Cerebral PalsyNCT07466914
Constipation in Children With Cerebral Palsy
An observational study of Cerebral Palsy and Constipation, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy, Constipation, Physical Activity
- What is being tested?
- Observational assessment
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Lokman Hekim University, Ankara, Ankara
Ankara, Ankara, 6510
About this study
Official title: Investigation of Factors Associated With the Presence and Severity of 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.
- Conditions
- Cerebral Palsy, Constipation, Physical Activity
- Being tested
- Observational assessment
- Medical subject headings
- Cerebral Palsy, Constipation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational assessmentOther
Participants completed assessment forms and diaries. No intervention was administered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Observational assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline assessment
Secondary outcomes (6)
Physical activity level
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.
Measured: Baseline assessment
Dietary intake and fiber consumption
Dietary intake, macronutrients, fiber intake, and fluid consumption will be evaluated using a 3-day food consumption diary analyzed with nutrition software.
Measured: Baseline assessment
Functional level
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.
Measured: Baseline assessment
Body mass index
Body mass index will be calculated using height and weight measurements recorded during the assessment.
Measured: Baseline assessment
Caregiver psychological status
Caregiver depression, anxiety, and stress levels will be evaluated using the Depression Anxiety Stress Scale-21 (DASS-21).
Measured: Baseline assessment
Bowel habits
Bowel frequency, stool type, pain during defecation, and fecal incontinence will be recorded using a 7-day bowel diary and Bristol Stool Scale.
Measured: Baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Demet Öztürk, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466914
- Sponsor's protocol ID
- 2026-X
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Factors Associated With the Presence and Severity of Constipation in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07466914
- Acronym / sponsor ID
- 2026-X
- Conditions
- Cerebral Palsy, Constipation, Physical Activity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebral Palsy with Constipation | – | Other: Observational assessmentChildren with cerebral palsy aged 4-18 years who meet Rome IV criteria for constipation and whose caregivers provide informed consent. |
| Cerebral Palsy without Constipation | – | Other: Observational assessmentChildren with cerebral palsy aged 4-18 years who do not meet Rome IV criteria for constipation and whose caregivers provide informed consent. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational assessmentParticipants completed assessment forms and diaries. No intervention was administered. | Other | Cerebral Palsy with Constipation, Cerebral Palsy without Constipation |
Primary outcome
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.
6 secondary outcomes
Physical activity level
Time frame: Baseline assessment
Dietary intake and fiber consumption
Time frame: Baseline assessment
Functional level
Time frame: Baseline assessment
Body mass index
Time frame: Baseline assessment
Caregiver psychological status
Time frame: Baseline assessment
Bowel habits
Time frame: Baseline assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Constipation, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation Severity (time frame: Baseline assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.