Cerebral PalsyNCT04588766
Chronic Constipation With Cerebral Palsy
An observational study of Cerebral Palsy, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial summary
This study was performed to evaluate posture, sleep, physical activity and quality of life in individuals with chronic constipation Cerebral Palsy. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- constipation group
- Type of treatment
- Injection or infusion
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2020to 15 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Volunteering to participate in research
- Being between the ages of 2-18
- Being diagnosed with Cerebral Palsy
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bartın University
Bartın
Şeyma nur Önal, +903782235208
About this study
Official title: Evaluation of Posture, Sleep, Physical Activity and Quality of Life in Individuals With Chronic Constipation With Cerebral Palsy
This study was performed to evaluate posture, sleep, physical activity and quality of life in individuals with chronic constipation Cerebral Palsy.
Read the 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 .
- Conditions
- Cerebral Palsy
- Being tested
- constipation group, control group
- Keywords
- Cerebral palsy, Constipation, Physical activity, Posture, Quality of life, Sleep
- 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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Secondary outcomes (11)
Gross motor function criterion
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.
Measured: 20 minutes
The Gross Motor Function Classification System
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
Measured: 2 minutes
Rome IV criteria
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.
Measured: 5
Modified constipation assessment scale
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).
Measured: 5 minutes
Constipation severity scale
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.
Measured: 5 minutes
Six-sided pain scale-6
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.
Measured: 2 minutes
Beverage consumption frequency form
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.
Measured: 10 minutes
Sleep form in children
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
Measured: 5 minutes
Physical activity scale
The Physical Activity Scale of Preschool Children Dwyer et al. It is a 3-day activity scale developed by
Measured: 10 minutes
Spinal straightness and normal joint motion
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
Measured: 5 minutes
Quality of life scale for children
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start15 Oct 2020 (estimated)
- Primary completion15 Dec 2020 (estimated)
- Study completion15 Jan 2021 (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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyma Nur Önal, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588766
- Sponsor's protocol ID
- constipationandcerebralpalsy
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Posture, Sleep, Physical Activity and Quality of Life in Individuals With Chronic Constipation With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04588766
- Acronym / sponsor ID
- constipationandcerebralpalsy
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Constipation, Physical activity, Posture, Quality of life, Sleep
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 15 Jan 2021 (estimated)
- First posted
- 19 Oct 2020 (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.
This study was performed to evaluate posture, sleep, physical activity and quality of life in individuals with chronic constipation Cerebral Palsy.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| constipation group | – | Other: constipation groupConstipation 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 | – | Other: control groupConstipation 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Volunteering to participate in research
- Being between the ages of 2-18
- Being diagnosed with Cerebral Palsy
Key exclusion criteria (4 listed)
- • 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
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 |
|---|---|---|
| constipation groupConstipation 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 groupConstipation 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 |
Primary outcome
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.
11 secondary outcomes
Gross motor function criterion
Time frame: 20 minutes
The Gross Motor Function Classification System
Time frame: 2 minutes
Rome IV criteria
Time frame: 5
Modified constipation assessment scale
Time frame: 5 minutes
Constipation severity scale
Time frame: 5 minutes
Six-sided pain scale-6
Time frame: 2 minutes
Beverage consumption frequency form
Time frame: 10 minutes
Sleep form in children
Time frame: 5 minutes
Physical activity scale
Time frame: 10 minutes
Spinal straightness and normal joint motion
Time frame: 5 minutes
Quality of life scale for children
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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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.
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, run by Bartın Unıversity 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Şeyma Nur Önal (+903782235208, seymanurelskma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bristol poop scale (time frame: 5 minutes). 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 19 Oct 2020.