Child Development DisorderNCT06876025
Children's Activities and Social Participation
An observational study of Child Development Disorder, run by Federal Institute of Rio de Janeiro at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Child Development Disorder
- What is being tested?
- questionnaires
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Oct 2022to 30 Nov 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Guardians of children with a health condition associated with the Nervous System without motor limitations
- Other health conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Activities and Social Participation of Children With Atypical Motor Development
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.
Read the 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.
- Conditions
- Child Development Disorder
- Being tested
- questionnaires
- Keywords
- ICF, Child development, Social participation, Child
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | Caregivers will respond to two of the three questionnaires: PEM-CY or YC-PEM, and PEDI Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of caregivers/guardians of children with neuromotor disabilities regarding participation in three sections: home, school, and community.
Evaluated by PEM-CY and YC-PEM, each item on participation is evaluated in three dimensions: frequency (seven-point scale), involvement (five-point scale) and desire for change (scores from zero to 100%). The environment, in turn, is evaluated by its characteristics, as well as by the availability of services and resources (scores from zero to 100%).
Measured: 4 months
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.
Evaluated by PEM-CY and YC-PEM, each item on participation is evaluated in three dimensions: frequency (seven-point scale), involvement (five-point scale) and desire for change (scores from zero to 100%). The environment, in turn, is evaluated by its characteristics, as well as by the availability of services and resources (scores from zero to 100%).
Measured: 4 months
Perception of caregivers/guardians of children with neuromotor disabilities about the child's performance in daily activities
Evaluated by PEDI, the score of Part I is the sum of the items scored with 1, that is, items that represent the ability to perform the activity. In Part II, each item can be scored between 0 and 5 points. Receives 5 the item in which the child performs the task independently and 0 when it needs full assistance. Scores 4 (supervision), 3 (minimum assistance), 2 (moderate assistance) and 1 (maximum assistance) represent the amount of help the child receives in the activities. These points are also added. Part 3 is qualitative.
Measured: 4 months
Perception of caregivers/guardians of children with neuromotor disabilities about the child's mobility and the need for caregiver help
Evaluated by PEDI, the score of Part I is the sum of the items scored with 1, that is, items that represent the ability to perform the activity. In Part II, each item can be scored between 0 and 5 points. Receives 5 the item in which the child performs the task independently and 0 when it needs full assistance. Scores 4 (supervision), 3 (minimum assistance), 2 (moderate assistance) and 1 (maximum assistance) represent the amount of help the child receives in the activities. These points are also added. Part 3 is qualitative.
Measured: 4 months
Perception of caregivers/guardians of children with neuromotor disabilities about the child's need for changes in the environment and in the child
Evaluated by PEDI, the score of Part I is the sum of the items scored with 1, that is, items that represent the ability to perform the activity. In Part II, each item can be scored between 0 and 5 points. Receives 5 the item in which the child performs the task independently and 0 when it needs full assistance. Scores 4 (supervision), 3 (minimum assistance), 2 (moderate assistance) and 1 (maximum assistance) represent the amount of help the child receives in the activities. These points are also added. Part 3 is qualitative.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start7 Oct 2022
- Primary completion25 Sep 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Child Development DisorderStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Institute of Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Elisa Beatriz van Eyken, Federal Institute of Rio de Janeiro
- Investigators
- Elisa B Van Eyken, PhD, Principal investigator, Instituto Federal de Educação, Ciência e Tecnologia do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876025
- Sponsor's protocol ID
- 559
- Other IDs
- CAAE 59793122.8.0000.5268
- Status last verified
- Mar 2025
- First submitted
- 6 Jun 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31313843Burgess 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.
PubMed 30294776Coster 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.
PubMed 21981404Krieger 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.
PubMed 33099320Thompson 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.
PubMed 29498960Khetani 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.
PubMed 29574916Mancini 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.
PubMed 27333475Miller 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.
PubMed 27833905Lexell J, Brogardh C. The use of ICF in the neurorehabilitation process. NeuroRehabilitation. 2015;36(1):5-9. doi: 10.3233/NRE-141184.
PubMed 25547759Bornbaum 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.
PubMed 24754598
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activities and Social Participation of Children With Atypical Motor Development
- ClinicalTrials.gov ID
- NCT06876025
- Acronym / sponsor ID
- 559
- Conditions
- Child Development Disorder
- Keywords
- ICF, Child development, Social participation, Child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal Institute of Rio de JaneiroUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 14 Mar 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers | – | Other: questionnairesCaregivers will respond to two of the three questionnaires: PEM-CY or YC-PEM, and PEDI |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Guardians of children with a health condition associated with the Nervous System without motor limitations
- Other health conditions.
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 |
|---|---|---|
| questionnairesApplication 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). | Other | Caregivers |
Primary outcome
Perception of caregivers/guardians of children with neuromotor disabilities regarding participation in three sections: home, school, and community.
Time frame: 4 months
Evaluated by PEM-CY and YC-PEM, each item on participation is evaluated in three dimensions: frequency (seven-point scale), involvement (five-point scale) and desire for change (scores from zero to 100%). The environment, in turn, is evaluated by its characteristics, as well as by the availability of services and resources (scores from zero to 100%).
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.
Time frame: 4 months
Evaluated by PEM-CY and YC-PEM, each item on participation is evaluated in three dimensions: frequency (seven-point scale), involvement (five-point scale) and desire for change (scores from zero to 100%). The environment, in turn, is evaluated by its characteristics, as well as by the availability of services and resources (scores from zero to 100%).
Perception of caregivers/guardians of children with neuromotor disabilities about the child's performance in daily activities
Time frame: 4 months
Evaluated by PEDI, the score of Part I is the sum of the items scored with 1, that is, items that represent the ability to perform the activity. In Part II, each item can be scored between 0 and 5 points. Receives 5 the item in which the child performs the task independently and 0 when it needs full assistance. Scores 4 (supervision), 3 (minimum assistance), 2 (moderate assistance) and 1 (maximum assistance) represent the amount of help the child receives in the activities. These points are also added. Part 3 is qualitative.
Perception of caregivers/guardians of children with neuromotor disabilities about the child's mobility and the need for caregiver help
Time frame: 4 months
Evaluated by PEDI, the score of Part I is the sum of the items scored with 1, that is, items that represent the ability to perform the activity. In Part II, each item can be scored between 0 and 5 points. Receives 5 the item in which the child performs the task independently and 0 when it needs full assistance. Scores 4 (supervision), 3 (minimum assistance), 2 (moderate assistance) and 1 (maximum assistance) represent the amount of help the child receives in the activities. These points are also added. Part 3 is qualitative.
Perception of caregivers/guardians of children with neuromotor disabilities about the child's need for changes in the environment and in the child
Time frame: 4 months
Evaluated by PEDI, the score of Part I is the sum of the items scored with 1, that is, items that represent the ability to perform the activity. In Part II, each item can be scored between 0 and 5 points. Receives 5 the item in which the child performs the task independently and 0 when it needs full assistance. Scores 4 (supervision), 3 (minimum assistance), 2 (moderate assistance) and 1 (maximum assistance) represent the amount of help the child receives in the activities. These points are also added. Part 3 is qualitative.
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 14 Mar 2025.
- Background: PubMed 31313843Bosak 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.
- Background: PubMed 30294776Burgess 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.
- Background: PubMed 21981404Coster 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.
- Background: PubMed 33099320Krieger 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.
- Background: PubMed 29498960Thompson 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.
- Background: PubMed 29574916Khetani 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.
- Background: PubMed 27333475Mancini 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.
- Background: PubMed 27833905Miller 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.
- Background: PubMed 25547759Lexell J, Brogardh C. The use of ICF in the neurorehabilitation process. NeuroRehabilitation. 2015;36(1):5-9. doi: 10.3233/NRE-141184.
- Background: PubMed 24754598Bornbaum 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.
- PEM-CY - QuestionaireLink provided by the sponsor.
- YC-PEM - QuestionaireLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Elisa B Van Eyken, PhD principal investigator
Instituto Federal de Educação, Ciência e Tecnologia do Rio de Janeiro
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 Child Development Disorder, run by Federal Institute of Rio de Janeiro at 1 site in Brazil.
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 2 inclusion and 2 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 14 Mar 2025. 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 Brazil. 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?
Perception of caregivers/guardians of children with neuromotor disabilities regarding participation in three sections: home, school, and community. (time frame: 4 months). The study lists 5 primary outcomes in all. 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 NCT06876025, which also lists 10 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 14 Mar 2025.