Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chronic Constipation With Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04588766
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Şeyma Nur Önal, Bartın Unıversity

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

Condition or disease Intervention/treatment
Cerebral Palsy Other: constipation group Other: control group

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 .

Layout table for study information
Study Type : Observational
Estimated Enrollment : 81 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Posture, Sleep, Physical Activity and Quality of Life in Individuals With Chronic Constipation With Cerebral Palsy
Estimated Study Start Date : October 15, 2020
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine


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.
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.
Other: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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. 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

  11. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04588766


Contacts
Layout table for location contacts
Contact: Şeyma Nur Önal +903782235208 seymanurelskma@gmail.com

Locations
Layout table for location information
Turkey
Bartın University Recruiting
Bartın, Turkey
Contact: Şeyma nur Önal    +903782235208      
Sponsors and Collaborators
Bartın Unıversity
Layout table for additonal information
Responsible Party: Şeyma Nur Önal, Lecturer, Bartın Unıversity
ClinicalTrials.gov Identifier: NCT04588766    
Other Study ID Numbers: constipationandcerebralpalsy
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Şeyma Nur Önal, Bartın Unıversity:
Cerebral palsy
Constipation
Physical activity
Posture
Quality of life
Sleep
Additional relevant MeSH terms:
Layout table for MeSH terms
Paralysis
Cerebral Palsy
Constipation
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Signs and Symptoms, Digestive