Patients Diagnosed With Scleroderma and Their Chewing and Swallowing Performance

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7+
SponsorHacettepe University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaire application for child and adult scleroderma patients

    Other intervention

    Scales will be applied to cases diagnosed with scleroderma

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Cases diagnosed with scleroderma1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Two weeks
2

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)

Time frame
Two weeks
3

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.

Time frame
Two weeks
4

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.

Time frame
Two weeks

Secondary outcomes

1

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.

Time frame
Two weeks
2

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.

Time frame
Two weeks
3

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.

Time frame
Two weeks
4

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).

Time frame
Two weeks

Other outcomes

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