Sensory Therapy for Chewing in Children

NCT ID: NCT07209800

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-02-01

Brief 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. 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.

Conditions

Chewing Difficulties in Children; Feeding Behavior Challenges; Oral-motor Dysfunction; Impaired Chewing Function

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sensory integration therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Necmettin Erbakan University

OTHER

Sponsor Role: lead

Responsible Party

Neslihan Altuntas Yilmaz

Assistant Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neslihan Altuntaş Yılmaz, Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

Necmettin Erbakan University

Ahmet Sami Güven, Professor

Role: STUDY_DIRECTOR

Necmettin Erbakan University

Locations

Nezahat Keleşoğlu Faculty of Health Sciences

Konya, Meram, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

NEU-PT2025-01

Identifier Type: -

Identifier Source: org_study_id