Comparing orofacial therapy and yoga for children with Down syndrome
Comparison of the Effects of Orofacial Therapy and Therapeutic Yoga on Swallowing, Sleeping Habits and Quality of Life in Children With Down Syndrome
NA · Hasan Kalyoncu University · NCT06352151
This study is testing whether orofacial therapy or therapeutic yoga can improve swallowing, sleep, and overall quality of life for children with Down syndrome aged 5 to 12.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 5 Years to 12 Years |
| Sex | All |
| Sponsor | Hasan Kalyoncu University (other) |
| Locations | 1 site (Gaziantep) |
| Trial ID | NCT06352151 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of orofacial therapy and therapeutic yoga on swallowing, sleep habits, and quality of life in children diagnosed with Down syndrome. Children aged 5 to 12 will be randomly assigned to one of three groups: routine physiotherapy, orofacial therapy combined with routine physiotherapy, or therapeutic yoga combined with routine physiotherapy. Assessments will be conducted before therapy, after 8 weeks of therapy, and at a 12-week follow-up to measure the effectiveness of the interventions. Parental consent is required for participation, and children must meet specific inclusion criteria.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 12 years with a diagnosis of Down syndrome who can cooperate during assessments.
Not a fit: Patients with cognitive or psychiatric issues that impede communication or assessment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve swallowing, sleep quality, and overall quality of life for children with Down syndrome.
How similar studies have performed: While there is limited data on the specific combination of therapies used in this study, similar approaches have shown promise in improving quality of life in children with developmental disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Gaziantep
- Hasan Kalyoncu University — Gaziantep, Turkey (RECRUITING)
Study contacts
- Study coordinator: Aysenur Tuncer, PhD
- Email: aysenur.tuncer@hku.edu.tr
- Phone: +903422118080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Down Syndrome, Myofunctional Therapy, Yoga, Quality of Life, Swallowing, Sleep Habits