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临床试验/NCT07209800
NCT07209800已完成不适用

Effectiveness of Whole-Body Sensory Integration Therapy on Chewing Function and Feeding Behaviors in Children With Chewing Disorders

Necmettin Erbakan University1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Meal frequency and duration

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

The outcomes assessor was blinded; the researcher administering the intervention was not involved in the assessments

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Sensory integration therapy (Other)

结局指标

主要结局

Meal frequency and duration

时间窗: 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:

时间窗: Before the start of the therapy.

Age, sex, height, weight, and diagnosis.

Chewing performance:

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Neslihan Altuntas Yilmaz

Assistant Professor, PhD

Necmettin Erbakan University

研究点 (1)

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