Clinical trial NCT06876025: Children's Activities and Social Participation
Official title: Activities and Social Participation of Children With Atypical Motor Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Development Disorder
Keywords: ICF
Child development
Social participation
Child
Lead sponsor: Federal Institute of Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2025-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Legal guardians of children from 0 to 11 years and 11 months of age with clinical diagnosis of nervous system health conditions with motor limitations.

Brief summary: The goal of this observational study is to learn the perception of caregivers about the limitations of activities, and the restriction in the social participation of children who are in Neurofunctional physiotherapy. The main questions it aims to answer are:

* What is the ability to perform tasks, and
* how is the social participation of children with atypical motor development?

Participants will answer two of three questionnaires:

* The Participation and Environment Measure - Children and Youth or the Young Children's Participation and Environment Measure, depending on the age of their child

.The Pediatric Evaluation of Disability Inventory - PEDI.

Detailed description: The limitation in the execution of activities and tasks, as well as the restriction in the social participation of children considered atypical are considered biopsychosocial aspects of health according to the model of the International Classification of Disability and Health Functionality (ICF). The perception of the difficulties and limitations in the execution of the tasks, the barriers and facilitators of the environments and the participation and its restrictions, can be important to follow minimal or expressive improvements, indicate important changes in the environment and favor positive changes in the lives of children.

Eligibility criteria: Inclusion Criteria:

* Legal guardians of children aged up to 11 years and 11 months with motor disability
* Most be in Physio-therapeutic care at the School Clinic on the Realengo campus of the Federal Institute of Education, Science and Technology of Rio de Janeiro.

Exclusion Criteria:

* Guardians of children with a health condition associated with the Nervous System without motor limitations
* Other health conditions.

Primary outcomes:
measure: Perception of caregivers/guardians of children with neuromotor disabilities regarding participation in three sections: home, school, and community.
timeFrame: 4 months
measure: Perception of caregivers/guardians of children with neuromotor disabilities regarding environmental factors that may be barriers or facilitators in three sections: home, school, and community.
timeFrame: 4 months
measure: Perception of caregivers/guardians of children with neuromotor disabilities about the child's performance in daily activities
timeFrame: 4 months
measure: Perception of caregivers/guardians of children with neuromotor disabilities about the child's mobility and the need for caregiver help
timeFrame: 4 months
measure: Perception of caregivers/guardians of children with neuromotor disabilities about the child's need for changes in the environment and in the child
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Campus Realengo do IFRJ
state: RJ
Study officials:
affiliation: Instituto Federal de Educação, Ciência e Tecnologia do Rio de Janeiro
name: Elisa B Van Eyken, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bosak DL, Jarvis JM, Khetani MA. Caregiver creation of participation-focused care plans using Participation and Environment Measure Plus (PEM+), an electronic health tool for family-centred care. Child Care Health Dev. 2019 Nov;45(6):791-798. doi: 10.1111/cch.12709. Epub 2019 Jul 30.
citation: Burgess A, Boyd RN, Ziviani J, Ware RS, Sakzewski L. Self-care and manual ability in preschool children with cerebral palsy: a longitudinal study. Dev Med Child Neurol. 2019 May;61(5):570-578. doi: 10.1111/dmcn.14049. Epub 2018 Oct 7.
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citation: Thompson SV, Cech DJ, Cahill SM, Krzak JJ. Linking the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT) to the International Classification of Function. Pediatr Phys Ther. 2018 Apr;30(2):113-118. doi: 10.1097/PEP.0000000000000483.
citation: Khetani MA, Albrecht EC, Jarvis JM, Pogorzelski D, Cheng E, Choong K. Determinants of change in home participation among critically ill children. Dev Med Child Neurol. 2018 Aug;60(8):793-800. doi: 10.1111/dmcn.13731. Epub 2018 Mar 25.
citation: Mancini MC, Coster WJ, Amaral MF, Avelar BS, Freitas R, Sampaio RF. New version of the Pediatric Evaluation of Disability Inventory (PEDI-CAT): translation, cultural adaptation to Brazil and analyses of psychometric properties. Braz J Phys Ther. 2016 Nov-Dec;20(6):561-570. doi: 10.1590/bjpt-rbf.2014.0166. Epub 2016 Jun 16.
citation: Miller AR, Rosenbaum P. Perspectives on "Disease" and "Disability" in Child Health: The Case of Childhood Neurodisability. Front Public Health. 2016 Oct 26;4:226. doi: 10.3389/fpubh.2016.00226. eCollection 2016.
citation: Lexell J, Brogardh C. The use of ICF in the neurorehabilitation process. NeuroRehabilitation. 2015;36(1):5-9. doi: 10.3233/NRE-141184.
citation: Bornbaum CC, Day AM, Izaryk K, Morrison SJ, Ravenek MJ, Sleeth LE, Skarakis-Doyle E. Exploring use of the ICF in health education. Disabil Rehabil. 2015;37(2):179-86. doi: 10.3109/09638288.2014.910558. Epub 2014 Apr 22.