Investigation of Factors Associated With the Presence and Severity of Constipation in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Constipation Severity
研究概览
简要总结
Constipation is a common problem in children with cerebral palsy and may negatively affect daily activities, quality of life, and family well-being. Several factors such as nutrition, physical activity level, functional status, and psychological condition of the caregiver may be associated with constipation in this population.
The aim of this study is to investigate the presence and severity of constipation in children with cerebral palsy and to examine the factors that may be related to constipation, including dietary intake, fluid consumption, physical activity level, functional status, and caregiver psychological status.
This study is an observational cross-sectional study including children with cerebral palsy aged 4-18 years and their caregivers. Data will be collected using questionnaires, clinical classification systems, bowel diaries, nutrition records, and psychological scales. No intervention will be applied to participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cerebral palsy
- •Age between 4 and 18 years
- •Voluntary participation with signed informed consent from the child or caregiver
- •For constipation group: meeting Rome IV criteria for constipation for at least 3 months
- •For non-constipation group: not meeting Rome IV criteria for constipation
排除标准
- •History of gastrointestinal or anorectal surgery
- •Presence of anorectal malformation
- •Severe scoliosis (>45 degrees)
- •Any medical condition that may affect bowel function unrelated to cerebral palsy
- •Incomplete questionnaires or missing data
研究组 & 干预措施
Cerebral Palsy without Constipation
Children with cerebral palsy aged 4-18 years who do not meet Rome IV criteria for constipation and whose caregivers provide informed consent.
干预措施: Observational assessment (Other)
Cerebral Palsy with Constipation
Children with cerebral palsy aged 4-18 years who meet Rome IV criteria for constipation and whose caregivers provide informed consent.
干预措施: Observational assessment (Other)
结局指标
主要结局
Constipation Severity
时间窗: Baseline assessment
The Constipation Assessment Scale (CAS) will be used to evaluate the severity of constipation in children with cerebral palsy. The scale consists of 8 items scored from 0 to 2, with higher scores indicating more severe constipation.
Presence of constipation
时间窗: Baseline assessment
Constipation will be determined according to Rome IV diagnostic criteria. Children meeting at least two criteria for at least three months will be classified as having constipation.
次要结局
- Physical activity level(Baseline assessment)
- Dietary intake and fiber consumption(Baseline assessment)
- Functional level(Baseline assessment)
- Body mass index(Baseline assessment)
- Caregiver psychological status(Baseline assessment)
- Bowel habits(Baseline assessment)
研究者
Demet Öztürk
Assist. Prof.
Lokman Hekim University