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

Sponsor
Hacettepe University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06147765
Collaborator
(none)
75
5.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    75 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    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
    Anticipated Study Start Date :
    Dec 10, 2023
    Anticipated Primary Completion Date :
    Mar 15, 2024
    Anticipated Study Completion Date :
    May 15, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Gross Motor Function Measurement [10 minutes]

      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.

    2. Quality of Upper Extremity Skills Test [10 minutes]

      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.

    3. Bouchard Three-Day Physical Activity Record [at baseline]

      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.

    4. Pediatric Evaluation of Disability Inventory [15 minutes]

      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.

    5. Child and Adolescent Scale Of Participation (CASP) [5 minutes]

      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.

    Secondary Outcome Measures

    1. Parental Attitude Scale [5 minutes]

      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.

    2. Hospital Anxiety and Depression Scale (HADS) [5 minutes]

      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.

    3. Preschool and Kindergarten Behavior Scales [5 minutes]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hacettepe University

    Investigators

    • Principal Investigator: Nezire Köse, Hacettepe University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Melike Tanis, MELİKE TANIŞ, Hacettepe University
    ClinicalTrials.gov Identifier:
    NCT06147765
    Other Study ID Numbers:
    • HacettepeU, MTanis
    First Posted:
    Nov 28, 2023
    Last Update Posted:
    Nov 28, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Melike Tanis, MELİKE TANIŞ, Hacettepe University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 28, 2023