NCT06147765

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

December 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

November 15, 2023

Last Update Submit

November 22, 2023

Conditions

Keywords

Cerebral palsyPhysical activitySocial skillsParentAnxietyattitudeSocial participation

Outcome Measures

Primary Outcomes (5)

  • 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

  • Quality of Upper Extremity Skills Test

    ıt 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

  • Bouchard Three-Day Physical Activity Record

    ıt was used to measure daily energy expenditure in children and adolescents.ıt questions the activities that the children in two days during the week and one day on the weekend.

    at baseline

  • 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

  • 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 Outcomes (3)

  • Parental Attitude Scale

    5 minutes

  • Hospital Anxiety and Depression Scale (HADS)

    5 minutes

  • Preschool and Kindergarten Behavior Scales

    5 minutes

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Preschool children with CP

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 23346889BACKGROUND
  • 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.

    PMID: 18215191BACKGROUND
  • 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.

    PMID: 17654002BACKGROUND
  • 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.

    PMID: 16780622BACKGROUND

Related Links

MeSH Terms

Conditions

Cerebral PalsyMotor ActivitySocial SkillsAnxiety DisordersBehavior

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSocial BehaviorMental Disorders

Study Officials

  • Nezire Köse

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MELİKE TANIŞ

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 28, 2023

Study Start

December 10, 2023

Primary Completion

March 15, 2024

Study Completion

May 15, 2024

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share