Clinical trial NCT06352151: Effects of Orofacial Therapy and Therapeutic Yoga in Children With Down Syndrome
Official title: Comparison of the Effects of Orofacial Therapy and Therapeutic Yoga on Swallowing, Sleeping Habits and Quality of Life in Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Down Syndrome
Keywords: Myofunctional Therapy
Yoga
Down Syndrome
Quality of Life
Swallowing
Sleep Habits
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The Pediatric Functional Independence Measure
timeFrame: Baseline, 8 weeks,12 weeks
measure: Pediatric Eating Assessment Tool-10
timeFrame: Baseline, 8 weeks, 12 weeks
measure: Children's Sleep Habits Questionnaire
timeFrame: Baseline, 8 weeks,12 weeks
measure: The Health-Related Quality of Life Scale-KIDSCREEN-27
timeFrame: Baseline, 8 weeks,12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
affiliation: Hasan Kalyoncu University
name: Aysenur Tuncer, PhD
role: STUDY_DIRECTOR
References: