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

NCT06352151 | Completed

• 1 other identifier: 2022-041
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Keywords

Myofunctional Therapy; Yoga; Down Syndrome; Quality of Life; Swallowing; Sleep Habits

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

1. Grup: Routine Physiotherapy Group

EXPERIMENTAL

Children with Down Syndrome receive routine physiotherapy treatment in special education centers.

Other: Routine Physiotherapy Group

2.Group: Orofacial Treatment Group

EXPERIMENTAL

The orofacial treatment group receives therapeutic orofacial treatment in addition to routine physiotherapy treatment. For orofacial therapy, sessions will be conducted twice a week for eight weeks, lasting 30-45 minutes, totaling 16 sessions.

Other: Orofacial Treatment Group

3.Group: Therapeutic Yoga Group

EXPERIMENTAL

The therapeutic yoga group receives therapeutic yoga treatment and routine physiotherapy treatment. Sixteen sessions were planned twice a week for eight weeks, each 30-45 minutes.

Other: Therapeutic Yoga Group

Interventions

Routine Physiotherapy Group OTHER

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.

1. Grup: Routine Physiotherapy Group

Orofacial Treatment Group OTHER

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

2.Group: Orofacial Treatment Group

Therapeutic Yoga Group OTHER

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.

3.Group: Therapeutic Yoga Group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, 27410, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Aysenur Tuncer, PhD

  Hasan Kalyoncu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: October 1, 2023
• Primary Completion: October 28, 2024
• Study Completion: March 30, 2025
• Last Updated: September 8, 2025

Record last verified: 2024-08

Locations

TU (1)