NCT06944171

Brief Summary

This study will investigate the effects of associated impairments on the activity levels and social participation of school-aged children with Cerebral Palsy (aged 6-12) and their impact on their families' quality of life and caregiving burden.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2025

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

April 17, 2025

Last Update Submit

April 17, 2025

Conditions

Keywords

familycomorbiditychildintellectual disabilitycerebral palsyepilepsyseizuresvision disordershearing lossspeech disorderscaregiverquality of lifeactivities of daily lifesocial participation

Outcome Measures

Primary Outcomes (2)

  • PEDI-CAT (Pediatric Evaluation of Disability Inventory Computer Adaptive Test)

    The PEDI-CAT measures abilities in three functional domains: Daily Activities, Mobility and Social/Cognitive. The PEDI-CAT's Responsibility domain measures the extent to which the caregiver or child takes responsibility for managing complex, multi-step life tasks.

    Single assessment conducted during the initial study visit

  • LIFE-H 3.0 (The Assessment of life habits)

    The Assessment of life habits (LIFE-H) is a questionnaire that is used to collect information on all life habits that people carry out in their environment (home, workplace or school, neighborhood) to ensure their survival and development in society throughout their lifetime. LIFE-H uses a numerical scoring system ranging from 0 to 9. A score of 0 indicates a complete disability or impairment in participation, while a score of 9 indicates an optimal level of participation.

    Single assessment conducted during the initial study visit

Secondary Outcomes (2)

  • Nottingham Health Profile

    Single assessment conducted during the initial study visit

  • Impact on Family Scale (IPFAM)

    Single assessment conducted during the initial study visit

Study Arms (2)

School-aged children with Cerebral Palsy

Children with cerebral palsy between the ages of 6 and 12 volunteered for the study

Families with children with cerebral palsy

Parents of children with cerebral palsy between the ages of 6 and 12 volunteered for the study.

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with CPand their families who applied to Hacettepe University Faculty of Physical Therapy and Rehabilitation Cerebral Palsy and Pediatric Rehabilitation Unit and Ministry of National Education Keçiören Guidance and Research Center and agreed to participate in the study.

You may qualify if:

  • Having a diagnosis of cerebral palsy
  • Being between the ages of 6-12

You may not qualify if:

  • Being under the age of 6 and over the age of 12
  • Parents and children who do not volunteer to participate in the study
  • Not knowing Turkish
  • For families:
  • Having a child between the ages of 6-12 diagnosed with cerebral palsy
  • Not being willing to participate in the study
  • Not knowing Turkish
  • Not being able to read and write

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation Cerebral Palsy and Pediatric Rehabilitation Unit

Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral PalsyIntellectual DisabilityEpilepsySeizuresVision DisordersHearing LossSpeech Disorders

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersSensation DisordersEye DiseasesHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesLanguage DisordersCommunication Disorders

Study Officials

  • Mintaze Kerem-Gunel, Professor

    Hacettepe University, Faculty of Physical Therapy and Rehabilitation

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

April 17, 2025

First Posted

April 25, 2025

Study Start

October 1, 2024

Primary Completion

June 20, 2025

Study Completion

June 27, 2025

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Participants were informed, through the written informed consent form, that all personal data collected during the study would be kept strictly confidential and used solely for research purposes. The form also explained that their identities would not be revealed in any publication or report resulting from the study.

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