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

Down Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06352151
• Other study ID #: 2022-041
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Hasan Kalyoncu University
• Contact: Aysenur Tuncer, PhD
• Phone: +903422118080
• Email: aysenur.tuncer[@]hku.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: September 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

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.
• 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
• 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.

Locations

Country	Name	City	State
Turkey	Hasan Kalyoncu University	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Pediatric Functional Independence Measure	The Pediatric Functional Independence Measure (WeeFIM): The WeeFIM consists of 18 items across 6 separate domains. These domains include self-care, sphincter control, transfers, mobility, communication, and social-cognitive evaluations. When answering the items in the WeeFIM sections, scoring is based on whether assistance is needed during the activity, and whether any assistive devices are required. The WeeFIM scale yields scores ranging from a minimum of 18 to a maximum of 126 points.	Baseline, 8 weeks,12 weeks
Primary	Pediatric Eating Assessment Tool-10	The Pediatric Eating Assessment Tool-10 (p-EAT-10) is a scale consisting of 10 items used to screen the severity of dysphagia symptoms. Each item is scored from 0 to 4 (0=No problem and 4=Severe Problem). Normative data indicate that a p-EAT-10 score of 4 or higher indicates a risk of swallowing disorder, with higher scores indicating more severe dysphagia symptoms.	Baseline, 8 weeks, 12 weeks
Primary	Children's Sleep Habits Questionnaire	The Children's Sleep Habits Questionnaire (CSHQ) form contains 33 items, including 8 subscales. The CSHQ assesses the following subscales: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night waking, parasomnias, sleep-disordered breathing, and daytime sleepiness. The scale is filled out retrospectively by parents. A total score of 41 points is considered the cutoff point for the CSHQ, and scores above this threshold indicate that children are experiencing clinically significant sleep problems.	Baseline, 8 weeks,12 weeks
Primary	The Health-Related Quality of Life Scale-KIDSCREEN-27	The Health-Related Quality of Life Scale-KIDSCREEN-27 form is drawn from the KIDSCREEN-52 and consists of 27 questions and 5 dimensions. The dimensions of KIDSCREEN-27 include physical well-being (5 items), psychological well-being (7 items), autonomy and relationships with parents (7 items), social support and peers (4 items), and school environment (4 items). In all KIDSCREEN questionnaires, items have a 5-point Likert-type response scale (never, seldom, sometimes, often, always). An increase in score indicates a better quality of life.	Baseline, 8 weeks,12 weeks