Investigating the Relationship Between the Biopsychosocial Status of Patients Diagnosed With Scleroderma and Their Chewing and Swallowing Performance
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Hacettepe University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Pediatric Eating Assessment Scale (PEDI-EAT-10)
Study Overview
Brief 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. 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 7 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Cases diagnosed with scleroderma,
- •Cases aged 7-18 years will be included.
Exclusion Criteria
- •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:
- •Inclusion Criteria:
- •Individuals diagnosed with scleroderma,
- •Individuals over the age of 18 will be included.
- •Exclusion Criteria:
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Family(Two weeks)
- Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Patient(Two weeks)
- Childhood Health Assessment Questionnaire (CHAQ)(Two weeks)
- Mouth Handicap in Systemic Sclerosis Questionnaire (MHIIS)(Two weeks)
- Modified Hand Mobility in Scleroderma Test (mHAMIS)(Two weeks)
- Juvenile Arthritis Quality of Life Questionnaire (JAQQ)(Two weeks)
- Modified Rodnan skin score (MRSS)(Two weeks)
- Localized Scleroderma Assessment Tool (LoSCAT)(Two weeks)
- Fonseca Anamnestic Questionnaire(Two weeks)
- Child and Adolescent Scale of Participation (CASP)(Two weeks)
- Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)(Two weeks)
- Short Form-36 (SF-36)(Two weeks)
- Scleroderma Health Assessment Questionnaire (SHAQ)(Two weeks)
- Hospital Anxiety and Depression Scale (HADS)(Two weeks)
- Pain Catastrophizing Scale-Parent (PCS-P)(Two weeks)
- Central Sensitization Scale (CSS)(Two weeks)
Investigators
Orkun Tüfekçi
Principal Investigator, PT, PhD(c)
Hacettepe University