Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT06352151
Brief 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.
Study:
NCT06352151
Study Brief:
Protocol Section:
NCT06352151