Down SyndromeNCT06352151
Effects of Orofacial Therapy and Therapeutic Yoga in Children With Down Syndrome
A study testing Routine Physiotherapy Group, Orofacial Treatment Group and Therapeutic Yoga Group in people with Down Syndrome, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Routine Physiotherapy Group, Orofacial Treatment Group and Therapeutic Yoga Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- 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.
- 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.
- 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.
- Conditions
- Down Syndrome
- Being tested
- Routine Physiotherapy Group, Orofacial Treatment Group, Therapeutic Yoga Group
- Keywords
- Myofunctional Therapy, Yoga, Down Syndrome, Quality of Life, Swallowing, Sleep Habits
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Physiotherapy GroupOther
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 GroupOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1. Grup: Routine Physiotherapy Group | Experimental | Children with Down Syndrome receive routine physiotherapy treatment in special education centers. Receives: 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. Receives: 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. Receives: Other: Therapeutic Yoga Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 8 weeks,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Oct 2023
- Primary completion28 Oct 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YASEMİN KOTEVOĞLU, Hasan Kalyoncu University
- Investigators
- Aysenur Tuncer, PhD, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352151
- Sponsor's protocol ID
- 2022-041
- Status last verified
- Aug 2024
- First submitted
- 2 Apr 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06352151
- Acronym / sponsor ID
- 2022-041
- Conditions
- Down Syndrome
- Keywords
- Myofunctional Therapy, Yoga, Down Syndrome, Quality of Life, Swallowing, Sleep Habits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Grup: Routine Physiotherapy Group | Experimental | Other: Routine Physiotherapy GroupChildren with Down Syndrome receive routine physiotherapy treatment in special education centers. |
| 2.Group: Orofacial Treatment Group | Experimental | Other: Orofacial Treatment GroupThe 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. |
| 3.Group: Therapeutic Yoga Group | Experimental | Other: Therapeutic Yoga GroupThe 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Physiotherapy GroupChildren 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. | Other | 1. Grup: Routine Physiotherapy Group |
| Orofacial Treatment GroupThe 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 | Other | 2.Group: Orofacial Treatment Group |
| Therapeutic Yoga GroupThe therapeutic yoga group receives therapeutic yoga treatment and routine physiotherapy treatment. Children with Down syndrome will be given yoga exercises suitable for their age. | Other | 3.Group: Therapeutic Yoga Group |
Primary outcome
The Pediatric Functional Independence Measure
Time frame: Baseline, 8 weeks,12 weeks
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.
Pediatric Eating Assessment Tool-10
Time frame: Baseline, 8 weeks, 12 weeks
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.
Children's Sleep Habits Questionnaire
Time frame: Baseline, 8 weeks,12 weeks
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.
The Health-Related Quality of Life Scale-KIDSCREEN-27
Time frame: Baseline, 8 weeks,12 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysenur Tuncer, PhD study director
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Physiotherapy Group, Orofacial Treatment Group and Therapeutic Yoga Group in people with Down Syndrome, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pediatric Functional Independence Measure (time frame: Baseline, 8 weeks,12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.