About this trial
It is recommended to focus on the physical functionality, chewing, and swallowing performance of individuals diagnosed with scleroderma. There is a need to address children and adults diagnosed with scleroderma comprehensively and to evaluate them on a biopsychosocial basis to support their disease management. The aim was to assess the biopsychosocial characteristics of both children and adults diagnosed with scleroderma and to examine their chewing and swallowing performance.
Additionally, this study aims to identify effective scales that can be used in future research to assess chewing and swallowing in individuals diagnosed with scleroderma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Cases diagnosed with scleroderma,
Cases aged 7-18 years will be included.
Disqualifiers
Advanced heart/lung/liver/kidney disease, neurological disease, and malignancies
Cases that are not willing to participate in the study will be excluded.
Having participated in a regular exercise program for the past 3 months
Individuals who are not willing to participate in the study
Trial population
The study population will consist of individuals who come to the university hospital for routine controls.
Trial design
Cohort
Prospective
Treatments tested in this trial
Questionnaire application for child and adult scleroderma patients
Other interventionScales will be applied to cases diagnosed with scleroderma
Treatment groups
Trial outcomes
Primary outcomes
Pediatric Eating Assessment Scale (PEDI-EAT-10)
It is used to evaluate swallowing disorders in pediatric patients. It was developed as the pediatric version of the EAT-10, which is used in adults. The PEDI-EAT-10 comprises 10 questions, each with a Likert scale ranging from 0 to 4 (0 = no problem, 4 = severe problem). The total score is calculated out of 40 points.
Chewing and Swallowing Test for Children (TOMASS-C)
It is a measurement tool developed specifically for children to assess chewing performance. TOMASS-C is a standardized method that quantitatively evaluates the chewing and swallowing of a solid food (cracker) in the pediatric population. During the test, the following parameters will be observed and recorded: * Number of bites * Number of chewing cycles * Number of swallows * Task completion time (in seconds)
3-Ounce Water Swallow Challenge
It is a commonly used method for assessing oropharyngeal dysphagia and aspiration risk. Subjects must swallow 3 ounces (90 cc) of water without interruption. Failure to complete the task, coughing, choking, or exhibiting a wet-gurgling voice quality within 1 minute during or after the test is included. Subjects who can drink 90 cc of water completely and in one go without coughing, choking, or drinking the water in portions have completed the test.
Turkish Eating Assessment Tool (T-EAT-10)
It is a questionnaire consisting of 10 questions with a Likert scale ranging from 0 to 4 (0 = no problem, 4 = severe problem). The total score is calculated out of 40 points by summing the responses given to each question. A score of 3 or higher is considered abnormal in the questionnaire.
Secondary outcomes
Modified Rodnan skin score (MRSS)
A pediatric and adult rheumatologist assessed it. The MRSS evaluates skin thickening in 17 body regions, graded from 0 (normal) to 3 (severe skin thickening). The total score ranges from 0 to 51, with increased scores indicating poor skin involvement.
Localized Scleroderma Assessment Tool (LoSCAT)
LoSCAT consists of two sections: the modified Localized Skin Severity Index, which measures disease activity, and the Localized Scleroderma Damage Index, which assesses damage (usually scored between 0 and 3). In the Localized Skin Severity Index, it evaluates the color of the lesion border for erythema, skin thickness, and the presence of new lesions or lesion extension. In the Localized Scleroderma Damage Index, three areas of cutaneous damage are combined to obtain a score. These areas evaluate hyperpigmentation or hypopigmentation, whichever is more prominent, as well as dermal atrophy, subcutaneous atrophy, and dyspigmentation.
Mouth Handicap in Systemic Sclerosis Questionnaire (MHIIS)
It consists of 12 items. Each item is scored from 0 to 4, with response options of "Never (0)", "Rarely (1)", "Sometimes (2)", "Usually (3)", and "Always (4)". The total score ranges from 0 to 48. It covers three areas: mouth opening (questions 1, 3, 4, 5, 6), dry mouth (questions 2, 7, 8, 9, 10), and aesthetic concerns (questions 11, 12). Higher scores reflect greater limitations in oral functions.
Fonseca Anamnestic Questionnaire
Participants are asked to answer 10 questions without any time constraints. Each answer is scored as "yes = 10," "no = 0," and "sometimes = 5." Based on the total score, participants are classified as TMR-Absent (0-15), Mild-TMR (20-40), Moderate-TMR (45-65), and Severe-TMR (70-100).
Sponsors and contacts
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