Children's Activities and Social Participation

NCT ID: NCT06876025

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-07

Study Completion Date

2023-11-30

Brief Summary

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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

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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.

Conditions

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Child Development Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Caregivers

Caregivers will respond to two of the three questionnaires: PEM-CY or YC-PEM, and PEDI

questionnaires

Intervention Type OTHER

Application of the questionnaires Measure of Participation and Environment - Children and Youth, (PEM-CY), or Measure of Participation and the environment - young children (YC-PEM), and the Pediatric Disability Assessment Inventory (PEDI).

Interventions

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questionnaires

Application of the questionnaires Measure of Participation and Environment - Children and Youth, (PEM-CY), or Measure of Participation and the environment - young children (YC-PEM), and the Pediatric Disability Assessment Inventory (PEDI).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Federal Institute of Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Elisa Beatriz van Eyken

PhD Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elisa B Van Eyken, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Federal de Educação, Ciência e Tecnologia do Rio de Janeiro

Locations

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Campus Realengo do IFRJ

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 31313843 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30294776 (View on PubMed)

Coster W, Law M, Bedell G, Khetani M, Cousins M, Teplicky R. Development of the participation and environment measure for children and youth: conceptual basis. Disabil Rehabil. 2012;34(3):238-46. doi: 10.3109/09638288.2011.603017.

Reference Type BACKGROUND
PMID: 21981404 (View on PubMed)

Krieger B, Schulze C, Boyd J, Amann R, Piskur B, Beurskens A, Teplicky R, Moser A. Cross-cultural adaptation of the Participation and Environment Measure for Children and Youth (PEM-CY) into German: a qualitative study in three countries. BMC Pediatr. 2020 Oct 24;20(1):492. doi: 10.1186/s12887-020-02343-y.

Reference Type BACKGROUND
PMID: 33099320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29498960 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29574916 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27333475 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27833905 (View on PubMed)

Lexell J, Brogardh C. The use of ICF in the neurorehabilitation process. NeuroRehabilitation. 2015;36(1):5-9. doi: 10.3233/NRE-141184.

Reference Type BACKGROUND
PMID: 25547759 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24754598 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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CAAE 59793122.8.0000.5268

Identifier Type: OTHER

Identifier Source: secondary_id

559

Identifier Type: -

Identifier Source: org_study_id

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