- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04588766
Chronic Constipation With Cerebral Palsy
Evaluation of Posture, Sleep, Physical Activity and Quality of Life in Individuals With Chronic Constipation With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
General motor impairment levels with "Gross Motor Function Classification System, motor functions with "Gross Motor Function Measurement, functional independence levels Functional Independence Measurement, spasticity Modified Ashworth Scale , posture characteristics Spinal Aligment and Range of Motion Measurement, with stool characteristics Bristol Stool Form Scale the presence and severity of constipation with the Modified Constipation Assessment Scale and Constipation Severity Scale sleep quality with Pediatric Sleep Questionnaire physical activity level Physical Activity Scale and life quality was evaluated with Pediatric Quality of Life Inventory .
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Şeyma Nur Önal
- Phone Number: +903782235208
- Email: seymanurelskma@gmail.com
Study Locations
-
-
-
Bartın, Turkey
- Recruiting
- Bartın University
-
Contact:
- Şeyma nur Önal
- Phone Number: +903782235208
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Volunteering to participate in research
- Being between the ages of 2-18
- Being diagnosed with Cerebral Palsy
Exclusion Criteria:
- • 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bristol poop scale
Time Frame: 5 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gross motor function criterion
Time Frame: 20 minutes
|
The Gross Motor Function Scale-88 was created to evaluate the changes in gross motor functions as growth and development continues in individuals with cerebral palsy.
It is a standardized, regular, systematic observational test.
It has categories that follow each other during normal motor and physiological development.
These; are supine, prone, crawling, sitting, laptop, standing, walking, and use of stairs.
These categories include activities appropriate to the headings in the sub-items.
Scoring is divided into five main categories.
It consists of a total of 88 items, 17 in the supine and prone categories, 20 in the sitting category, 14 in the crawling and laptop category, 13 in the standing category, and 24 in the walking, running and stair climbing categories.
While these items are tested, gross motor functions are evaluated according to the correct achievement level.
|
20 minutes
|
The Gross Motor Function Classification System
Time Frame: 2 minutes
|
The Gross Motor Function Classification System was used to classify the gross motor function levels of individuals with CP.
This system is a standard classification system developed by Robert Palisano.
KMFSS is based on actively initiated movements by the individual, focusing on sitting, position change and mobility.
In this five-level system, it is important that the differences between levels are evident in life activities.
The differences are determined by the limitations in functional activities, the need for manual movement aids (walkers, canes, crutches, etc.) or wheeled transport vehicles.
The quality of the movement is of little importance
|
2 minutes
|
Rome IV criteria
Time Frame: 5
|
Constipation is not a disease but a symptom.
Constipation is determined according to Rome IV criteria.
Symptoms should have started at least 6 months ago.
At least 25% of the defecations; in the form of lumpy or hard stools, straining, feeling of anorectal obstruction, feeling of incomplete emptying, using hand aid (finger emptying effort, pelvic floor support); The frequency of defecation should include two or more of the findings of defecation less than 3 times a week, soft stools if laxative is not used, very rare, and not having sufficient criteria for the diagnosis of inflammatory bowel syndrome.
The identified complaints must continue for at least 3 months.
|
5
|
Modified constipation assessment scale
Time Frame: 5 minutes
|
This scale, which will be used to evaluate constipation in individuals, was used in 1989 in McMillan SC. et al.
It is a valid and reliable scale consisting of 9 questions that can be answered by the individual about the presence and severity of constipation and can be used in children and adults.
It contains eight items, each classified as "no problem" by the patient.
It is scored as 'no problem' (0 point), 'some problem' (1 point) or 'serious problem' (2 points).
The item scores are then added up and the total score ranges from 0 (no constipation) to 18 (worst possible constipation).
|
5 minutes
|
Constipation severity scale
Time Frame: 5 minutes
|
To measure the severity of constipation, Varma MG. et al. developed by.
CSO is a scale that questions the frequency and intensity of defecation of individuals and the difficulty in this process.
This scale, which can provide information about constipation symptoms, consists of 16 questions.
|
5 minutes
|
Six-sided pain scale-6
Time Frame: 2 minutes
|
The Hexagonal Pain Scale (YAS-6) was originally developed for use in pediatrics.
There are several versions of YAS, some of them six, seven or nine hundred.
At the same time, the scale with eleven faces is used in current studies to be compatible with the 0--10 Numeric Rating Scale.
|
2 minutes
|
Beverage consumption frequency form
Time Frame: 10 minutes
|
Turkish validity for measuring the daily fluid intake in individuals Eda Köksal et al.
Beverage Consumption Frequency Form prepared by The Beverage Consumption Frequency Form was adapted from Hedrick and the latest version was created with the most and most frequently consumed beverages in Turkish society.
|
10 minutes
|
Sleep form in children
Time Frame: 5 minutes
|
This form, prepared to evaluate the sleep conditions of children, was used by Ronald Chervin et al. to assess sleep-related problems in children aged 2-18 years
|
5 minutes
|
Physical activity scale
Time Frame: 10 minutes
|
The Physical Activity Scale of Preschool Children Dwyer et al.
It is a 3-day activity scale developed by
|
10 minutes
|
Spinal straightness and normal joint motion
Time Frame: 5 minutes
|
Validity in the evaluation of spinal smoothness and general joint mobility in cases Chen, C.L. et al.
The Spinal Alignment and Range of Motion Measure (SAROMM) scale made by
|
5 minutes
|
Quality of life scale for children
Time Frame: 5 minutes
|
The Children's Quality of Life Scale (PedsQL) was used by Varni et al.
To measure the health-related quality of life of individuals aged between 2 and 18 years.
|
5 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- constipationandcerebralpalsy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
-
Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
-
St Mary's University CollegeUniversity of GloucestershireUnknownCerebral Palsy | Cerebral Palsy Ataxic | Cerebral Palsy, MixedUnited Kingdom
-
Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
-
University of California, San FranciscoNational Institutes of Health (NIH)RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey
Clinical Trials on constipation group
-
Walter Reed National Military Medical CenterCompletedFunctional ConstipationUnited States
-
Rigshospitalet, DenmarkInstitute of public health, department of nursing sciences, Århus University...CompletedPostoperative ConstipationDenmark
-
Nemours Children's ClinicCompleted
-
William E. Bennett, Jr.National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University Hospital, BordeauxCompleted
-
Asia UniversityCompleted
-
Texas Tech University Health Sciences CenterNational Center for Complementary and Integrative Health (NCCIH)Completed
-
University of TennesseeNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...RecruitingConstipation | Chronic Kidney DiseaseUnited States
-
Children's Hospital Los AngelesActive, not recruitingGastrointestinal Diseases | Constipation | Autistic DisorderUnited States
-
Mayo ClinicCompletedConstipation Aggravated | Pelvic Floor; IncompetencyUnited States