Chewing Difficulties in ChildrenNCT07209800
Sensory Therapy for Chewing in Children
A study testing Sensory integration therapy in people with Chewing Difficulties in Children and Feeding Behavior Challenges, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Brief Summary The goal of this study is to learn if whole-body sensory integration therapy can improve chewing skills and mealtime behaviors in children with chewing difficulties. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Chewing Difficulties in Children, Feeding Behavior Challenges, Oral-motor Dysfunction
- What is being tested?
- Sensory integration therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Feb 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with chewing difficulties aged around 5 years (approx. 55-69 months, based on mean ± SD)
- Medically stable and able to participate in feeding sessions
- Parental consent obtained
Who cannot join
- Children with severe medical conditions or genetic syndromes affecting feeding
- Children receiving other intensive feeding or sensory interventions during the study
- Inability to sit or participate in the evaluation sessions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nezahat Keleşoğlu Faculty of Health Sciences
Konya, Meram, 40336
About this study
Official title: Effectiveness of Whole-Body Sensory Integration Therapy on Chewing Function and Feeding Behaviors in Children With Chewing Disorders
Brief Summary
The goal of this study is to learn if whole-body sensory integration therapy can improve chewing skills and mealtime behaviors in children with chewing difficulties. The main questions it aims to answer are:
Read more
Does the therapy help children chew food better?
Does it make mealtimes shorter and more efficient?
Participants will:
Attend individual sensory integration therapy sessions for 60 minutes, three times a week for 4 weeks
Take part in exercises such as vibration, crawling through a tunnel, therapeutic brushing, joint and oral exercises, and sensory activities
Be observed for chewing performance and report meal duration and daily meal frequency before and after the therapy
Researchers will compare the results from before and after the therapy to see if chewing skills and feeding behaviors improve.
Read the detailed description
Detailed Description
The aim of this study is to evaluate the effectiveness of whole-body sensory integration therapy on chewing function, meal duration, and feeding behaviors in children with chewing difficulties. Chewing difficulties in children can arise from developmental disorders, such as cerebral palsy, autism spectrum disorder, or other neuromotor impairments. These difficulties can negatively affect nutritional intake, growth, and overall quality of life.
This study will include 31 children aged between 3 and 12 years who exhibit observable challenges in chewing or feeding. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive whole-body sensory integration therapy three times per week for 4 weeks. Each therapy session will last approximately 60 minutes and include activities designed to enhance oral-motor function, chewing skills, body coordination, balance, and sensory processing. Examples of therapy activities include:
Chewing exercises using therapy tools (e.g., chewing sticks, textured foods)
Oral-motor exercises to strengthen lips, tongue, and jaw muscles
Proprioceptive and vestibular activities such as crawling, climbing, balancing, and swinging
Play-based tasks that integrate sensory input with functional feeding activities
Parents or caregivers will be guided to support therapy exercises at home to reinforce skill acquisition.
Outcome measures will be collected at baseline and after the 4-week intervention. The primary outcome is improvement in chewing function, assessed using standardized tools suitable for pediatric populations. Secondary outcomes include changes in meal duration, frequency of meals, and overall feeding behaviors.
It is hypothesized that children receiving whole-body sensory integration therapy will demonstrate significant improvements in chewing efficiency, reduced meal times, and enhanced feeding behaviors compared to the control group. This study aims to provide evidence for the inclusion of sensory integration therapy as a clinical intervention to support feeding skills in children with chewing difficulties.
- Conditions
- Chewing Difficulties in Children, Feeding Behavior Challenges, Oral-motor Dysfunction, Impaired Chewing Function
- Being tested
- Sensory integration therapy
- Keywords
- Chewing disorder, Karaduman Chewing Performance Scale (KCPS), Oral awareness, Pediatric rehabilitation, Sensory integration therapy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory integration therapyOther
Sensory integration therapy (SIT) was delivered individually in a play-based format, three times per week for four weeks, totaling 12 sessions. Each session lasted 60 minutes, and parents were instructed to reinforce the activities at home as homework. All interventions were administered one-on-one by an experienced therapist in a therapy room. The therapist who administered the intervention did not take part in the evaluation process; therefore, the study was conducted in a single-blind manner. Before the intervention, a trust-based relationship was established with the children, and sensory activities were performed within a play context. The interventions were not limited to oral activities but aimed to support overall sensory development [8]. Based on this program, sensory integration procedures were applied at regular intervals.
| Study group | Role | What they receive |
|---|---|---|
| Sensory integration therapy | Experimental | Sensory integration therapy (SIT) was delivered individually in a play-based format, three times per week for four weeks, totaling 12 sessions. Each session lasted 60 minutes, and parents were instructed to reinforce the activities at home as homework. All interventions were administered one-on-one by an experienced therapist in a therapy room. The therapist who administered the intervention did not take part in the evaluation process; therefore, the study was conducted in a single-blind manner. Before the intervention, a trust-based relationship was established with the children, and sensory activities were performed within a play context. The interventions were not limited to oral activities but aimed to support overall sensory development [8]. Based on this program, sensory integration procedures were applied at regular intervals. Receives: Other: Sensory integration therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chewing performance:
Assessed using the Karaduman Chewing Performance Scale (KCPS).
Measured: Pre-intervention assessment: Before the start of the therapy. Post-intervention assessment: Immediately after the completion of the therapy program (4 weeks).
Meal frequency and duration
Average daily meal frequency and meal duration recorded via parent interviews.
Measured: Pre-intervention assessment: Before the start of the therapy. Post-intervention assessment: Immediately after the completion of the therapy program (4 weeks).
Sociodemographic data:
Age, sex, height, weight, and diagnosis.
Measured: Before the start of the therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Dec 2023
- Primary completion1 Nov 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chewing Difficulties in ChildrenStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study was conducted as an experimental, single-group, pretest-posttest design. Participants received whole-body sensory integration therapy, and pre- and post-intervention assessments were used to evaluate changes in chewing function and feeding behaviors
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Altuntas Yilmaz, Necmettin Erbakan University
- Investigators
- Neslihan Altuntaş Yılmaz, Assistant Professor, Principal investigator, Necmettin Erbakan UniversityAhmet Sami Güven, Professor, Study director, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209800
- Sponsor's protocol ID
- NEU-PT2025-01
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is complete; however, individual participant data (IPD) will not be publicly shared to protect participant confidentiality and ensure the security of personal data. Ethical approvals and consent forms do not cover data sharing. If requested, the corresponding author may share data on a case-by-case basis, ensuring participant confidentialit
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Whole-Body Sensory Integration Therapy on Chewing Function and Feeding Behaviors in Children With Chewing Disorders
- ClinicalTrials.gov ID
- NCT07209800
- Acronym / sponsor ID
- NEU-PT2025-01
- Conditions
- Chewing Difficulties in Children, Feeding Behavior Challenges, Oral-motor Dysfunction, Impaired Chewing Function
- Keywords
- Chewing disorder, Karaduman Chewing Performance Scale (KCPS), Oral awareness, Pediatric rehabilitation, Sensory integration therapy.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 7 Oct 2025 (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.
Brief Summary
The goal of this study is to learn if whole-body sensory integration therapy can improve chewing skills and mealtime behaviors in children with chewing difficulties. The main questions it aims to answer are:
Does the therapy help children chew food better?
Does it make mealtimes shorter and more efficient?
Participants will:
Attend individual sensory integration therapy sessions for 60 minutes, three times a week for 4 weeks
Take part in exercises such as vibration, crawling through a tunnel, therapeutic brushing, joint and oral exercises, and sensory activities
Be observed for chewing performance and report meal duration and daily meal frequency before and after the therapy
Researchers will compare the results from before and after the therapy to see if chewing skills and feeding behaviors improve.
Detailed description
Detailed Description
The aim of this study is to evaluate the effectiveness of whole-body sensory integration therapy on chewing function, meal duration, and feeding behaviors in children with chewing difficulties. Chewing difficulties in children can arise from developmental disorders, such as cerebral palsy, autism spectrum disorder, or other neuromotor impairments. These difficulties can negatively affect nutritional intake, growth, and overall quality of life.
This study will include 31 children aged between 3 and 12 years who exhibit observable challenges in chewing or feeding. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive whole-body sensory integration therapy three times per week for 4 weeks. Each therapy session will last approximately 60 minutes and include activities designed to enhance oral-motor function, chewing skills, body coordination, balance, and sensory processing. Examples of therapy activities include:
Chewing exercises using therapy tools (e.g., chewing sticks, textured foods)
Oral-motor exercises to strengthen lips, tongue, and jaw muscles
Proprioceptive and vestibular activities such as crawling, climbing, balancing, and swinging
Play-based tasks that integrate sensory input with functional feeding activities
Parents or caregivers will be guided to support therapy exercises at home to reinforce skill acquisition.
Outcome measures will be collected at baseline and after the 4-week intervention. The primary outcome is improvement in chewing function, assessed using standardized tools suitable for pediatric populations. Secondary outcomes include changes in meal duration, frequency of meals, and overall feeding behaviors.
It is hypothesized that children receiving whole-body sensory integration therapy will demonstrate significant improvements in chewing efficiency, reduced meal times, and enhanced feeding behaviors compared to the control group. This study aims to provide evidence for the inclusion of sensory integration therapy as a clinical intervention to support feeding skills in children with chewing difficulties.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study was conducted as an experimental, single-group, pretest-posttest design. Participants received whole-body sensory integration therapy, and pre- and post-intervention assessments were used to evaluate changes in chewing function and feeding behaviors
| Arm | Type | Receives |
|---|---|---|
| Sensory integration therapy | Experimental | Other: Sensory integration therapySensory integration therapy (SIT) was delivered individually in a play-based format, three times per week for four weeks, totaling 12 sessions. Each session lasted 60 minutes, and parents were instructed to reinforce the activities at home as homework. All interventions were administered one-on-one by an experienced therapist in a therapy room. The therapist who administered the intervention did not take part in the evaluation process; therefore, the study was conducted in a single-blind manner. Before the intervention, a trust-based relationship was established with the children, and sensory activities were performed within a play context. The interventions were not limited to oral activities but aimed to support overall sensory development [8]. Based on this program, sensory integration procedures were applied at regular intervals. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with chewing difficulties aged around 5 years (approx. 55-69 months, based on mean ± SD)
- Medically stable and able to participate in feeding sessions
- Parental consent obtained
Key exclusion criteria (3 listed)
- Children with severe medical conditions or genetic syndromes affecting feeding
- Children receiving other intensive feeding or sensory interventions during the study
- Inability to sit or participate in the evaluation sessions
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 |
|---|---|---|
| Sensory integration therapySensory integration therapy (SIT) was delivered individually in a play-based format, three times per week for four weeks, totaling 12 sessions. Each session lasted 60 minutes, and parents were instructed to reinforce the activities at home as homework. All interventions were administered one-on-one by an experienced therapist in a therapy room. The therapist who administered the intervention did not take part in the evaluation process; therefore, the study was conducted in a single-blind manner. Before the intervention, a trust-based relationship was established with the children, and sensory activities were performed within a play context. The interventions were not limited to oral activities but aimed to support overall sensory development [8]. Based on this program, sensory integration procedures were applied at regular intervals. | Other | Sensory integration therapy |
Primary outcome
Chewing performance:
Time frame: Pre-intervention assessment: Before the start of the therapy. Post-intervention assessment: Immediately after the completion of the therapy program (4 weeks).
Assessed using the Karaduman Chewing Performance Scale (KCPS).
Meal frequency and duration
Time frame: Pre-intervention assessment: Before the start of the therapy. Post-intervention assessment: Immediately after the completion of the therapy program (4 weeks).
Average daily meal frequency and meal duration recorded via parent interviews.
Sociodemographic data:
Time frame: Before the start of the therapy.
Age, sex, height, weight, and diagnosis.
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 7 Oct 2025.
- Individual participant dataSharing planned: No. The study is complete; however, individual participant data (IPD) will not be publicly shared to protect participant confidentiality and ensure the security of personal data. Ethical approvals and consent forms do not cover data sharing. If requested, the corresponding author may share data on a case-by-case basis, ensuring participant confidentialit
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.
Neslihan Altuntaş Yılmaz, Assistant Professor principal investigator
Necmettin Erbakan University
Ahmet Sami Güven, Professor study director
Necmettin Erbakan 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 Sensory integration therapy in people with Chewing Difficulties in Children and Feeding Behavior Challenges, run by Necmettin Erbakan 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 3 inclusion and 3 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 7 Oct 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?
Chewing performance: (time frame: Pre-intervention assessment: Before the start of the therapy. Post-intervention assessment: Immediately after the completion of the therapy program (4 weeks).). The study lists 3 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 7 Oct 2025.