Quality of Life in Children With Cerebral Palsy

February 26, 2024 updated by: Giuseppina Sgandurra, IRCCS Fondazione Stella Maris

Quality of Life in Children With Cerebral Palsy: the Impact of Social Participation, Motor and Cognitive Levels

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 individual's 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 person's "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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 individual's 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 child's 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 person's "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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

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

Study Locations

  • Italy
      • Pisa, Italy, 56128
        • IRCCS Fondazione Stella Maris

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

Non-Probability Sample

Study Population

Children with Cerebral Palsy

Description

Inclusion Criteria:

  • Children with confirmed diagnosis of CP

Exclusion Criteria:

  • None

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children with Cerebral Palsy
Children aged 4 to 12 with CP diagnosis
Other: Quality of Life and social participation in Italian children with CP
CP-QOL and PEM-CY questionnaires are fulfilled by families of children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of CP-QOL Child questionnaire
Time Frame: Months 1-32
The CP QOL-Child questionnaire (caregiver-proxy version) assesses the QOL of children aged 4 to 12 years (Waters et al., 2006, Davis et al., 2009). This questionnaire comprises 66 items and evaluates seven domains of QOL, including Social Wellbeing and Acceptance, Functioning, Participation and Physical Health, Emotional Wellbeing and Self-esteem, Access to Services, Pain and the Impact of Disability, and Family Health. Most of the items start with the question: "How do you think your child feels about...?" using a nine-point rating scale ranging from 1 (very unhappy) to 9 (very happy). Item ratings were transformed to a 0-100 scale, with the mean of item values computed for each domain.
Months 1-32

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of PEM-CY questionnaire
Time Frame: Months 1-32
The Participation and Environment Measure for Children and Youth (PEM-CY; Coster, Law, & Bedell, 2010) is a reliable and valid instrument for parent/caregiver reporting, designed to assess children's participation and their environment in three distinct settings: home, school, and the community. In the first section of the questionnaire parents asked to indicate how frequently their child has participated in specific activities in the last four months, how much he was involved and their change desire in child's participation. The last section investigates the impact of certain environmental features and the availability of resources. Response options are based on an 8- or 5-point scale or on a yes or no choice, scores are expressed as an average or percentage.
Months 1-32
Scores of Wechsler Intelligence scales
Time Frame: Months 1-32
Verbal and Non verbal intelligence indices are obtained by the Italian version of Wechsler Intelligence Scale for Children - Fourth Edition (VCI and PRI, WISC-IV, Wechsler, 2003) for 6- to 16-year-old children; the Italian version of Wechsler Preschool and Primary Scale for Intelligence - Third edition (VIQ and PIQ, WPPSI-III, Wechsler, 2002) or - Fourth Edition (VCI and PRI, WPPSI-IV, Wechsler, 2012) for 3- to 7-year-old children were administered.
Months 1-32

Collaborators and Investigators

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

Sponsor

IRCCS Fondazione Stella Maris

Investigators

  • Principal Investigator: Giuseppina Sgandurra, MD, PhD, IRCCS Fondazione Stella Maris

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

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 (Actual)

April 1, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fondazione Stella Maris

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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