An observational study in Systemic Sclerosis (SSc), Scleroderma and Scleroderma (Limited and Diffuse), sponsored by Hacettepe University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Hacettepe University · Observational
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.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 145 observational studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of individuals who come to the university hospital for routine controls.
*For a child diagnosed with scleroderma*
Inclusion Criteria:
Exclusion Criteria:
*For adults diagnosed with scleroderma*
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child and adult scleroderma patients who visited the rheumatology outpatient clinic at a university hospital will complete a questionnaire.
Other: Questionnaire and functionality application for child and adult scleroderma patients
Scales and functionality tests will be applied to cases diagnosed with scleroderma
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Two weeks
Childhood Health Assessment Questionnaire (CHAQ)
It assesses the functional abilities of children diagnosed with rheumatic diseases in their daily living activities. It consists of eight subscales (dressing and personal care, standing up, eating, walking, body care, reaching, grasping, activities) (0-3) and also assesses pain and general well-being using a visual analog scale (0-100). A high score indicates low functionality.
Time frame: Two weeks
Juvenile Arthritis Quality of Life Questionnaire (JAQQ)
It consists of 74 items covering various health domains, including physical functioning, emotional well-being, and general symptoms. The items are divided into four dimensions related to the child's quality of life: gross motor function (GMF), fine motor function (FMF), psychosocial function (PF), and systemic or general symptoms (SGS). Each domain is scored on a Likert-type scale from 1 to 7; higher scores indicate poorer health-related quality of life. There is also a "not applicable to me" option for the items. The scale also includes a pain measurement (10 cm Visual Analog Scale (VAS)) to assess pain, but this score is not included in the total score.
Time frame: Two weeks
Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Patient
It is a patient/parent-centered measurement method that helps assess the patient's biopsychosocial aspects, such as disease activity, posture, functional and psychosocial status, fatigue, and school performance. The results from the questions are used to assess the functional status of children, while their psychosocial status is recorded based on their answers to 21 questions (ranging from 0 to 358). A high score indicates a poor psychosocial status.
Time frame: Two weeks
Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Family
JAB-Q is a multidimensional questionnaire and a parent (family) form. Developed in Turkish by Ünal and colleagues, the questionnaire is completed by one of the child's parents. The family form evaluates the parents' biopsychosocial status from their own perspective and provides scores ranging from 0 to 102. Higher scores indicate a worse biopsychosocial status.
Time frame: Two weeks
Pain Catastrophizing Scale-Parent (PCS-P)
It is assessed using a 5-point Likert scale ranging from 0 (never) to 4 (always) and consists of 13 items. Similar to the child questionnaire, it assesses 3 domains: rumination, magnification, and helplessness. A total score between 0 and 52 is obtained; higher scores reflect a higher level of catastrophizing in parents.
Time frame: Two weeks
Child and Adolescent Scale of Participation (CASP)
It is a 20-question survey that evaluates the community participation of children and adolescents in school, neighborhood, and local settings. The survey is divided into four sections: 6 questions about home participation, four questions on neighborhood and community involvement, five questions regarding school participation, and five questions on home and community engagement. It is rated on a scale of "expected for their age (full participation), somewhat limited, very limited, unable to participate, and inapplicable." The survey is completed by the child's family or primary caregiver. The person filling out the questionnaire is asked to select the answer that best describes the child's level of participation. The assessment is scored out of 100 points, with higher scores reflecting a greater level of participation.
Time frame: Two weeks
Scleroderma Health Assessment Questionnaire (SHAQ)
It was developed by adding five questions to the HAQ regarding Raynaud's phenomenon, digital ulcers, gastrointestinal, pulmonary, and general scleroderma symptoms, to be rated on a 15 cm line. The SHAQ total score ranges from 0 to 3. A high score indicates low functionality.
Time frame: Two weeks
Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)
It was standardized as a biopsychosocial assessment tool and is scored using a 5-point Likert scale, with each item rated from 0 to 4 points. A high total score on the 30-item scale indicates a high level of biopsychosocial impact.
Time frame: Two weeks
Short Form-36 (SF-36)
It will be used to determine an individual's quality of life levels. Each sub-parameter is scored between 0 and 100 points, with a high score indicating good health status. The SF-36 scale has eight sub-parameters: general health perception, physical function, social function, pain, mental health, role difficulty due to physical reasons, role difficulty due to emotional reasons, and vitality. It contains 11 questions consisting of a total of 36 items.
Time frame: Two weeks
Central Sensitization Scale (CSS)
It is a 40-item scale, scored on a 0-4 Likert scale, that assesses symptoms related to central sensitization. A score above 40 is interpreted as an indicator of central sensitization.
Time frame: Two weeks
Hospital Anxiety and Depression Scale (HADS)
It consists of fourteen questions, with odd-numbered questions assessing anxiety and even-numbered questions assessing depression. The options are scored from 0 to 3, with higher scores indicating a worse emotional state. The Turkish cut-off values for the scale are 10 for the anxiety subscale and 7 for the depression subscale.
Time frame: Two weeks
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
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). The Localized Skin Severity Index 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
Modified Hand Mobility in Scleroderma Test (mHAMIS)
It is a functional test developed specifically for scleroderma to assess an individual's hand function. It evaluates four specific hand movements (finger flexion, finger extension, finger abduction, and dorsal extension). Scores range from 0 (normal) to 3 (complete failure) for each movement, with a total score ranging from 0 to 12.
Time frame: Two weeks
Pain Catastrophizing Scale-Children (PCS-C)
It consists of 13 items that describe the different thoughts and feelings children may experience when they feel pain. The questionnaire assesses three areas: rumination, magnification, and helplessness. All items are rated on a scale from 0 (never) to 4 (always). Higher scores reflect more catastrophic beliefs about pain. The total score can range from 0 to 48.
Time frame: Two weeks
Transition Readiness Assessment Questionnaire (TRAQ)
It includes 20 items divided into five subscales. These subscales are related to "Management of Treatment" (the first four items), "Scheduling Appointments" (items 5-11), "Monitoring Health Issues" (items 12-15), "Communication with Healthcare Personnel" (items 16-17), and "Management of Daily Activities" (items 18-20). The scale uses a 5-point Likert-type scale and has a total score range of 20 to 100. The scale score reflects the level of readiness for transitioning to adult care.
Time frame: Two weeks
Pain Catastrophizing Scale
It includes 13 items that describe different thoughts and feelings that may occur when pain is experienced. The questionnaire assesses three areas: rumination, magnification, and helplessness. All items are rated on a scale from 0 (never) to 4 (always). Higher scores indicate more catastrophic pain beliefs. The total score ranges from 0 to 52.
Time frame: Two weeks
Clinical Frailty Scale
It assesses elements such as comorbidity, cognitive impairment, and disability. Frailty scores range from 1 to 9, with one meaning 'very fit' and nine meaning 'terminally ill'. A score of 5 or above is considered a sign of frailty.
Time frame: Two weeks
Frailty Scale
FRAIL is a 5-item scale developed by Morley and colleagues to evaluate frailty. Each question is scored as 0 or 1 point. The total score ranges from 0 to 5 points (0 points = Fit, 1-2 points = Pre-frail, 3-5 points = Frail).
Time frame: Two weeks
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Aug 2027, 24 months after the start.
Of 59 non-industry observational studies under Scleroderma, Systemic, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 80. This study's planned 24 months is below that.
Counting every sponsor, half of 61 studies reached it within 44 months; a quarter within 15 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.