Motor DisordersNCT06645717
Neuromotor Development and Motor Related Health Care in Children with a High Risk Neonatal Period
An observational study of Motor Disorders and Neurodevelopmental Disorders, run by Karolinska Institutet.
Trial summary
The overall aim of the study is to evaluate the prevalence of motor- and neurological disorders (cerebral pares and other less severe motor disorders) in Swedish infants with a high-risk neonatal period and to elucidate whether these children receive motor related health care (MRHC) at 2 and or 5,5 years of age. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Motor Disorders, Neurodevelopmental Disorders, Premature Birth
- How many people
- 2,900 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Oct 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Today, data from 2,900 children are available in the follow-up protocol for 5,5 years of age in the SNQ according to the vice registry manager for the SNQ registry (Stellan Håkansson 08-03-2023).
Who may be able to join
- Included in the SNQ registry and having a follow-up protocol for 2 and/or 5 years of age.
Who cannot join
- None if the above inclusion criteria ar true.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Neuromotor Development in Children Enrolled in the Swedish Neonatal Follow-up Program and Access to Motor Related Healthcare
The overall aim of the study is to evaluate the prevalence of motor- and neurological disorders (cerebral pares and other less severe motor disorders) in Swedish infants with a high-risk neonatal period and to elucidate whether these children receive motor related health care (MRHC) at 2 and or 5,5 years of age.
Read the detailed description
Specific aims:
- To evaluate the prevalence of cerebral pares (CP) and other motor impairments in Swedish infants with a high-risk neonatal period (total group and sub-groups), followed up at age 2 and or 5,5 years.
- To study how retinopathy of prematurity (ROP) affects the risk for later gross and fine motor impairments in children with a high-risk neonatal period, with specific reference to children born extremely preterm.
- To study the number of children, with a high-risk neonatal period having access to MRHC (defined as having at least one visit over the previous year to a physiotherapist and/or an occupational therapist).
- To evaluate possible associations between receiving MRHC and maternal-, pregnancy- and neonatal factors.
- To study the association between receiving MRHC and cognition, motor function, behavior, quality of life and autism spectrum disorders (ASD) at age 2 and 5,5 years.
- To study if there are regional differences in Sweden in follow-up of CP and less severe motor disorders at the age of 2 and 5,5 years.
- To assess the completeness and agreement of some developmental and motor disorders, neurosensory impairments and chronical diseases in the Swedish Neonatal Quality Register (SNQ) with the Swedish National Patient Register (NPR) and The Cerebral Palsy Follow-Up Program (CPUP).
- Conditions
- Motor Disorders, Neurodevelopmental Disorders, Premature Birth, Hypoxic-Ischemic Encephalopathy, Small for Gestational Age At Delivery
- Keywords
- brain, HIE, SGA, preterm, neurodevelopment, motor related healthcare, children, motor function
- Medical subject headings
- Motor Disorders, Neurodevelopmental Disorders, Premature Birth, Hypoxia-Ischemia, Brain
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement assessment battery for children Second Edition (MABC-2)
The MABC-2 is designed to identify and describe motor disorders in children and adolescents, from three to sixteen years of age. It gives information about both gross and fine motor functioning. It consists of eight tasks/items that are aggregated into three components: (1) Manual dexterity, that tests fine motor skills through three tasks, (2) Aiming and catching evaluates aiming and catching skills through two tasks/items, (3) Balance assesses gross motor skills through three tasks.
The scoring procedure includes transforming raw scores into age adjusted scaled scores (mean 10; SD 3) for each item. The scaled scores of items within the same component are summed to obtain a total component score which is then converted into a scaled score and a percentil rank. The scaled scores of alla items are then summed to provide a total motor score that is converted into a total scaled score and percentile. Higher scores indicate better performance.
Measured: Until 2026-10-01
Bayley Scales of Infant Development Third Edition (Bayley III)
The Bayley-III is an assessment tool to identify developmental impairments from birth to the age of 3. It includes cognitive, language, motor (gross and fine), social-emotional and adaptive behavior scales. It is often used in research and clinical work. Raw scores of successfully completed items are converted to scale scores and to composite scores. These scores are used to determine the child's performance compared with norms taken from typically developing children of their age (in months).
Measured: Until 2026-10-01
Wechsler Preschool and Primary Scale of Intelligence Fourth Edition (WPPSI-IV)
The WPPSI-IV is a measure of general cognitive development for preschoolers and young children. The test is divided in two age intervals, 2 years and 6 months to 3 years and 11 months, and from 4 years to 7 years and 7 months. The younger age interval is divided into three primary index scales, verbal comprehension index (VCI), visual spatial index (VSI), and working memory index (WMI) and the older age interval consists of five primary index scales VCI, VSI, WMI, fluid reasoning index (FRI), and processing speed index (PSI). These primary index scales put together give a full-scale intelligence quotient (FSIQ) score.
Measured: Until 2026-10-01
The developmental coordination disorder questionnaire 2007 (DCDQ'07)
DCDQ-07 is a brief parent questionnaire designed to screen for coordination disorders in children between 5 and 15. The DCDQ-07 is considered a valid clinical screening tool for children who have coordination disorders. DCDQ-07 has been validated against MABC-2. The questionnaire consists of 15 questions with answers from 1-5. All the answers are summed up together to a total score in the end. The higher the total score the less likely the child has developmental coordination disorder.
Measured: Until 2026-10-01
Movement Assessment battery for children Secondary Edition (MABC-2 checklist)
Parent and teacher reported MABC-2 checklist is a screening tool for motor impairments in children between 3 and 16 years of age. It meets standards for reliability and validity when used in research and every day clinical work.
The checklist contains two 15-item sections. Section A evaluates movement in both a static and/or predictable environment. Section B evaluates movement in a dynamic and/or unpredictable environment. The items in both sections are rated on a four-point liket rating scale ranging from very well to not close. The MABC-2 checklist total motor score is the sum of the scores for the two sections; the higher the score; the poorer the performance.
Measured: Until 2026-10-01
Kidsscreen 10
Kidsscreen 10 is used to assess self-reported subjective health and the mental, psychological and social well-being of children between 7 to 17 years of age. The instrument has shown adequate psychometrics. Kidsscreen 10 provides a global health related quality of life (HRQoL) and is recommended for use in larger studies.
The kid screen-10 score contains 10 items. Each item is answered on a 5-point response scale. The responses are coded so that higher indicate better HRQoL.
Measured: Until 2026-10-01
Pediatric Quality of Life Inventory - Family Impact Module (PedsQL)
Pedsql - Family Impact Module was designed to measure the impact of pediatric chronic health on the family and parents. This module encompasses six scales measuring parent self-reported functioning including physical, emotional, social and cognitive functioning, communication and worry. The module aslo measures parent-reported daily activities and family relationships. A 5-point response scale is used so that higher scores indicate better functioning.
Measured: Until 2026-10-01
MRHC motor related healthcare
Receiving MRHC will be defined as having at least one visit to a physiotherapist and/or an occupational therapist during the previous year.
Measured: Until 2026-10-01
Study specific questionaire
Study specific questionnaire about motor related health care and motor function. It consists of 6 main questions. The questionnaire does not give a total score but gives specific information about motor functioning, physical activity and visits to physiotherapists/pediatric neurologist/occupational therapist.
Measured: Until 2026-10-01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 2,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Örtqvist, Karolinska Institutet
- Investigators
- Maria Örtqvist, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645717
- Sponsor's protocol ID
- 2024-01633-01
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromotor Development in Children Enrolled in the Swedish Neonatal Follow-up Program and Access to Motor Related Healthcare
- ClinicalTrials.gov ID
- NCT06645717
- Acronym / sponsor ID
- 2024-01633-01
- Conditions
- Motor Disorders, Neurodevelopmental Disorders, Premature Birth, Hypoxic-Ischemic Encephalopathy, Small for Gestational Age At Delivery
- Keywords
- brain, HIE, SGA, preterm, neurodevelopment, motor related healthcare, children, motor function
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,900 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2034 (estimated)
- First posted
- 17 Oct 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.
The overall aim of the study is to evaluate the prevalence of motor- and neurological disorders (cerebral pares and other less severe motor disorders) in Swedish infants with a high-risk neonatal period and to elucidate whether these children receive motor related health care (MRHC) at 2 and or 5,5 years of age.
Detailed description
Specific aims:
- To evaluate the prevalence of cerebral pares (CP) and other motor impairments in Swedish infants with a high-risk neonatal period (total group and sub-groups), followed up at age 2 and or 5,5 years.
- To study how retinopathy of prematurity (ROP) affects the risk for later gross and fine motor impairments in children with a high-risk neonatal period, with specific reference to children born extremely preterm.
- To study the number of children, with a high-risk neonatal period having access to MRHC (defined as having at least one visit over the previous year to a physiotherapist and/or an occupational therapist).
- To evaluate possible associations between receiving MRHC and maternal-, pregnancy- and neonatal factors.
- To study the association between receiving MRHC and cognition, motor function, behavior, quality of life and autism spectrum disorders (ASD) at age 2 and 5,5 years.
- To study if there are regional differences in Sweden in follow-up of CP and less severe motor disorders at the age of 2 and 5,5 years.
- To assess the completeness and agreement of some developmental and motor disorders, neurosensory impairments and chronical diseases in the Swedish Neonatal Quality Register (SNQ) with the Swedish National Patient Register (NPR) and The Cerebral Palsy Follow-Up Program (CPUP).
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Today, data from 2,900 children are available in the follow-up protocol for 5,5 years of age in the SNQ according to the vice registry manager for the SNQ registry (Stellan Håkansson 08-03-2023).
Key inclusion criteria (1 listed)
- Included in the SNQ registry and having a follow-up protocol for 2 and/or 5 years of age.
Key exclusion criteria (1 listed)
- None if the above inclusion criteria ar true.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Movement assessment battery for children Second Edition (MABC-2)
Time frame: Until 2026-10-01
The MABC-2 is designed to identify and describe motor disorders in children and adolescents, from three to sixteen years of age. It gives information about both gross and fine motor functioning. It consists of eight tasks/items that are aggregated into three components: (1) Manual dexterity, that tests fine motor skills through three tasks, (2) Aiming and catching evaluates aiming and catching skills through two tasks/items, (3) Balance assesses gross motor skills through three tasks. The scoring procedure includes transforming raw scores into age adjusted scaled scores (mean 10; SD 3) for each item. The scaled scores of items within the same component are summed to obtain a total component score which is then converted into a scaled score and a percentil rank. The scaled scores of alla items are then summed to provide a total motor score that is converted into a total scaled score and percentile. Higher scores indicate better performance.
Bayley Scales of Infant Development Third Edition (Bayley III)
Time frame: Until 2026-10-01
The Bayley-III is an assessment tool to identify developmental impairments from birth to the age of 3. It includes cognitive, language, motor (gross and fine), social-emotional and adaptive behavior scales. It is often used in research and clinical work. Raw scores of successfully completed items are converted to scale scores and to composite scores. These scores are used to determine the child's performance compared with norms taken from typically developing children of their age (in months).
Wechsler Preschool and Primary Scale of Intelligence Fourth Edition (WPPSI-IV)
Time frame: Until 2026-10-01
The WPPSI-IV is a measure of general cognitive development for preschoolers and young children. The test is divided in two age intervals, 2 years and 6 months to 3 years and 11 months, and from 4 years to 7 years and 7 months. The younger age interval is divided into three primary index scales, verbal comprehension index (VCI), visual spatial index (VSI), and working memory index (WMI) and the older age interval consists of five primary index scales VCI, VSI, WMI, fluid reasoning index (FRI), and processing speed index (PSI). These primary index scales put together give a full-scale intelligence quotient (FSIQ) score.
The developmental coordination disorder questionnaire 2007 (DCDQ'07)
Time frame: Until 2026-10-01
DCDQ-07 is a brief parent questionnaire designed to screen for coordination disorders in children between 5 and 15. The DCDQ-07 is considered a valid clinical screening tool for children who have coordination disorders. DCDQ-07 has been validated against MABC-2. The questionnaire consists of 15 questions with answers from 1-5. All the answers are summed up together to a total score in the end. The higher the total score the less likely the child has developmental coordination disorder.
Movement Assessment battery for children Secondary Edition (MABC-2 checklist)
Time frame: Until 2026-10-01
Parent and teacher reported MABC-2 checklist is a screening tool for motor impairments in children between 3 and 16 years of age. It meets standards for reliability and validity when used in research and every day clinical work. The checklist contains two 15-item sections. Section A evaluates movement in both a static and/or predictable environment. Section B evaluates movement in a dynamic and/or unpredictable environment. The items in both sections are rated on a four-point liket rating scale ranging from very well to not close. The MABC-2 checklist total motor score is the sum of the scores for the two sections; the higher the score; the poorer the performance.
Kidsscreen 10
Time frame: Until 2026-10-01
Kidsscreen 10 is used to assess self-reported subjective health and the mental, psychological and social well-being of children between 7 to 17 years of age. The instrument has shown adequate psychometrics. Kidsscreen 10 provides a global health related quality of life (HRQoL) and is recommended for use in larger studies. The kid screen-10 score contains 10 items. Each item is answered on a 5-point response scale. The responses are coded so that higher indicate better HRQoL.
Pediatric Quality of Life Inventory - Family Impact Module (PedsQL)
Time frame: Until 2026-10-01
Pedsql - Family Impact Module was designed to measure the impact of pediatric chronic health on the family and parents. This module encompasses six scales measuring parent self-reported functioning including physical, emotional, social and cognitive functioning, communication and worry. The module aslo measures parent-reported daily activities and family relationships. A 5-point response scale is used so that higher scores indicate better functioning.
MRHC motor related healthcare
Time frame: Until 2026-10-01
Receiving MRHC will be defined as having at least one visit to a physiotherapist and/or an occupational therapist during the previous year.
Study specific questionaire
Time frame: Until 2026-10-01
Study specific questionnaire about motor related health care and motor function. It consists of 6 main questions. The questionnaire does not give a total score but gives specific information about motor functioning, physical activity and visits to physiotherapists/pediatric neurologist/occupational therapist.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Maria Örtqvist, PhD principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
An observational study of Motor Disorders and Neurodevelopmental Disorders, run by Karolinska Institutet.
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: opening soon, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela Nosko, MD (+46768494609, daniela.nosko@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement assessment battery for children Second Edition (MABC-2) (time frame: Until 2026-10-01). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2024.