Chronic Constipation With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Evaluation of Posture, Sleep, Physical Activity and Quality of Life in Individuals With Chronic Constipation With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04588766
• Other study ID #: constipationandcerebralpalsy
• Status: Recruiting
• Start date: October 15, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: October 2020
• Source: Bartin University
• Contact: Seyma Nur Önal
• Phone: +903782235208
• Email: seymanurelskma[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: January 15, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Constipation
• Paralysis

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Bartin University	Bartin

Sponsors (1)

Lead Sponsor	Collaborator
Bartin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	20 minutes
Secondary	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	2 minutes
Secondary	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.	5
Secondary	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).	5 minutes
Secondary	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.	5 minutes
Secondary	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.	2 minutes
Secondary	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.	10 minutes
Secondary	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	5 minutes
Secondary	Physical activity scale	The Physical Activity Scale of Preschool Children Dwyer et al. It is a 3-day activity scale developed by	10 minutes
Secondary	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	5 minutes
Secondary	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.	5 minutes