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

November 22, 2023 updated by: Melike Tanis, Hacettepe University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Preschool children with CP

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Motor Function Measurement
Time Frame: 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.
10 minutes
Quality of Upper Extremity Skills Test
Time Frame: 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.
10 minutes
Bouchard Three-Day Physical Activity Record
Time Frame: 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.
at baseline
Pediatric Evaluation of Disability Inventory
Time Frame: 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.
15 minutes
Child and Adolescent Scale Of Participation (CASP)
Time Frame: 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.
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental Attitude Scale
Time Frame: 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.
5 minutes
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 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.
5 minutes
Preschool and Kindergarten Behavior Scales
Time Frame: 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.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Nezire Köse, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 10, 2023

Primary Completion (Estimated)

March 15, 2024

Study Completion (Estimated)

May 15, 2024

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

November 22, 2023

First Posted (Actual)

November 28, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HacettepeU, MTanis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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