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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06197451
Other study ID # 187765
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 19, 2023
Est. completion date May 19, 2024

Study information

Verified date January 2024
Source Gazi University
Contact Muserrefe Nur Keles, PhD
Phone 5426622464
Email muserrefkeles19@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to M.D. Validity of the Turkish version of the Anderson Dysphagia Inventory for the Turkish population, reliability, and cultural adaptation.


Description:

Oropharyngeal dysphagia (OD) is a common finding in patients with neurogenic disorders. Swallowing disorder can be acute or chronic in nature. For example, acute OD is observed in patients after stroke, head trauma, neurosurgical intervention, or in patients with Guillain-Barré syndrome. Chronic OD may develop in patients who do not recover after a stroke. Degenerative OD, Parkinson's disease, amyotrophic lateral sclerosis, myasthenia gravis, Huntington's disease, myotonic dystrophy type 1 and multiple sclerosis It is seen in patients with progressive neurological diseases. The prevalence of OD in neurogenic patients varies from 3% to 50% in stroke patients and up to almost 100% in patients with Huntington's disease. The OD can lead to weight loss, malnutrition, social isolation, aspiration pneumonia, and reduced health-related quality of life (QoL). Some studies have reported that dysphagia-specific QoL is weakly associated with OD severity measured using, among other things, fiberoptic endoscopic evaluation of swallowing (FEES) and videofluoroscopy of swallowing (VFS). Therefore, dysphagia-specific QoL questionnaires used alongside these instrumental assessments add value by providing insight into patients' perception of OD, which can be taken into account in the treatment plan. There are dysphagia-specific quality-of-life questionnaires that are actively used today: Swallowing Quality of Life Questionnaire (SWAL-QOL, 44 items), Swallowing Disability Index (30 items), Dysphagia Handicap Index (25 items) and M.D. Anderson Dysphagia Inventory (MDADI, 20 items). Multidisciplinary dysphagia clinics in our country mostly focus on the head and neck. It is visited by patients with OD of oncological or neurological origin.The M. D. Anderson dysphagia inventory is an easier inventory to perform since it has a smaller number of questions and contains more standard questions compared to other currently used questionnaires. Other questionnaires, such as the SWAL-QOL-TR and the Swallowing Disability Index, are longer than the MDADI and take more time to complete. The purpose of this study is M.D. Validity of the Turkish version of the Anderson Dysphagia Inventory for the Turkish population, reliability and cultural adaptation.


Recruitment information / eligibility

Status Recruiting
Enrollment 170
Est. completion date May 19, 2024
Est. primary completion date February 19, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: Group 1: - Diagnosed with neurologic disorder - Able to speak, read, understand and write in Turkish - History of dysphagia during 6 months Group 2: - Able to speak, read, understand and write in Turkish - Healthy adults Exclusion Criteria: - Mini Mental State Examination score below 23 points - History of head and neck cancer (HNC), - Age below 18 or above 85 years.

Study Design


Intervention

Other:
Turkish Version of M. D. Anderson Dysphagia Inventory
Turkish Validation and Cultural Adaptation of M. D. Anderson Dysphagia Inventory in Neurologic Patients

Locations

Country Name City State
Turkey Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500 Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Subject Demographics and Medical History The median values of age and ratio of gender in all groups. Medical Diagnoses. Baseline
Primary Turkish Version of M. D. Anderson Dysphagia Inventory The M.D Anderson Dysphagia Inventory is a self-administered, psychometrically validated dysphagia-specific questionnaire for cancer patients that is designed to assess the impact of dysphagia on health-related quality of life . Like the original English version, the validated Turkish translation of the M.D. Anderson Dysphagia Inventory consists of 20 items pooled in 4 subscales: the global scale
(1 item); the functional scale (5 items); the physical scale (8 items); and the emotional scale (6 items)The global question was scored individually, and the mean score of each subscale (emotional, physical, and functional) was multiplied by 20 to obtain a total score with a range from zero (extremely low functioning) to 100 (high functioning). A higher M. D. Anderson Dysphagia Inventory score is indicative of better day-to-day functioning and quality of life.
Baseline
Primary Turkish Version of M. D. Anderson Dysphagia Inventory The M.D Anderson Dysphagia Inventory is a self-administered, psychometrically validated dysphagia-specific questionnaire for cancer patients that is designed to assess the impact of dysphagia on health-related quality of life . Like the original English version, the validated Turkish translation of the M.D. Anderson Dysphagia Inventory consists of 20 items pooled in 4 subscales: the global scale
(1 item); the functional scale (5 items); the physical scale (8 items); and the emotional scale (6 items)The global question was scored individually, and the mean score of each subscale (emotional, physical, and functional) was multiplied by 20 to obtain a total score with a range from zero (extremely low functioning) to 100 (high functioning). A higher M. D. Anderson Dysphagia Inventory score is indicative of better day-to-day functioning and quality of life.
Two weeks
Secondary The Swallowing Quality-of-Life Questionnaire The Swallowing Quality-of-Life Questionnaire was designed to evaluate the impact of dysphagia on health-related quality of life in dysphagic patients. It consists of 44 items divided among 11 domains: general burden (2 items); food selection (2 items); eating duration (2 items); eating desire (3 items); fear of eating (4 items); sleep (2 items); fatigue (3 items); communication (2 items); mental health (5 items); social functioning (5 items); and frequency of symptoms (14 items). Each item is scored on a 5-point scale: the higher the score, the better the swallow-related quality of life. Completion of the questionnaire takes 15-30 min. The Turkish version of the Swallowing Quality of Life is considered the gold standard for determining dysphagia specific quality of life in patients with dysphagia. Baseline
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