NCT07466914

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
21mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Mar 2026Mar 2028

Study Start

First participant enrolled

March 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Expected
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

March 9, 2026

Last Update Submit

March 12, 2026

Conditions

Cerebral PalsyConstipationPhysical Activity

Outcome Measures

Primary Outcomes (2)

  • Constipation Severity

    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.

    Baseline assessment

  • Presence of constipation

    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.

    Baseline assessment

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

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.

Other: Observational assessment

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.

Other: Observational assessment

Interventions

Observational assessmentOTHER

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

Cerebral Palsy with ConstipationCerebral Palsy without Constipation

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with cerebral palsy aged 4-18 years and their caregivers who are followed at rehabilitation centers will be included. Both children with constipation and without constipation will be enrolled.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lokman Hekim University, Ankara, Ankara

Ankara, Ankara, 6510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyConstipationMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 12, 2026

Study Start

March 1, 2026

Primary Completion

April 1, 2026

Study Completion (Estimated)

March 1, 2028

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations

TU(1)