The Effect of Occupational Therapy Home Programs on Sensory Processing and Feeding Problems in Children With Down Syndrome: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Sensory Profile
研究概览
简要总结
Children with Down Syndrome frequently encounter difficulties with sensory functions and feeding, such as oral sensory processing issues and developmental disorders. The aim of this study was to examine the effects of an Occupational Therapy Home Program on the sensory functions and feeding issues of children with Down Syndrome.
详细描述
Although there are studies that investigate nutritional issues in children with Down syndrome, no well-structured, high-evidence, and individual-centered studies have been found. The literature assumes a relationship between the sensory functions and nutritional status of children with Down syndrome. Therefore, further studies are needed to develop intervention programs to prevent sensory processing and nutritional problems.
This study aims to evaluate the effectiveness of occupational therapy home programs in improving sensory functions and feeding problems in children with Down syndrome. The study focuses on evidence-based practices to assess the impact of these programs compared to not providing them.
The study will be conducted with children diagnosed with Down Syndrome who have applied to the Pediatrics Unit of the Department of Occupational Therapy at Hacettepe University Faculty of Health Sciences.
The study comprises pre-evaluation, final evaluation, and intervention stages. Following the initial evaluation, an occupational therapy home intervention program will be implemented for the children before and after each meal, seven days a week, for eight weeks. Evaluations will be repeated after the eight-week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be between the ages of 3-10
- •Having Down Syndrome
- •Families agree to participate in the study
排除标准
- •Having previously received sensory integration and/or occupational therapy treatment
- •Having a secondary diagnosis other than Down Syndrome (Mental Retardation, etc.)
研究组 & 干预措施
OTHP Group (Intervention Group)
Children with Down syndrome will undergo an 8-week occupational therapy home program (OTHP). Evaluations will be conducted at the beginning and end of the intervention, and the results will be compared.
干预措施: Occupational therapy home program (Other)
None OTHP Group (Control group)
The control group (non-OTHP) will not receive occupational therapy home program, even if they have Down syndrome. Evaluations will be conducted at 8-week intervals, with the first and last evaluations being compared.
结局指标
主要结局
Sensory Profile
时间窗: 8 weeks
The Sensory Profile developed by Winnie Dunn was used to evaluate sensory processing skills in Turkish. This assessment is suitable for children aged three to ten. The test is completed by an occupational therapist, accompanied by the person who has the most contact with the child in their daily life. Each item is scored on a Likert scale from 1 to 5. The Sensory Profile consists of three parts: sensory processing, modulation, and behavioral-emotional responses. Each part has 14 parameters. The score indicates the level of sensitivity, with lower scores indicating hypersensitivity, higher scores indicating hyposensitivity, and middle values indicating typical performance.
Screen Tool of Feeding Problems (STEP)
时间窗: 8 weeks
The study used the Systematic Tool for Evaluating Progress (STEP) to identify feeding challenges and problematic feeding behaviours experienced by individuals with Down Syndrome (DS). STEP includes questions for parents or personnel who have worked with the individual for the last six months, asking about any abnormal behaviours observed in the last month. The survey consists of 23 items, each addressing a specific nutritional issue. The aforementioned issues are categorized into five subgroups: aspiration risk, food selectivity, feeding skills, behavioural problems related to food rejection, and behavioural problems related to nutrition. The study used the Systematic Tool for Evaluating Progress (STEP) to identify feeding challenges and problematic feeding behaviours experienced by individuals with Down Syndrome (DS). An increase in the score suggests an increase in nutritional problems.
Demographic Form
时间窗: 8 weeks
The form completed by the child's primary caregiver includes information such as the child's age, gender, number of siblings, and the marital status of both parents.
A meal time
时间窗: 8 weeks
The study recorded the child's average meal time as reported by their parents during the first and last evaluations. The event was documented in the minutes.
次要结局
未报告次要终点