CompletedNot Applicable

Effects of Orofacial Therapy and Therapeutic Yoga in Children With Down Syndrome

Turkey (Türkiye)30 participantsStarted 2023-10-01

Plain-language summary

The study aims to compare the effects of orofacial therapy and therapeutic yoga on swallowing, sleep habits, and quality of life in children with Down syndrome.

Who can participate

Age range

5 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of Down syndrome * Age between 5 and 12 years old * Scoring 4 or higher on the pEAT-10 questionnaire * Obtained parental consent form * Ability of the child to cooperate Exclusion Criteria: * Conditions that would impede assessment or communication (such as cognitive problems, psychiatric issues, etc.). * Children who have undergone any surgery related to orofacial structures and/or received orthodontic treatment. * Those with a history of trauma (whiplash injury, condylar trauma, fractures). * Children who have received orofacial-related physical therapy treatment within less than 6 months.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Pediatric Functional Independence Measure

Timeframe: Baseline, 8 weeks,12 weeks

Pediatric Eating Assessment Tool-10

Timeframe: Baseline, 8 weeks, 12 weeks

Children's Sleep Habits Questionnaire

Timeframe: Baseline, 8 weeks,12 weeks

The Health-Related Quality of Life Scale-KIDSCREEN-27

Timeframe: Baseline, 8 weeks,12 weeks

Trial details

NCT IDNCT06352151

SponsorHasan Kalyoncu University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-28

View on ClinicalTrials.gov More Down Syndrome trials

Who can participate

Age range

5 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The Pediatric Functional Independence Measure

Timeframe: Baseline, 8 weeks,12 weeks

Pediatric Eating Assessment Tool-10

Timeframe: Baseline, 8 weeks, 12 weeks

Children's Sleep Habits Questionnaire

Timeframe: Baseline, 8 weeks,12 weeks

The Health-Related Quality of Life Scale-KIDSCREEN-27

Timeframe: Baseline, 8 weeks,12 weeks