Patients Diagnosed With Scleroderma: Physical Performance and Functionality
Investigating the Relationship Between the Biopsychosocial Status of Individuals Diagnosed With Scleroderma and Their Physical Performance and Functionality
1 other identifier
observational
50
1 country
1
Brief Summary
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.
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 (6)
6-Minute Walk Test
Participants are asked to walk as quickly as they can along a 30-meter corridor. The total distance will be measured in meters. Fatigue, pain and dyspnea will be monitored using the Modified Borg Scale.
Two weeks
Timed Up and Go Test
The time it takes for a person to get up from a chair with back support, walk 3 meters at a normal pace, and return to the chair is measured in seconds to evaluate lower extremity balance. The test will be performed 3 times.
Two weeks
10-Step Stair Climbing Test
To assess the subject's lower extremity strength and dynamic balance, the time taken to quickly climb and descend a staircase with 10 steps, each measuring 16-20 cm high and equipped with a handrail, is recorded in seconds. The test is repeated three times, and the times are recorded.
Two weeks
10-meter walk test
The individual is on a 10-meter path. The assessment is performed in three repetitions and recorded in seconds.
Two weeks
30-second sit-to-stand test
It is performed to evaluate lower extremity endurance by having the individual stand up from a chair with their arms crossed over their chest and then sit back down. The individual is instructed to repeat this as quickly as possible for 30 seconds. The score for this assessment is the number of times the person fully stands up from a sitting position with arms crossed within 30 seconds.
Two weeks
Glittre Activities of Daily Living Test
It consists of a cycle of standardized activities such as walking, carrying weights, climbing stairs, and moving objects on a shelf. The equipment required for the test includes a chair, steps, a shelf, a backpack, weights (0.5 kg-2.5 kg), and a stopwatch. The patient completes the 10-meter course created for the test for five laps, and the time is recorded.
Two weeks
Secondary Outcomes (19)
Childhood Health Assessment Questionnaire (CHAQ)
Two weeks
Juvenile Arthritis Quality of Life Questionnaire (JAQQ)
Two weeks
Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Patient
Two weeks
Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Family
Two weeks
Pain Catastrophizing Scale-Parent (PCS-P)
Two weeks
- +14 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 and functionality tests 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
Interventions
Condition Hierarchy (Ancestors)
Intervention 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