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Cerebral Palsy (CP)NCT06147765

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

An observational study of Cerebral Palsy (CP), run by Hacettepe University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 3 to 6 years
Conditions the study is for
Cerebral Palsy (CP)
How many people
75 participants
Where
No sites listed yet
Study dates
10 Dec 2023to 15 May 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Preschool children with CP

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Melike Tanış contact

+905070720602

meliketanis@hacettepe.edu.tr

About this study

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

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.

Read more

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.

Read the 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.

Keywords
Cerebral palsy, Physical activity, Social skills, Parent, Anxiety, attitude, Social participation
Medical subject headings
Cerebral Palsy, Motor Activity, Social Skills, Anxiety Disorders, Behavior

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10 minutes

  2. 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.

    Measured: 10 minutes

  3. 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.

    Measured: at baseline

  4. 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.

    Measured: 15 minutes

  5. 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.

    Measured: 5 minutes

Secondary outcomes (3)

  1. 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.

    Measured: 5 minutes

  2. 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.

    Measured: 5 minutes

  3. 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.

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2023
  2. Study start10 Dec 2023 (estimated)
  3. Primary completion15 Mar 2024 (estimated)
  4. Study completion15 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06147765
Sponsor's protocol ID
HacettepeU, MTanis
Status last verified
Nov 2023
First submitted
15 Nov 2023
Last updated
28 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23346889

  • 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.

    PubMed 18215191

  • 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.

    PubMed 17654002

  • 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.

    PubMed 16780622

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy (CP), run by Hacettepe University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Melike Tanış (+905070720602, meliketanis@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gross Motor Function Measurement (time frame: 10 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06147765, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.

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