuals based on the results of the analyses to be conducted.
In the study, the dependent variables, chewing performance, will be evaluated with the Chewing and Swallowing Test of Solids, and swallowing performance will be assessed with the Repetitive Saliva Swallowing Test and Dysphagia Limit. Independent variables affecting chewing and swallowing performance have been considered within the scope of the ICF, and all possible factors determined for both geriatrics and swallowing have been listed, and the evaluation parameters and assessment tools have been decided. The evaluation parameters have been categorized under ICF headings such as personal factors, body structures, body functions, activity and participation, and environmental factors, and the evaluations to be conducted have been divided into two groups: geriatric and physiotherapy evaluations. The geriatric evaluations are part of routine geriatric assessment and do not include any specific evaluation for the study. Physiotherapy evaluations will be applied in a certain order to use time efficiently and will take approximately 35-45 minutes. Through geriatric and physiotherapy evaluations, a holistic assessment of participants within the scope of ICF will be ensured.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: sena N begen, MSc
- Phone Number: 05380929826
- Email: sena.begen7@gmail.com
Study Contact Backup
- Name: sena N begen, msc
- Phone Number: 05380929826
- Email: sena.begen@atilim.edu.tr
Study Locations
-
-
Incek
-
Ankara, Incek, Turkey, 06830
- Recruiting
- Atılım Uiveristy
-
Contact:
- Sena N Begen
- Phone Number: +905380929826
- Email: sena.begen7@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- being voluntary to participation,
- Being over 65 years old,
- Understanding and following simple instructions,
- Being able to walk independently for 4 meters.
Exclusion Criteria:
- Having a problem that prevents communication and/or following simple instructions.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Geriatrics
>65 years old individuals
|
In the study, the dependent variables, chewing performance, will be evaluated with the Chewing and Swallowing Test of Solids, and swallowing performance will be assessed with the Repetitive Saliva Swallowing Test and Dysphagia Limit.
Independent variables affecting chewing and swallowing performance have been considered within the scope of the ICF, and all possible factors determined for both geriatrics and swallowing have been listed, and the evaluation parameters and assessment tools have been decided.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Chewing performance
Time Frame: 1 day
|
1 day
|
|
Swallowing performance
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Deccriptive informations
Time Frame: 1 day
|
1 day
|
|
Fragility Assessment
Time Frame: 1 day
|
1 day
|
|
posture assessment
Time Frame: 1 day
|
1 day
|
|
oral structure assessment
Time Frame: 1 day
|
1 day
|
|
cognitive assessment
Time Frame: 1 day
|
1 day
|
|
emotional status assessment
Time Frame: 1 day
|
1 day
|
|
appetite assessment
Time Frame: 1 day
|
1 day
|
|
sleep assessment
Time Frame: 1 day
|
1 day
|
|
hearing and vision assessment
Time Frame: 1 day
|
1 day
|
|
taste and smell assessment
Time Frame: 1 day
|
1 day
|
|
intraoral sensation assessment
Time Frame: 1 day
|
1 day
|
|
Temporomandibular pain assessment
Time Frame: 1 day
|
1 day
|
|
fonation assessment
Time Frame: 1 day
|
1 day
|
|
articulation assessment
Time Frame: 1 day
|
1 day
|
|
Respiratory assessment
Time Frame: 1 day
|
1 day
|
|
exercise tolerance assessment
Time Frame: 1 day
|
1 day
|
|
Feeding and oral intake assessment
Time Frame: 1 day
|
1 day
|
|
Laryngeopharyngeal reflux assessment
Time Frame: 1 day
|
1 day
|
|
oral health assessment
Time Frame: 1 day
|
1 day
|
|
oral dryness assessment
Time Frame: 1 day
|
1 day
|
|
swallow problems assessment
Time Frame: 1 day
|
1 day
|
|
Temporomandibular joint range of motion
Time Frame: 1 day
|
1 day
|
|
jaw openin force
Time Frame: 1 day
|
1 day
|
|
hand grip
Time Frame: 1 day
|
1 day
|
|
5 repetetion sit to stand test
Time Frame: 1 day
|
1 day
|
|
Timed up and go
Time Frame: 1 day
|
1 day
|
|
basic functional independance assessment
Time Frame: 1 day
|
1 day
|
|
enstrümental functional independance assessment
Time Frame: 1 day
|
1 day
|
|
social support assessment
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Selen serel arslan, Prof, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBA 23/421
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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