Systemic Sclerosis (SSc)NCT07183072
Patients Diagnosed With Scleroderma: Physical Performance and Functionality
An observational study of Systemic Sclerosis (SSc) and Scleroderma, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Systemic Sclerosis (SSc), Scleroderma, Scleroderma (Limited and Diffuse)
- What is being tested?
- Questionnaire and functionality application for child and adult scleroderma patients
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Aug 2025to 4 Aug 2027
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of individuals who come to the university hospital for routine controls.
Who may be able to join
- Cases diagnosed with scleroderma,
- Cases aged 7-18 years will be included.
- Individuals diagnosed with scleroderma,
- Individuals over the age of 18 will be included.
Who cannot join
- 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
- Advanced heart/lung/liver/kidney disease, neurological disease, and malignancies
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Çankaya, Ankara
Orkun Tüfekçi, PT, PhD(c), 05319502648, orkuntf@gmail.com
About this study
Official title: Investigating the Relationship Between the Biopsychosocial Status of Individuals Diagnosed With Scleroderma and Their Physical Performance and Functionality
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.
- Conditions
- Systemic Sclerosis (SSc), Scleroderma, Scleroderma (Limited and Diffuse), Scleroderma, Localized, Functionality
- Being tested
- Questionnaire and functionality application for child and adult scleroderma patients
- Keywords
- Juvenile scleroderma, scleroderma, systemic sclerosis, physical performance, functionality
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse, Scleroderma, Localized, Juvenile-onset scleroderma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and functionality application for child and adult scleroderma patientsOther
Scales and functionality tests will be applied to cases diagnosed with scleroderma
| Study group | Role | What they receive |
|---|---|---|
| Cases diagnosed with scleroderma | Child and adult scleroderma patients who visited the rheumatology outpatient clinic at a university hospital will complete a questionnaire. Receives: Other: Questionnaire and functionality application for child and adult scleroderma patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Two weeks
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start4 Aug 2025
- Primary completionAug 2027 (estimated)
- Study completion4 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orkun Tüfekçi, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183072
- Sponsor's protocol ID
- SBA 25/529
- Status last verified
- Aug 2025
- First submitted
- 13 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Relationship Between the Biopsychosocial Status of Individuals Diagnosed With Scleroderma and Their Physical Performance and Functionality
- ClinicalTrials.gov ID
- NCT07183072
- Acronym / sponsor ID
- SBA 25/529
- Conditions
- Systemic Sclerosis (SSc), Scleroderma, Scleroderma (Limited and Diffuse), Scleroderma, Localized, Functionality
- Keywords
- Juvenile scleroderma, scleroderma, systemic sclerosis, physical performance, functionality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- 4 Aug 2027 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases diagnosed with scleroderma | – | Other: Questionnaire and functionality application for child and adult scleroderma patientsChild and adult scleroderma patients who visited the rheumatology outpatient clinic at a university hospital will complete a questionnaire. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of individuals who come to the university hospital for routine controls.
Key inclusion criteria (4 listed)
- Cases diagnosed with scleroderma,
- Cases aged 7-18 years will be included.
- Individuals diagnosed with scleroderma,
- Individuals over the age of 18 will be included.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and functionality application for child and adult scleroderma patientsScales and functionality tests will be applied to cases diagnosed with scleroderma | Other | Cases diagnosed with scleroderma |
Primary outcome
6-Minute Walk Test
Time frame: Two weeks
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.
Timed Up and Go Test
Time frame: Two weeks
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.
10-Step Stair Climbing Test
Time frame: Two weeks
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.
10-meter walk test
Time frame: Two weeks
The individual is on a 10-meter path. The assessment is performed in three repetitions and recorded in seconds.
30-second sit-to-stand test
Time frame: Two weeks
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.
Glittre Activities of Daily Living Test
Time frame: Two weeks
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.
19 secondary outcomes
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
Localized Scleroderma Assessment Tool (LoSCAT)
Time frame: Two weeks
Modified Hand Mobility in Scleroderma Test (mHAMIS)
Time frame: Two weeks
Pain Catastrophizing Scale-Children (PCS-C)
Time frame: Two weeks
Transition Readiness Assessment Questionnaire (TRAQ)
Time frame: Two weeks
Pain Catastrophizing Scale
Time frame: Two weeks
Clinical Frailty Scale
Time frame: Two weeks
Frailty Scale
Time frame: Two weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis (SSc) and Scleroderma, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Orkun Tüfekçi, PT, PhD(c) (5319502648, orkuntf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute Walk Test (time frame: Two weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.