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NCT Number: NCT07466914

Constipation in Children With Cerebral Palsy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cerebral Palsy Behavior Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Constipation Motor Activity Nervous System Diseases Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms Signs and Symptoms, Digestive

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lokman Hekim University, Ankara, Ankara

Ankara, 6510, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational Assessment

Other

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

Primary outcomes

  1. 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.

  2. 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

  1. Physical activity level

    Time frame: Baseline assessment

    Physical 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.

  2. Dietary intake and fiber consumption

    Time frame: Baseline assessment

    Dietary intake, macronutrients, fiber intake, and fluid consumption will be evaluated using a 3-day food consumption diary analyzed with nutrition software.

  3. Functional level

    Time frame: Baseline assessment

    Functional level will be assessed using the Gross Motor Function Classification System (GMFCS), which classifies motor function in children with cerebral palsy into five levels.

  4. Body mass index

    Time frame: Baseline assessment

    Body mass index will be calculated using height and weight measurements recorded during the assessment.

  5. Caregiver psychological status

    Time frame: Baseline assessment

    Caregiver depression, anxiety, and stress levels will be evaluated using the Depression Anxiety Stress Scale-21 (DASS-21).

  6. Bowel habits

    Time frame: Baseline assessment

    Bowel frequency, stool type, pain during defecation, and fecal incontinence will be recorded using a 7-day bowel diary and Bristol Stool Scale.

Sponsors and collaborators

Lead sponsor

Lokman Hekim University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Mar 12, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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