Unilateral and Bilateral Cerebral PalsyNCT06288958
Quality of Life in Children With Cerebral Palsy
An observational study of Unilateral and Bilateral Cerebral Palsy, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Unilateral and Bilateral Cerebral Palsy
- What is being tested?
- Quality of Life and social participation in Italian children with CP
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2019to 31 Dec 2021
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with Cerebral Palsy
Who may be able to join
- Children with confirmed diagnosis of CP
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Unilateral and Bilateral Cerebral Palsy
- Being tested
- Quality of Life and social participation in Italian children with CP
- Keywords
- Cerebral Palsy, Quality of Life, Social participation, Cognitive Functioning, Motor Skills, Background Factors
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life and social participation in Italian children with CPOther
CP-QOL and PEM-CY questionnaires are fulfilled by families of children.
| Study group | Role | What they receive |
|---|---|---|
| Children with Cerebral Palsy | Children aged 4 to 12 with CP diagnosis Receives: Other: Quality of Life and social participation in Italian children with CP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of CP-QOL Child questionnaire
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.
Measured: Months 1-32
Secondary outcomes (2)
Score of PEM-CY questionnaire
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.
Measured: Months 1-32
Scores of Wechsler Intelligence scales
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.
Measured: Months 1-32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Apr 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Unilateral and Bilateral Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppina Sgandurra, IRCCS Fondazione Stella Maris
- Investigators
- Giuseppina Sgandurra, MD, PhD, Principal investigator, IRCCS Fondazione Stella Maris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288958
- Sponsor's protocol ID
- Fondazione Stella Maris
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
PubMed 17370477Boling S, Varho T, Kiviranta T, Haataja L. Quality of life of Finnish children with cerebral palsy. Disabil Rehabil. 2016;38(7):683-8. doi: 10.3109/09638288.2015.1061607. Epub 2015 Jun 29.
PubMed 26119576Omura J, Fuentes M, Bjornson K. Participation in Daily Life: Influence on Quality of Life in Ambulatory Children with Cerebral Palsy. PM R. 2018 Nov;10(11):1185-1191. doi: 10.1016/j.pmrj.2018.05.010. Epub 2018 May 18.
PubMed 29783065Bugusan S, Kahraman A, Elbasan B, Mutlu A. Do adolescents with cerebral palsy agree with their caregivers on their participation and quality of life? Disabil Health J. 2018 Apr;11(2):287-292. doi: 10.1016/j.dhjo.2017.10.009. Epub 2017 Oct 24.
PubMed 29100958Davis E, Mackinnon A, Waters E. Parent proxy-reported quality of life for children with cerebral palsy: is it related to parental psychosocial distress? Child Care Health Dev. 2012 Jul;38(4):553-60. doi: 10.1111/j.1365-2214.2011.01267.x. Epub 2011 Jun 15.
PubMed 21671983Shelly 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 18215191Radsel A, Osredkar D, Neubauer D. Health-related quality of life in children and adolescents with cerebral palsy. Zdr Varst. 2016 Jul 28;56(1):1-10. doi: 10.1515/sjph-2017-0001. eCollection 2017 Mar 1.
PubMed 28289457Majnemer A, Shevell M, Law M, Birnbaum R, Chilingaryan G, Rosenbaum P, Poulin C. Participation and enjoyment of leisure activities in school-aged children with cerebral palsy. Dev Med Child Neurol. 2008 Oct;50(10):751-8. doi: 10.1111/j.1469-8749.2008.03068.x.
PubMed 18834388Mc Manus V, Corcoran P, Perry IJ. Participation in everyday activities and quality of life in pre-teenage children living with cerebral palsy in South West Ireland. BMC Pediatr. 2008 Oct 31;8:50. doi: 10.1186/1471-2431-8-50.
PubMed 18976459Milicevic M, Nedovic G. Comparative study of home and community participation among children with and without cerebral palsy. Res Dev Disabil. 2018 Sep;80:74-83. doi: 10.1016/j.ridd.2018.06.010. Epub 2018 Jun 27.
PubMed 29957491Michelsen SI, Flachs EM, Damsgaard MT, Parkes J, Parkinson K, Rapp M, Arnaud C, Nystrand M, Colver A, Fauconnier J, Dickinson HO, Marcelli M, Uldall P. European study of frequency of participation of adolescents with and without cerebral palsy. Eur J Paediatr Neurol. 2014 May;18(3):282-94. doi: 10.1016/j.ejpn.2013.12.003. Epub 2013 Dec 25.
PubMed 24412031Imms C, Reilly S, Carlin J, Dodd K. Diversity of participation in children with cerebral palsy. Dev Med Child Neurol. 2008 May;50(5):363-9. doi: 10.1111/j.1469-8749.2008.02051.x. Epub 2008 Mar 18.
PubMed 18355337Engel-Yeger B, Jarus T, Anaby D, Law M. Differences in patterns of participation between youths with cerebral palsy and typically developing peers. Am J Occup Ther. 2009 Jan-Feb;63(1):96-104. doi: 10.5014/ajot.63.1.96.
PubMed 19192732Majnemer A, Shikako-Thomas K, Schmitz N, Shevell M, Lach L. Stability of leisure participation from school-age to adolescence in individuals with cerebral palsy. Res Dev Disabil. 2015 Dec;47:73-9. doi: 10.1016/j.ridd.2015.08.009. Epub 2015 Sep 2.
PubMed 26342327Almasri NA, Alquaqzeh FA. Determinants of Quality of Life of Children and Adolescents with Cerebral Palsy: A Systematic Review. Phys Occup Ther Pediatr. 2023;43(4):367-388. doi: 10.1080/01942638.2022.2162358. Epub 2023 Jan 1.
PubMed 36588347
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Children With Cerebral Palsy: the Impact of Social Participation, Motor and Cognitive Levels
- ClinicalTrials.gov ID
- NCT06288958
- Acronym / sponsor ID
- Fondazione Stella Maris
- Conditions
- Unilateral and Bilateral Cerebral Palsy
- Keywords
- Cerebral Palsy, Quality of Life, Social participation, Cognitive Functioning, Motor Skills, Background Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Cerebral Palsy | – | Other: Quality of Life and social participation in Italian children with CPChildren aged 4 to 12 with CP diagnosis |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with Cerebral Palsy
Key inclusion criteria (1 listed)
- Children with confirmed diagnosis of CP
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of Life and social participation in Italian children with CPCP-QOL and PEM-CY questionnaires are fulfilled by families of children. | Other | Children with Cerebral Palsy |
Primary outcome
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.
2 secondary outcomes
Score of PEM-CY questionnaire
Time frame: Months 1-32
Scores of Wechsler Intelligence scales
Time frame: Months 1-32
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 17370477Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
- Background: PubMed 26119576Boling S, Varho T, Kiviranta T, Haataja L. Quality of life of Finnish children with cerebral palsy. Disabil Rehabil. 2016;38(7):683-8. doi: 10.3109/09638288.2015.1061607. Epub 2015 Jun 29.
- Background: PubMed 29783065Omura J, Fuentes M, Bjornson K. Participation in Daily Life: Influence on Quality of Life in Ambulatory Children with Cerebral Palsy. PM R. 2018 Nov;10(11):1185-1191. doi: 10.1016/j.pmrj.2018.05.010. Epub 2018 May 18.
- Background: PubMed 29100958Bugusan S, Kahraman A, Elbasan B, Mutlu A. Do adolescents with cerebral palsy agree with their caregivers on their participation and quality of life? Disabil Health J. 2018 Apr;11(2):287-292. doi: 10.1016/j.dhjo.2017.10.009. Epub 2017 Oct 24.
- Background: PubMed 21671983Davis E, Mackinnon A, Waters E. Parent proxy-reported quality of life for children with cerebral palsy: is it related to parental psychosocial distress? Child Care Health Dev. 2012 Jul;38(4):553-60. doi: 10.1111/j.1365-2214.2011.01267.x. Epub 2011 Jun 15.
- Background: PubMed 18215191Shelly 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.
- Background: PubMed 28289457Radsel A, Osredkar D, Neubauer D. Health-related quality of life in children and adolescents with cerebral palsy. Zdr Varst. 2016 Jul 28;56(1):1-10. doi: 10.1515/sjph-2017-0001. eCollection 2017 Mar 1.
- Background: PubMed 18834388Majnemer A, Shevell M, Law M, Birnbaum R, Chilingaryan G, Rosenbaum P, Poulin C. Participation and enjoyment of leisure activities in school-aged children with cerebral palsy. Dev Med Child Neurol. 2008 Oct;50(10):751-8. doi: 10.1111/j.1469-8749.2008.03068.x.
- Background: PubMed 18976459Mc Manus V, Corcoran P, Perry IJ. Participation in everyday activities and quality of life in pre-teenage children living with cerebral palsy in South West Ireland. BMC Pediatr. 2008 Oct 31;8:50. doi: 10.1186/1471-2431-8-50.
- Background: PubMed 29957491Milicevic M, Nedovic G. Comparative study of home and community participation among children with and without cerebral palsy. Res Dev Disabil. 2018 Sep;80:74-83. doi: 10.1016/j.ridd.2018.06.010. Epub 2018 Jun 27.
- Background: PubMed 24412031Michelsen SI, Flachs EM, Damsgaard MT, Parkes J, Parkinson K, Rapp M, Arnaud C, Nystrand M, Colver A, Fauconnier J, Dickinson HO, Marcelli M, Uldall P. European study of frequency of participation of adolescents with and without cerebral palsy. Eur J Paediatr Neurol. 2014 May;18(3):282-94. doi: 10.1016/j.ejpn.2013.12.003. Epub 2013 Dec 25.
- Background: PubMed 18355337Imms C, Reilly S, Carlin J, Dodd K. Diversity of participation in children with cerebral palsy. Dev Med Child Neurol. 2008 May;50(5):363-9. doi: 10.1111/j.1469-8749.2008.02051.x. Epub 2008 Mar 18.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppina Sgandurra, MD, PhD principal investigator
IRCCS Fondazione Stella Maris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unilateral and Bilateral Cerebral Palsy, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of CP-QOL Child questionnaire (time frame: Months 1-32). 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 NCT06288958, which also lists 18 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 1 Mar 2024.