- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07209800
- Original Trial
Sensory Therapy for Chewing in Children
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:
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Meram
-
Konya, Meram, Turkey (Türkiye), 40336
- Nezahat Keleşoğlu Faculty of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sensory integration therapy
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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
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.
|
Pre-intervention assessment: Before the start of the therapy. Post-intervention assessment: Immediately after the completion of the therapy program (4 weeks).
|
|
Sociodemographic data:
Time Frame: Before the start of the therapy.
|
Age, sex, height, weight, and diagnosis.
|
Before the start of the therapy.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Neslihan Altuntaş Yılmaz, Assistant Professor, Necmettin Erbakan University
- Study Director: Ahmet Sami Güven, Professor, Necmettin Erbakan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NEU-PT2025-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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