Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288958
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2024-02-26
Brief Title:
Quality of Life in Children With Cerebral Palsy
Sponsor:
IRCCS Fondazione Stella Maris
Organization:
IRCCS Fondazione Stella Maris
Study Overview
Official Title:
Quality of Life in Children With Cerebral Palsy the Impact of Social Participation Motor and Cognitive Levels
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cerebral Palsy CP is an umbrella term that defines a group of permanent disorders of movement and posture happening during the developing foetal or infant brain In addition to the main motor symptoms other clinical disturbances are associated CP represents a clinical condition with an impact in Quality Of Life QOL and social participation as reported in different countries QOL is a multidimensional construct defined as an individuals perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals expectations standards and concerns WHOQOL 1998
In order to best capture the peculiarities of CP specific questionnaires were carried out to analyse the QOL in this clinical population The Cerebral Palsy Quality of Life Questionnaire for Children CP QOL-Child is an internationally recognized CP-specific instrument based on the International Classification of Functioning Disability and Health ICF framework Many studies have used this instrument showing a lower QOL in children with CP compared to their typical developing peers In literature several studies have shown that children with CP are at risk of experiencing activity limitations and participation restriction and which can potentially affect their QOL Participation in daily-life activities defined as a persons involvement in a life situation and participation restriction characterised as problems an individual may experience in involvement in life situations ICF World Health Organization 2001 Studies aimed at describing participation in daily-life activities in CP have consistently found lower frequencies and fewer activities in children and adolescents with CP In order to gain an overall picture of the QOL and participation of children and adolescents with CP several studies underline the importance of analysing other background factors such as motor and cognitive functioning pain perception and individual characteristics
The present study aims to deeper understand the perception of QOL and social participation in a group of Italian children with CP as reported by their parents using two commonly used questionnaires in the CP population CP-QOL and PEM-CY In addition this study aims to explore the roles of specific clinical variables such as motor function and cognitive level on parental perceptions of QOL in the development of QOL and participation
In order to best capture the peculiarities of CP specific questionnaires were carried out to analyse the QOL in this clinical population The Cerebral Palsy Quality of Life Questionnaire for Children CP QOL-Child is an internationally recognized CP-specific instrument based on the International Classification of Functioning Disability and Health ICF framework Many studies have used this instrument showing a lower QOL in children with CP compared to their typical developing peers In literature several studies have shown that children with CP are at risk of experiencing activity limitations and participation restriction and which can potentially affect their QOL Participation in daily-life activities defined as a persons involvement in a life situation and participation restriction characterised as problems an individual may experience in involvement in life situations ICF World Health Organization 2001 Studies aimed at describing participation in daily-life activities in CP have consistently found lower frequencies and fewer activities in children and adolescents with CP In order to gain an overall picture of the QOL and participation of children and adolescents with CP several studies underline the importance of analysing other background factors such as motor and cognitive functioning pain perception and individual characteristics
The present study aims to deeper understand the perception of QOL and social participation in a group of Italian children with CP as reported by their parents using two commonly used questionnaires in the CP population CP-QOL and PEM-CY In addition this study aims to explore the roles of specific clinical variables such as motor function and cognitive level on parental perceptions of QOL in the development of QOL and participation
Detailed Description:
Cerebral Palsy CP is defined as a group of permanent disorders of movement and posture occurring in the developing foetal or infant brain Rosenbaum et al 2007 Various clinical disturbances including behavior cognition communication sensation perception epilepsy musculoskeletal problems are also associated CP represents a clinical condition with an impact in Quality Of Life QOL and social participation as reported in different countries Böling et al 2016 Omura et al 2018 Quality of life QOL is a multidimensional construct defined as an individuals perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals expectations standards and concerns WHOQOL 1998 QOL concerns several domains such as material conditions health status functional abilities social interactions and emotional well-being In the case of children and adolescents these aspects can be assessed by gathering information from the children themselves or their parents The literature frequently documents notable differences between the quality of life QOL reports of children and their parents In many instances children and adolescents tend to express higher QOL assessments across different domains when compared to the evaluations provided by their caregivers Davis et al 2009 Parental distress also plays a crucial role in influencing their perception of their childs condition
Given the particularity of CP and the variety of associated disorders specific questionnaires were developed to analyse the QOL in this clinical population in order to deeper understand the difficulties that arise An example is the Cerebral Palsy Quality of Life Questionnaire for Children CP QOL-Child it is an internationally recognized CP-specific instrument based on the International Classification of Functioning Disability and Health ICF framework It was developed by an international multidisciplinary team of clinical and child health researchers in collaboration with parents and children with CP and has been used in various countries Many studies using this instrument have observed that children with CP show a good level of QOL but lower than typically population Radsel et al 2016
Furthermore it has been shown in the literature that children with CP often experience restriction in participation and activities compared to their peers these limitations may contribute to affecting QOL of this clinical population Participation in daily-life activities defined as a persons involvement in a life situation and participation restriction characterised as problems an individual may experience in involvement in life situations ICF World Health Organization 2001 Several studies exploring daily functioning in social and home activities and the relationship between the individual and their environment found lower participation in children and adolescents with CP respect to their peers The level of participation seems to be a factor that influences the QOL of this clinical population In order to better comprehend QOL and social participation in children and adolescents with CP it is important analyse different background factors such as motor functioning pain perception and individual characteristics Makris et al 2021 There is widespread consensus in the literature on the potential predictive role of cognitive functioning in QOL and social participation although there are few studies on the impact of intellectual disability on the QOL of children and adolescents with CP The present study aims to deeper understand the perception of QOL and social participation of a group of Italian children with CP To pursue this their parents complete the CP QOL-Child Primary Caregiver and PEM-CY questionnaires commonly used in the CP population In addition this study aims to explore the roles of specific clinical variables such as motor function and cognitive level on parental perceptions of QOL in the development of QOL and participation For this reason psychological assessment is conducted to evaluate intellectual abilities and motor assessment to describe the manual ability and gross motor skills and the independence in daily activities
Given the particularity of CP and the variety of associated disorders specific questionnaires were developed to analyse the QOL in this clinical population in order to deeper understand the difficulties that arise An example is the Cerebral Palsy Quality of Life Questionnaire for Children CP QOL-Child it is an internationally recognized CP-specific instrument based on the International Classification of Functioning Disability and Health ICF framework It was developed by an international multidisciplinary team of clinical and child health researchers in collaboration with parents and children with CP and has been used in various countries Many studies using this instrument have observed that children with CP show a good level of QOL but lower than typically population Radsel et al 2016
Furthermore it has been shown in the literature that children with CP often experience restriction in participation and activities compared to their peers these limitations may contribute to affecting QOL of this clinical population Participation in daily-life activities defined as a persons involvement in a life situation and participation restriction characterised as problems an individual may experience in involvement in life situations ICF World Health Organization 2001 Several studies exploring daily functioning in social and home activities and the relationship between the individual and their environment found lower participation in children and adolescents with CP respect to their peers The level of participation seems to be a factor that influences the QOL of this clinical population In order to better comprehend QOL and social participation in children and adolescents with CP it is important analyse different background factors such as motor functioning pain perception and individual characteristics Makris et al 2021 There is widespread consensus in the literature on the potential predictive role of cognitive functioning in QOL and social participation although there are few studies on the impact of intellectual disability on the QOL of children and adolescents with CP The present study aims to deeper understand the perception of QOL and social participation of a group of Italian children with CP To pursue this their parents complete the CP QOL-Child Primary Caregiver and PEM-CY questionnaires commonly used in the CP population In addition this study aims to explore the roles of specific clinical variables such as motor function and cognitive level on parental perceptions of QOL in the development of QOL and participation For this reason psychological assessment is conducted to evaluate intellectual abilities and motor assessment to describe the manual ability and gross motor skills and the independence in daily activities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None