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Recruiting NCT07183072

Patients Diagnosed With Scleroderma: Physical Performance and Functionality

— 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 and functionality 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 Individuals Diagnosed With Scleroderma and Their Physical Performance and Functionality

Overview

Physical functionality and performance are important for 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. In light of all this literature, the aim was to evaluate the biopsychosocial characteristics of both pediatric and adult scleroderma patients and to examine their physical performance and functionality. Additionally, this study aims to identify effective tests that can be used in future research to assess physical performance and functionality in individuals diagnosed with scleroderma.

Interventions

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

Primary outcome measures

  • 6-Minute Walk Test [Time frame: Two weeks]
  • Timed Up and Go Test [Time frame: Two weeks]
  • 10-Step Stair Climbing Test [Time frame: Two weeks]
  • 10-meter walk test [Time frame: Two weeks]
  • 30-second sit-to-stand test [Time frame: Two weeks]
  • Glittre Activities of Daily Living Test [Time frame: Two weeks]
Secondary outcome measures (12)
  • Childhood Health Assessment Questionnaire (CHAQ) [Time frame: Two weeks]
  • Juvenile Arthritis Quality of Life Questionnaire (JAQQ) [Time frame: Two weeks]
  • Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Patient [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]
  • Scleroderma Health Assessment Questionnaire (SHAQ) [Time frame: Two weeks]
  • Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ) [Time frame: Two weeks]
  • Short Form-36 (SF-36) [Time frame: Two weeks]
  • Central Sensitization Scale (CSS) [Time frame: Two weeks]
  • Hospital Anxiety and Depression Scale (HADS) [Time frame: Two weeks]
  • Modified Rodnan skin score (MRSS) [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: NCT07183072 · SBA 25/529

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗