Systemic Sclerosis (SSc)NCT07182981
Patients Diagnosed With Scleroderma and Their Chewing and Swallowing Performance
An observational study of Systemic Sclerosis (SSc) and Scleroderma, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. 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 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 Patients Diagnosed With Scleroderma and Their Chewing and Swallowing Performance
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.
- Conditions
- Systemic Sclerosis (SSc), Scleroderma, Scleroderma (Limited and Diffuse), Scleroderma, Localized, Swallowing
- Being tested
- Questionnaire application for child and adult scleroderma patients
- Keywords
- Juvenile scleroderma, scleroderma, systemic sclerosis
- 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 application for child and adult scleroderma patientsOther
Scales 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 application for child and adult scleroderma patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Eating Assessment Scale (PEDI-EAT-10)
It is used to evaluate swallowing disorders in pediatric patients. It was developed as the pediatric version of the EAT-10, which is used in adults. The PEDI-EAT-10 comprises 10 questions, each with a Likert scale ranging from 0 to 4 (0 = no problem, 4 = severe problem). The total score is calculated out of 40 points.
Measured: Two weeks
Chewing and Swallowing Test for Children (TOMASS-C)
It is a measurement tool developed specifically for children to assess chewing performance. TOMASS-C is a standardized method that quantitatively evaluates the chewing and swallowing of a solid food (cracker) in the pediatric population. During the test, the following parameters will be observed and recorded:
- Number of bites
- Number of chewing cycles
- Number of swallows
- Task completion time (in seconds)
Measured: Two weeks
3-Ounce Water Swallow Challenge
It is a commonly used method for assessing oropharyngeal dysphagia and aspiration risk. Subjects must swallow 3 ounces (90 cc) of water without interruption. Failure to complete the task, coughing, choking, or exhibiting a wet-gurgling voice quality within 1 minute during or after the test is included. Subjects who can drink 90 cc of water completely and in one go without coughing, choking, or drinking the water in portions have completed the test.
Measured: Two weeks
Turkish Eating Assessment Tool (T-EAT-10)
It is a questionnaire consisting of 10 questions with a Likert scale ranging from 0 to 4 (0 = no problem, 4 = severe problem). The total score is calculated out of 40 points by summing the responses given to each question. A score of 3 or higher is considered abnormal in the questionnaire.
Measured: Two weeks
Test of Masticating and Swallowing Solids (TOMASS)
The test evaluates how many bites it takes an individual to eat a biscuit while sitting upright, how many chewing cycles they perform, how many times they swallow, and the total time from bite to swallow. The number of bites, number of chewing cycles, number of swallows, and total time will be calculated.
Measured: Two weeks
Maximum Mouth Opening (MMO)
After ensuring that individuals open their mouths as wide as possible, the distance between the incisal edges of the central incisors in the upper and lower jaws will be measured in millimeters using a ruler, and the values will be recorded.
Measured: Two weeks
Dysphagia Limit (DL)
Individuals are given liquids in volumes of 5, 10, 15, 20, 25, 30, 35, 40, and 45 mL using a graduated syringe, and they are asked to swallow the liquid. The maximum amount of liquid that can be swallowed during a single movement of the thyroid cartilage is determined. In healthy individuals, the normal dysphagia limit is more than 20 mL. If a person can normally swallow 20 mL, the dysphagia limit is considered normal.
Measured: Two weeks
Secondary outcomes (16)
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). In the Localized Skin Severity Index, it 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
Mouth Handicap in Systemic Sclerosis Questionnaire (MHIIS)
It consists of 12 items. Each item is scored from 0 to 4, with response options of "Never (0)", "Rarely (1)", "Sometimes (2)", "Usually (3)", and "Always (4)". The total score ranges from 0 to 48. It covers three areas: mouth opening (questions 1, 3, 4, 5, 6), dry mouth (questions 2, 7, 8, 9, 10), and aesthetic concerns (questions 11, 12). Higher scores reflect greater limitations in oral functions.
Measured: Two weeks
Fonseca Anamnestic Questionnaire
Participants are asked to answer 10 questions without any time constraints. Each answer is scored as "yes = 10," "no = 0," and "sometimes = 5." Based on the total score, participants are classified as TMR-Absent (0-15), Mild-TMR (20-40), Moderate-TMR (45-65), and Severe-TMR (70-100).
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
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 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
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 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
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
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
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
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.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- NCT07182981
- Sponsor's protocol ID
- SBA 25/528
- 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 Patients Diagnosed With Scleroderma and Their Chewing and Swallowing Performance
- ClinicalTrials.gov ID
- NCT07182981
- Acronym / sponsor ID
- SBA 25/528
- Conditions
- Systemic Sclerosis (SSc), Scleroderma, Scleroderma (Limited and Diffuse), Scleroderma, Localized, Swallowing
- Keywords
- Juvenile scleroderma, scleroderma, systemic sclerosis
- 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.
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.
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 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
- Advanced heart/lung/liver/kidney disease, neurological disease, and malignancies
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 application for child and adult scleroderma patientsScales will be applied to cases diagnosed with scleroderma | Other | Cases diagnosed with scleroderma |
Primary outcome
Pediatric Eating Assessment Scale (PEDI-EAT-10)
Time frame: Two weeks
It is used to evaluate swallowing disorders in pediatric patients. It was developed as the pediatric version of the EAT-10, which is used in adults. The PEDI-EAT-10 comprises 10 questions, each with a Likert scale ranging from 0 to 4 (0 = no problem, 4 = severe problem). The total score is calculated out of 40 points.
Chewing and Swallowing Test for Children (TOMASS-C)
Time frame: Two weeks
It is a measurement tool developed specifically for children to assess chewing performance. TOMASS-C is a standardized method that quantitatively evaluates the chewing and swallowing of a solid food (cracker) in the pediatric population. During the test, the following parameters will be observed and recorded: * Number of bites * Number of chewing cycles * Number of swallows * Task completion time (in seconds)
3-Ounce Water Swallow Challenge
Time frame: Two weeks
It is a commonly used method for assessing oropharyngeal dysphagia and aspiration risk. Subjects must swallow 3 ounces (90 cc) of water without interruption. Failure to complete the task, coughing, choking, or exhibiting a wet-gurgling voice quality within 1 minute during or after the test is included. Subjects who can drink 90 cc of water completely and in one go without coughing, choking, or drinking the water in portions have completed the test.
Turkish Eating Assessment Tool (T-EAT-10)
Time frame: Two weeks
It is a questionnaire consisting of 10 questions with a Likert scale ranging from 0 to 4 (0 = no problem, 4 = severe problem). The total score is calculated out of 40 points by summing the responses given to each question. A score of 3 or higher is considered abnormal in the questionnaire.
Test of Masticating and Swallowing Solids (TOMASS)
Time frame: Two weeks
The test evaluates how many bites it takes an individual to eat a biscuit while sitting upright, how many chewing cycles they perform, how many times they swallow, and the total time from bite to swallow. The number of bites, number of chewing cycles, number of swallows, and total time will be calculated.
Maximum Mouth Opening (MMO)
Time frame: Two weeks
After ensuring that individuals open their mouths as wide as possible, the distance between the incisal edges of the central incisors in the upper and lower jaws will be measured in millimeters using a ruler, and the values will be recorded.
Dysphagia Limit (DL)
Time frame: Two weeks
Individuals are given liquids in volumes of 5, 10, 15, 20, 25, 30, 35, 40, and 45 mL using a graduated syringe, and they are asked to swallow the liquid. The maximum amount of liquid that can be swallowed during a single movement of the thyroid cartilage is determined. In healthy individuals, the normal dysphagia limit is more than 20 mL. If a person can normally swallow 20 mL, the dysphagia limit is considered normal.
16 secondary outcomes
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
Short Form-36 (SF-36)
Time frame: Two weeks
Scleroderma Health Assessment Questionnaire (SHAQ)
Time frame: Two weeks
Central Sensitization Scale (CSS)
Time frame: Two weeks
Hospital Anxiety and Depression Scale (HADS)
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?
Pediatric Eating Assessment Scale (PEDI-EAT-10) (time frame: Two weeks). The study lists 7 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.