Investigation of Factors Associated With the Presence and Severity of Constipation in Children With Cerebral Palsy
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Lokman Hekim University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Constipation Severity
Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 4 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: Observational assessment (Other)
Outcomes
Primary Outcomes
Constipation Severity
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Demet Öztürk
Assist. Prof.
Lokman Hekim University