NCT04588766

Brief Summary

This study was performed to evaluate posture, sleep, physical activity and quality of life in individuals with chronic constipation Cerebral Palsy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 9, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

October 9, 2020

Last Update Submit

October 9, 2020

Conditions

Cerebral Palsy

Keywords

Cerebral palsyConstipationPhysical activityPostureQuality of lifeSleep

Outcome Measures

Primary Outcomes (1)

  • Bristol poop scale

    The Bristol Poop Scale is a 7-point scale and was used to define stool consistency. It has been shown that the Bristol Poop Scale is associated with constipation and colonic transit time in children without constipation (140). Hard stools fit 1 and 2, loose (ideal) stools fit 3, 4, 5, diarrhea types 6 and 7. Therefore, represented by stool consistency scores as hard, loose stools and diarrhea.

    5 minutes

Secondary Outcomes (11)

  • Gross motor function criterion

    20 minutes

  • The Gross Motor Function Classification System

    2 minutes

  • Rome IV criteria

    5

  • Modified constipation assessment scale

    5 minutes

  • Constipation severity scale

    5 minutes

  • +6 more secondary outcomes

Study Arms (2)

constipation group

Constipation symptoms of individuals with cerebral palsy who were randomly evaluated were questioned and recorded according to Rome IV criteria. The group with cerebral palsy constipation was included in this group.

Other: constipation group

control group

Constipation symptoms of individuals with cerebral palsy who were evaluated randomly were questioned and recorded according to Rome IV criteria. The group with cerebral palsy without constipation was included in this group.

Other: control group

Interventions

constipation groupOTHER

Constipation symptoms of individuals with cerebral palsy who were randomly evaluated were questioned and recorded according to Rome IV criteria. The group with cerebral palsy constipation was included in this group.

constipation group
control groupOTHER

Constipation symptoms of individuals with cerebral palsy who were evaluated randomly were questioned and recorded according to Rome IV criteria. The group with cerebral palsy without constipation was included in this group.

control group

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The study included 81 individuals diagnosed with CP, 3-18 years of age and 2 groups with and without constipation according to Rome IV criteria.

You may qualify if:

  • Volunteering to participate in research
  • Being between the ages of 2-18
  • Being diagnosed with Cerebral Palsy

You may not qualify if:

  • Having undergone surgery involving intestinal health
  • Having a chronic infectious bowel disease
  • Having a congenital bowel anomaly
  • Having received botox treatment in the last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartın University

Bartın, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral PalsyConstipationMotor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Şeyma Nur Önal

CONTACT

+903782235208seymanurelskma@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 19, 2020

Study Start

October 15, 2020

Primary Completion

December 15, 2020

Study Completion

January 15, 2021

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

TU(1)