Relations Between Activity, Participation and Social Skills Levels of Preschool Cerebral Palsy and Parental Attitudes

Cerebral Palsy (CP) Clinical Trial

Official title:

İnvestigation of the Relations Between Activity and Participation Levels, Social Skills and Behavior Levels of Children With Cerebral Palsy in Preschool Period and Parental Attitudes and Anxiety Levels

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06147765
• Other study ID #: HacettepeU, MTanis
• Status: Not yet recruiting
• Start date: December 10, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: November 2023
• Source: Hacettepe University
• Contact: Melike Tanis
• Phone: +905070720602
• Email: meliketanis[@]hacettepe.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cerebral palsy (CP) is a chronic condition which affects the development of motor function and posture, occurs as a result of injury or malformation in the developing central nervous system before, during or immediately after birth. Depending on the health conditions accompanying motor and sensory problems of children with CP in the pre-school period, they are insufficient to be active in their daily lives, to play games, to spend time with their peers and to perform self-care activities. In addition to care difficulties, economic difficulties, problems in reaching rehabilitation centers, many problems such as fear of their children's future, falling behind their peers, and who will take care of their children after them cause anxiety and stress for families. We can foresee that parenting attitudes may change in line with the anxiety and stress created by all these difficulties. The investigator planned to do this study because we found that there is a need for studies examining the effects of the attitudes and anxiety levels of families of children with CP on children's activity and participation and social skills.

Description:

in our study, the relationship between the attitudes and anxiety levels of parents with children with CP and the activity and participation levels of children will be examined. at the same time, it will be investigated whether there is a relationship between children's social skills and behaviors and physical activity and participation levels. Eligibity Criteria: cerebral palsy diagnosed 3-6 years Children or family who understand and speek Turkish language Children or family who know writing and reading Volunteer to join the study Going to pre-school education and/or special education and rehabilitation center for at least 3 months Outcome Measures Clinical classifications: Gross Motor Function Classification System for classifying gross motor function levels Manuel ability classification system for classifying fine motor function levels Communication Function Classification System for classifying communication function levels Eating Drinking Abilities Classification System for classifying eating and drinking functions levels will be used Physical Activity and Participation: Gross Motor Function Measurement, Quality of Upper Extremity Skills Test, Bouchard Three-Day Physical Activity Record , Pediatric Evaluation of Disability Inventory, Child and Adolescent Scale of Participation will be used Parental and Social Environment: Parental Attitude Scale, Hospital Anxiety and Depression Scale, Preschool and Kindergarten Behavior Scale will be used.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: May 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

Inclusion Criteria:

• having been diagnosed with CP
• between the ages of 3-6
• parents/caregivers and those who speak Turkish
• their parents/caregivers are literate
• going to pre-school education and/or special education and rehabilitation center for at least 3 months
• those who agreed to participate in the study

Exclusion Criteria:

• different additional congenital and hereditary different disease that give system to CP
• children who have undergone any surgical procedure in the last 1 year

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy (CP)
• Paralysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

References & Publications (4)

Eliasson AC, Krumlinde-Sundholm L, Rosblad B, Beckung E, Arner M, Ohrvall AM, Rosenbaum P. The Manual Ability Classification System (MACS) for children with cerebral palsy: scale development and evidence of validity and reliability. Dev Med Child Neurol. 2006 Jul;48(7):549-54. doi: 10.1017/S0012162206001162. — View Citation

Erkin G, Elhan AH, Aybay C, Sirzai H, Ozel S. Validity and reliability of the Turkish translation of the Pediatric Evaluation of Disability Inventory (PEDI). Disabil Rehabil. 2007 Aug 30;29(16):1271-9. doi: 10.1080/09638280600964307. — View Citation

Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24. Erratum In: Dev Med Child Neurol. 2016 Mar;58(3):316. — View Citation

Shelly A, Davis E, Waters E, Mackinnon A, Reddihough D, Boyd R, Reid S, Graham HK. The relationship between quality of life and functioning for children with cerebral palsy. Dev Med Child Neurol. 2008 Mar;50(3):199-203. doi: 10.1111/j.1469-8749.2008.02031.x. Epub 2008 Jan 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross Motor Function Measurement	Children's motor ability will be assessed to investigate the correlations between the motor functions and orthosis used by child. The GMFM-88 consists of 88 items examining children's gross motor movements. Each item is scored between 0 and 3 points. The higher the child gets, the more successful the child is in gross motor functions.	10 minutes
Primary	Quality of Upper Extremity Skills Test	it was used to assess the function and quality of upper limb movements. This test has a total of 7 subdivisions, and the scoring of each section is calculated using a standardized formula. Each chapter is scored between 0-100 within itself. The first four section scores are used to calculate the total score. A high score indicates better the quality of the movement.	10 minutes
Primary	Bouchard Three-Day Physical Activity Record	it was used to measure daily energy expenditure in children and adolescents.it questions the activities that the children in two days during the week and one day on the weekend.	at baseline
Primary	Pediatric Evaluation of Disability Inventory	It is a scale that evaluates the functional skills of the child and the help and manner of the caregiver, in which each part is evaluated separately as self-care, mobility and social function items.	15 minutes
Primary	Child and Adolescent Scale Of Participation (CASP)	Participation measurement The CASP consists of 20 ordinal-scaled items and four subsections: 1) Home Participation 2) Community Participation 3) School Participation and 4) Home and Community Living Activities The 20 items are rated on a four-point scale: Age Expected (Full participation) to Unable.	5 minutes
Secondary	Parental Attitude Scale	for measuring the child-rearing behaviors of the parents. This Likert-type scale was composed of four subscales including "Democratic", "Authoritarian", "Permissive" and "Protective"; and consisted of 46 items.	5 minutes
Secondary	Hospital Anxiety and Depression Scale (HADS)	the scale is determining the levels of anxiety and depression that a person is experiencing.The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression.	5 minutes
Secondary	Preschool and Kindergarten Behavior Scales	the scale is a norm-referenced , standardized behavior rating scale designed to assess problem behaviors and social skills of children from ages 3 through 6 years.	5 minutes

External Links

•   Dammann O. Evidence-based child neurology. Dev Med Child Neurol. 2006 Jul;48(7):622-4. doi: 10.1017/S0012162206001307. PMID: 16780636.
•   Erkin G, Elhan AH, Aybay C, Sirzai H, Ozel S. Validity and reliability of the Turkish translation of the Pediatric Evaluation of Disability Inventory (PEDI). Disabil Rehabil. 2007 Aug 30;29(16):1271-9.
•   The relationship between quality of life and functioning for children with cerebral palsy.