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Recruiting NCT07182981

Patients Diagnosed With Scleroderma and Their Chewing and Swallowing Performance

— Observational Systemic Sclerosis (SSc) Scleroderma Scleroderma (Limited and Diffuse) Scleroderma, Localized

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire application for child and adult scleroderma patients.
Who it may be relevant to
Registry conditions: Systemic Sclerosis (SSc), Scleroderma, Scleroderma (Limited and Diffuse), Scleroderma, Localized. Basic parameters: from 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Investigating the Relationship Between the Biopsychosocial Status of Patients Diagnosed With Scleroderma and Their Chewing and Swallowing Performance

Overview

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.

Interventions

  • Other Questionnaire application for child and adult scleroderma patients
    Scales will be applied to cases diagnosed with scleroderma

Primary outcome measures

  • Pediatric Eating Assessment Scale (PEDI-EAT-10) [Time frame: Two weeks]
  • Chewing and Swallowing Test for Children (TOMASS-C) [Time frame: Two weeks]
  • 3-Ounce Water Swallow Challenge [Time frame: Two weeks]
  • Turkish Eating Assessment Tool (T-EAT-10) [Time frame: Two weeks]
  • Test of Masticating and Swallowing Solids (TOMASS) [Time frame: Two weeks]
  • Maximum Mouth Opening (MMO) [Time frame: Two weeks]
  • Dysphagia Limit (DL) [Time frame: Two weeks]
Secondary outcome measures (12)
  • Modified Rodnan skin score (MRSS) [Time frame: Two weeks]
  • Localized Scleroderma Assessment Tool (LoSCAT) [Time frame: Two weeks]
  • Mouth Handicap in Systemic Sclerosis Questionnaire (MHIIS) [Time frame: Two weeks]
  • Fonseca Anamnestic Questionnaire [Time frame: Two weeks]
  • Modified Hand Mobility in Scleroderma Test (mHAMIS) [Time frame: Two weeks]
  • Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Patient [Time frame: Two weeks]
  • Juvenile Arthritis Quality of Life Questionnaire (JAQQ) [Time frame: Two weeks]
  • Childhood Health Assessment Questionnaire (CHAQ) [Time frame: Two weeks]
  • Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Family [Time frame: Two weeks]
  • Pain Catastrophizing Scale-Parent (PCS-P) [Time frame: Two weeks]
  • Child and Adolescent Scale of Participation (CASP) [Time frame: Two weeks]
  • Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ) [Time frame: Two weeks]

Eligibility criteria

For a child diagnosed with scleroderma:

Inclusion criteria

  • Cases diagnosed with scleroderma,
  • Cases aged 7-18 years will be included.

Exclusion criteria

  • 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:

Inclusion criteria

  • Individuals diagnosed with scleroderma,
  • Individuals over the age of 18 will be included.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Hacettepe University — Çankaya

Identifiers

NCT: NCT07182981 · SBA 25/528

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗