Patients Diagnosed With Scleroderma and Their Chewing and Swallowing Performance
Investigating the Relationship Between the Biopsychosocial Status of Patients Diagnosed With Scleroderma and Their Chewing and Swallowing Performance
1 other identifier
observational
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 4, 2025
CompletedFirst Submitted
Initial submission to the registry
September 13, 2025
CompletedFirst Posted
Study publicly available on registry
September 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 4, 2027
September 19, 2025
August 1, 2025
2 years
September 13, 2025
September 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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.
Two weeks
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)
Two weeks
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.
Two weeks
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.
Two weeks
Test of Masticating and Swallowing Solids (TOMASS)
The test evaluates how many bites it takes an individual to eat a biscuit while sitting upright, how many chewing cycles they perform, how many times they swallow, and the total time from bite to swallow. The number of bites, number of chewing cycles, number of swallows, and total time will be calculated.
Two weeks
Maximum Mouth Opening (MMO)
After ensuring that individuals open their mouths as wide as possible, the distance between the incisal edges of the central incisors in the upper and lower jaws will be measured in millimeters using a ruler, and the values will be recorded.
Two weeks
Dysphagia Limit (DL)
Individuals are given liquids in volumes of 5, 10, 15, 20, 25, 30, 35, 40, and 45 mL using a graduated syringe, and they are asked to swallow the liquid. The maximum amount of liquid that can be swallowed during a single movement of the thyroid cartilage is determined. In healthy individuals, the normal dysphagia limit is more than 20 mL. If a person can normally swallow 20 mL, the dysphagia limit is considered normal.
Two weeks
Secondary Outcomes (16)
Modified Rodnan skin score (MRSS)
Two weeks
Localized Scleroderma Assessment Tool (LoSCAT)
Two weeks
Mouth Handicap in Systemic Sclerosis Questionnaire (MHIIS)
Two weeks
Fonseca Anamnestic Questionnaire
Two weeks
Modified Hand Mobility in Scleroderma Test (mHAMIS)
Two weeks
- +11 more secondary outcomes
Study Arms (1)
Cases diagnosed with scleroderma
Child and adult scleroderma patients who visited the rheumatology outpatient clinic at a university hospital will complete a questionnaire.
Interventions
Scales will be applied to cases diagnosed with scleroderma
Eligibility Criteria
The study population will consist of individuals who come to the university hospital for routine controls.
You may qualify if:
- Cases diagnosed with scleroderma,
- Cases aged 7-18 years will be included.
You may not qualify if:
- 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
- For adults diagnosed with scleroderma:
- Individuals diagnosed with scleroderma,
- Individuals over the age of 18 will be included.
- Advanced heart/lung/liver/kidney disease, neurological disease, and malignancies
- Individuals who 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University
Çankaya, Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, PT, PhD(c)
Study Record Dates
First Submitted
September 13, 2025
First Posted
September 19, 2025
Study Start
August 4, 2025
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 4, 2027
Last Updated
September 19, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share