Clinical trial NCT06147765: Relations Between Activity, Participation and Social Skills Levels of Preschool Cerebral Palsy and Parental Attitudes
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cerebral Palsy (CP)
Keywords: Cerebral palsy
Physical activity
Social skills
Parent
Anxiety
attitude
Social participation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 75
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Preschool children with CP

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Gross Motor Function Measurement
timeFrame: 10 minutes
measure: Quality of Upper Extremity Skills Test
timeFrame: 10 minutes
measure: Bouchard Three-Day Physical Activity Record
timeFrame: at baseline
measure: Pediatric Evaluation of Disability Inventory
timeFrame: 15 minutes
measure: Child and Adolescent Scale Of Participation (CASP)
timeFrame: 5 minutes
Secondary outcomes:
measure: Parental Attitude Scale
timeFrame: 5 minutes
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 5 minutes
measure: Preschool and Kindergarten Behavior Scales
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University
name: Nezire Köse
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.