NCT06352151

Effects of Orofacial Therapy and Therapeutic Yoga in 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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hasan Kalyoncu University · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

At special education and rehabilitation centers, children diagnosed with Down syndrome will undergo initial assessment, and those meeting the inclusion criteria will be included in the study following parental voluntary consent. Measurement assessments will be conducted three times: before therapy, after therapy (at week 8), and at a follow-up at week 12. To ensure a fair and unbiased distribution, children participating in the study will be randomly assigned to their respective groups using a sealed envelope method, a widely accepted and transparent randomization technique. 1. Grup: Routine Physiotherapy (PT) Group - Receiving routine physiotherapy treatment. Children who receive routine physiotherapy treatment in special education centers will be evaluated at the end of the 8th session following the treatment. After 12 weeks, the control will be in the form of an evaluation. 2. Grup: Orofacial Therapy + Routine PT Group - Receiving orofacial therapy and routine physiotherapy treatment. For the orofacial therapy, sessions will be held twice a week for eight weeks, with each session lasting 30-45 minutes, totaling 16 sessions. This structured and intensive therapy schedule is designed to provide a comprehensive evaluation of the therapy's effectiveness. Secondary evaluations will be conducted following the 8th treatment session, and a follow-up evaluation will be performed after 12 weeks. 3. Grup: Therapeutic Yoga Group + Routine PT Group - Receiving therapeutic yoga and routine physiotherapy treatments. The therapeutic yoga group at special education centers will also meet twice weekly for eight weeks, each lasting 30-45 minutes, for 16 sessions. Secondary evaluations will be conducted following the 8th treatment session, and a follow-up evaluation will be performed after 12 weeks.

Conditions

• Down Syndrome

Interventions

Type	Name	Description
OTHER	Routine Physiotherapy Group	Children with Down syndrome who receive routine physical therapy treatment in special education centers will undergo evaluation after eight weeks of treatment, followed by a control evaluation after 12 weeks.
OTHER	Orofacial Treatment Group	The orofacial treatment group receives therapeutic orofacial treatment in addition to routine physiotherapy treatment. Each week, one or two target exercises will be taught to the child with Down syndrome, and the exercises will gradually increase throughout the process. Parental involvement will be encouraged during the treatment to ensure active participation in therapy. The goals of the therapy are as follows: First Goal: Nasal hygiene and Sleep hygiene education Second Goal: Nasal Breathing Exercise Training Third Goal: Creating Awareness of Tongue Resting Position Fourth Goal: Creating Lip Position Awareness - Lip Exercises Goal Five: Chewing Muscle Exercises Sixth Goal: Strengthening the Soft Palate Seventh Goal: Reshaping Correct Swallowing
OTHER	Therapeutic Yoga Group	The therapeutic yoga group receives therapeutic yoga treatment and routine physiotherapy treatment. Children with Down syndrome will be given yoga exercises suitable for their age.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-10-28
• Completion: 2025-03-30
• First posted: 2024-04-08
• Last updated: 2025-09-08

Locations

1 site across 1 country: Turkey (Türkiye)