NCT07209800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
Last Updated

October 7, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

September 29, 2025

Last Update Submit

September 29, 2025

Conditions

Keywords

Chewing disorder, Karaduman Chewing Performance Scale (KCPS), Oral awareness, Pediatric rehabilitation, Sensory integration therapy.

Outcome Measures

Primary Outcomes (3)

  • Chewing performance:

    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

    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:

    Age, sex, height, weight, and diagnosis.

    Before the start of the therapy.

Study Arms (1)

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.

Other: Sensory integration therapy

Interventions

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

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nezahat Keleşoğlu Faculty of Health Sciences

Konya, Meram, 40336, Turkey (Türkiye)

Location

Study Officials

  • Neslihan Altuntaş Yılmaz, Assistant Professor

    Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR
  • Ahmet Sami Güven, Professor

    Necmettin Erbakan University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The outcomes assessor was blinded; the researcher administering the intervention was not involved in the assessments
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PhD

Study Record Dates

First Submitted

September 29, 2025

First Posted

October 7, 2025

Study Start

December 1, 2023

Primary Completion

November 1, 2024

Study Completion

February 1, 2025

Last Updated

October 7, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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

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