AzTrials
AzTrials

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).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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.

Orkun Tüfekçi, PT, PhD(c) contact

5319502648

orkuntf@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Hacettepe University

    Çankaya, Ankara

    Orkun Tüfekçi, PT, PhD(c), 05319502648, orkuntf@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07182981
Study groupRoleWhat they receive
Cases diagnosed with sclerodermaChild 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.

  1. 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

  2. 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. 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

  4. 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

  5. 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

  6. 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

  7. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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.

  1. First posted19 Sep 2025
  2. Study start4 Aug 2025
  3. Primary completionAug 2027 (estimated)
  4. Study completion4 Aug 2027 (estimated)

Resources

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
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in