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

Hasan Kalyoncu University

Status: Completed

Conditions: Down Syndrome

Treatments: Other: Therapeutic Yoga Group; Other: Routine Physiotherapy Group; Other: Orofacial Treatment Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06352151

2022-041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

1. Grup: Routine Physiotherapy Group

Experimental group

Description:

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

Treatment:

Other: Routine Physiotherapy Group

2.Group: Orofacial Treatment Group

Experimental group

Description:

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.

Treatment:

Other: Orofacial Treatment Group

3.Group: Therapeutic Yoga Group

Experimental group

Description:

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.

Treatment:

Other: Therapeutic Yoga Group