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Constipation in Children With Cerebral Palsy

Investigation of Factors Associated With the Presence and Severity of Constipation in Children With Cerebral Palsy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07466914
Enrollment
100
Registered
2026-03-12
Start date
2026-03-01
Completion date
2028-03-01
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Constipation, Physical Activity

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.

Interventions

OTHERObservational assessment

Participants completed assessment forms and diaries. No intervention was administered.

Sponsors

Lokman Hekim University
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Constipation SeverityBaseline assessmentThe 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 constipationBaseline assessmentConstipation 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

MeasureTime frameDescription
Physical activity levelBaseline assessmentPhysical activity level will be evaluated using a 24-hour physical activity diary recorded for three days. Activity intensity will be calculated using metabolic equivalent (MET) values.
Dietary intake and fiber consumptionBaseline assessmentDietary intake, macronutrients, fiber intake, and fluid consumption will be evaluated using a 3-day food consumption diary analyzed with nutrition software.
Functional levelBaseline assessmentFunctional level will be assessed using the Gross Motor Function Classification System (GMFCS), which classifies motor function in children with cerebral palsy into five levels.
Body mass indexBaseline assessmentBody mass index will be calculated using height and weight measurements recorded during the assessment.
Caregiver psychological statusBaseline assessmentCaregiver depression, anxiety, and stress levels will be evaluated using the Depression Anxiety Stress Scale-21 (DASS-21).
Bowel habitsBaseline assessmentBowel frequency, stool type, pain during defecation, and fecal incontinence will be recorded using a 7-day bowel diary and Bristol Stool Scale.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026