Clinical trial NCT06944171: Effects of Associated Impairments on Activity and Participation in Children With Cerebral Palsy
Official title: Investigation of the Effects of Associated Impairments in School-Age Children With Cerebral Palsy on the Child's Activity and Participation Level and on Their Families
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Keywords: family
comorbidity
child
intellectual disability
cerebral palsy
epilepsy
seizures
vision disorders
hearing loss
speech disorders
caregiver
quality of life
activities of daily life
social participation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 107
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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.

Detailed description: Cerebral Palsy (CP) defines a group of permanent disorders in movement and posture development, which are expressed as non-progressive disorders that occur in the developing baby brain during life in the womb or the first 3 years after birth, causing restrictions in activity and participation.

Hearing, speech, vision, cognitive, eating and swallowing problems and epilepsy primarily accompany the motor and postural control problems seen in CP. It is reported that cognitive disabilities or learning difficulties are seen in 50-75%, speech problems in 25%, hearing problems in 25%, seizures in 25-35% and visual disorders in 40-50% of individuals with CP. These primary problems, which accompany from the beginning, vary according to the clinical type and functional effect of CP and affect the severity of the existing CP clinical picture.

The International Classification of Functioning, Disability and Health (ICF) is a framework that guides the comprehensive assessment and treatment of children with CP by considering the wide range of health-related problems they face. The ICF includes four interrelated components: body structure and functions, activity and participation, and personal and environmental factors. According to the ICF, impairments are defined as significant deviations or losses in body structure and functions, while activity limitations, difficulties in activities, and participation restrictions are defined as problems in the form or scope of participation in life.

With these impairments added to the clinical picture, children with CP face significant limitations in their activity and participation levels. Therefore, it is important to define the relationship between comorbid impairments and activity and participation limitations in order to create holistic treatment goals and interventions that improve the activity and participation levels of children with CP.

According to the World Health Organization, quality of life, especially the health-related quality of life of parents of children with special needs, is a complex and comprehensive concept related to the physical health status, psychological status, independence level, social relationships, personal beliefs and environmental characteristics of the parents.

The care of children with CP is long-term and difficult. It has been reported that frequent hospital visits from the moment of diagnosis, the need for multidisciplinary therapy and the difficulty of the care process can lead to the parents not being able to spare time for themselves and their surroundings, economic difficulties and deterioration in their quality of life.

When the literature is examined, no study has been found that examines the multidimensional problems accompanying CP, especially with a sample from our country.

Eligibility criteria: For children:

Inclusion criteria

* Having a diagnosis of cerebral palsy
* Being between the ages of 6-12
* Having family approval for the study Exclusion criteria
* 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:

Inclusion criteria

* Having a child between the ages of 6-12 diagnosed with cerebral palsy
* Being willing to participate in the study Exclusion criteria
* Not being willing to participate in the study
* Not knowing Turkish
* Not being able to read and write

Primary outcomes:
measure: PEDI-CAT (Pediatric Evaluation of Disability Inventory Computer Adaptive Test)
timeFrame: Single assessment conducted during the initial study visit
measure: LIFE-H 3.0 (The Assessment of life habits)
timeFrame: Single assessment conducted during the initial study visit
Secondary outcomes:
measure: Nottingham Health Profile
timeFrame: Single assessment conducted during the initial study visit
measure: Impact on Family Scale (IPFAM)
timeFrame: Single assessment conducted during the initial study visit
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Physical Therapy and Rehabilitation Cerebral Palsy and Pediatric Rehabilitation Unit
Study officials:
affiliation: Hacettepe University, Faculty of Physical Therapy and Rehabilitation
name: Mintaze Kerem-Gunel, Professor
role: STUDY_DIRECTOR
References: