Cerebral PalsyNCT06015347
The Relationship Between Developmental Level in Infancy and Preschool Motor Performance in Risky Infants
An observational study of Cerebral Palsy and Developmental Coordination Disorder, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The primary purpose of this study is to evaluate the relationship between the developmental level between 1-18 months and gross motor performance in the preschool period in risky infants followed up from a center for early intervention, and to determine the risk of developmental coordination disorder in the preschool… Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Developmental Coordination Disorder
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 30 Nov 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: At-risk infants currently aged 4-6 years and evaluated with the Alberta Infant Motor Scale
Who may be able to join
- To take part in the risky baby classification,
- Being between the ages of 4-6,
- To have been evaluated with the Alberta Infant Motor Scale at the Turkish Spastic Children Foundation Family Counseling Center,
- To agree to participate in the study and to have the informed consent form approved by the family.
Who cannot join
- The family does not approve the informed consent form,
- Not being evaluated with the Alberta Infant Motor Scale,
- Diagnosis of Down syndrome and genetic syndrome,
- Being outside the age range,
- Currently having a health problem that would prevent assessment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Turkish Spastic Children Foundation
Istanbul, Atasehir
About this study
Official title: The Relationship Between Motor Development Between 1-18 Months and the Risk of Developmental Coordination Disorder (DCD) in the Preschool Period and Cerebral Palsy (CP) in Risky Infants
The primary purpose of this study is to evaluate the relationship between the developmental level between 1-18 months and gross motor performance in the preschool period in risky infants followed up from a center for early intervention, and to determine the risk of developmental coordination disorder in the preschool period in risky infants.Gross Motor Function Measurement-88 will be applied to children diagnosed with cerebral palsy in the pre-school period to evaluate motor performance, among risky infants evaluated by Alberta Infant Motor Scale between 1-18 months.
Developmental Coordination Disorder Questionnaire will be applied to healthy children in order to evaluate the risk of gross motor performance and developmental coordination disorder.
Read the detailed description
Risky infants are at risk in terms of development. Cerebral palsy, mental retardation, visual and hearing disorders are seen as major neurodevelopmental disorders, developmental coordination disorder, attention deficit and hyperactivity disorder and learning disability are seen as minor. In order to detect major and minor disorders that may be seen in the future, these infants should be evaluated periodically in terms of neurodevelopment from birth.There are many reliable tests in the neurodevelopmental evaluation of risky infants, and one of them is the Alberta Infant Motor Scale.
Alberta Infant Motor Scale (AIMS) assesses motor performance and level of development from birth to 18 months. AIMS finds a total of 58 items in 4 different positions, and each item is 1 point. The scores obtained in all positions are added together and this score is converted into a percentile score that shows the baby's status relative to his/her peers. When looking at the norm chart of AIMS, there are 5%, 10%, 25%, 50%, 75%, and 90% lines. The 5% and 10% norm lines are used as cutoff lines for abnormal motor development.
Gross Motor Function Measure-88 is used to evaluate gross motor performance and function change in children aged 15 months to 13 years with cerebral palsy and Down syndrome. There are a total of 88 items in 5 categories (supine and prone 17, sitting 20, crawling and kneeling 14, standing 13, walking, running, and climbing stairs 24). Scoring is done according to the ability to perform gross motor functions correctly. Scoring is done in the range of 0 - 3. If he/she starts the activity, 0 points, 1 point if he/she starts the activity, 2 points if he/she completes the activity partially, and 3 points if he/she completes the activity independently. Categories and total scores are calculated as a percentage (%).
Developmental Coordination Disorder Questionnaire is a 15-item questionnaire used to measure developmental coordination disorder risk and evaluate motor performance and skills in children aged 5-15 years. It consists of 15 items. Scoring is between 1 and 5 (1 = not similar, 5 = very similar). The maximum score that can be obtained from the test is 75. The range of scores indicating the risk of developmental coordination disorder varies according to age. 5-7 years - 15-46 points; 8-9 years - 15-55 points; It means that there is a risk of DCD developmental coordination disorder between the ages of 10-15 - 15-57 points.
- Keywords
- Cerebral Palsy, Developmental Coordination Disorder, Infant, Premature, Child Development
- Medical subject headings
- Cerebral Palsy, Motor Skills Disorders, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Assessment | Infants at risk rated with the Alberta Infant Motor Scale between 1-18 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental Coordination Disorder Questionnaire
Developmental Coordination Disorder Questionnaire is a 15-item questionnaire used to measure developmental coordination disorder risk and evaluate motor performance and skills in children aged 5-15 years. It consists of 15 items. Scoring is between 1 and 5 (1 = not similar, 5 = very similar). The maximum score that can be obtained from the test is 75. The range of scores indicating the risk of developmental coordination disorder varies according to age. 5-7 years - 15-46 points; 8-9 years - 15-55 points; It means that there is a risk of developmental coordination disorder between the ages of 10-15 - 15-57 points.
Measured: 4-6 years
Secondary outcomes (1)
Gross Motor Function Measure-88
Gross Motor Function Measure-88 is used to evaluate gross motor performance and function change in children aged 15 months to 13 years with cerebral palsy and Down syndrome. There are a total of 88 items in 5 categories (supine and prone 17, sitting 20, crawling and kneeling 14, standing 13, walking, running, and climbing stairs 24). Scoring is done according to the ability to perform gross motor functions correctly. Scoring is done in the range of 0 - 3. If he/she starts the activity, 0 points, 1 point if he/she starts the activity, 2 points if he/she completes the activity partially, and 3 points if he/she completes the activity independently. Categories and total scores are calculated as a percentage (%).
Measured: 4-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Jun 2021
- Primary completion15 Aug 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Karanlik, Marmara University
- Investigators
- Ozge KARANLIK, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015347
- Sponsor's protocol ID
- MU-FTR-OK-01
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Motor Development Between 1-18 Months and the Risk of Developmental Coordination Disorder (DCD) in the Preschool Period and Cerebral Palsy (CP) in Risky Infants
- ClinicalTrials.gov ID
- NCT06015347
- Acronym / sponsor ID
- MU-FTR-OK-01
- Keywords
- Cerebral Palsy, Developmental Coordination Disorder, Infant, Premature, Child Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 29 Aug 2023 (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 primary purpose of this study is to evaluate the relationship between the developmental level between 1-18 months and gross motor performance in the preschool period in risky infants followed up from a center for early intervention, and to determine the risk of developmental coordination disorder in the preschool period in risky infants.Gross Motor Function Measurement-88 will be applied to children diagnosed with cerebral palsy in the pre-school period to evaluate motor performance, among risky infants evaluated by Alberta Infant Motor Scale between 1-18 months.
Developmental Coordination Disorder Questionnaire will be applied to healthy children in order to evaluate the risk of gross motor performance and developmental coordination disorder.
Detailed description
Risky infants are at risk in terms of development. Cerebral palsy, mental retardation, visual and hearing disorders are seen as major neurodevelopmental disorders, developmental coordination disorder, attention deficit and hyperactivity disorder and learning disability are seen as minor. In order to detect major and minor disorders that may be seen in the future, these infants should be evaluated periodically in terms of neurodevelopment from birth.There are many reliable tests in the neurodevelopmental evaluation of risky infants, and one of them is the Alberta Infant Motor Scale.
Alberta Infant Motor Scale (AIMS) assesses motor performance and level of development from birth to 18 months. AIMS finds a total of 58 items in 4 different positions, and each item is 1 point. The scores obtained in all positions are added together and this score is converted into a percentile score that shows the baby's status relative to his/her peers. When looking at the norm chart of AIMS, there are 5%, 10%, 25%, 50%, 75%, and 90% lines. The 5% and 10% norm lines are used as cutoff lines for abnormal motor development.
Gross Motor Function Measure-88 is used to evaluate gross motor performance and function change in children aged 15 months to 13 years with cerebral palsy and Down syndrome. There are a total of 88 items in 5 categories (supine and prone 17, sitting 20, crawling and kneeling 14, standing 13, walking, running, and climbing stairs 24). Scoring is done according to the ability to perform gross motor functions correctly. Scoring is done in the range of 0 - 3. If he/she starts the activity, 0 points, 1 point if he/she starts the activity, 2 points if he/she completes the activity partially, and 3 points if he/she completes the activity independently. Categories and total scores are calculated as a percentage (%).
Developmental Coordination Disorder Questionnaire is a 15-item questionnaire used to measure developmental coordination disorder risk and evaluate motor performance and skills in children aged 5-15 years. It consists of 15 items. Scoring is between 1 and 5 (1 = not similar, 5 = very similar). The maximum score that can be obtained from the test is 75. The range of scores indicating the risk of developmental coordination disorder varies according to age. 5-7 years - 15-46 points; 8-9 years - 15-55 points; It means that there is a risk of DCD developmental coordination disorder between the ages of 10-15 - 15-57 points.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment | – | –Infants at risk rated with the Alberta Infant Motor Scale between 1-18 months |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- At-risk infants currently aged 4-6 years and evaluated with the Alberta Infant Motor Scale
Key inclusion criteria (4 listed)
- To take part in the risky baby classification,
- Being between the ages of 4-6,
- To have been evaluated with the Alberta Infant Motor Scale at the Turkish Spastic Children Foundation Family Counseling Center,
- To agree to participate in the study and to have the informed consent form approved by the family.
Key exclusion criteria (5 listed)
- The family does not approve the informed consent form,
- Not being evaluated with the Alberta Infant Motor Scale,
- Diagnosis of Down syndrome and genetic syndrome,
- Being outside the age range,
- Currently having a health problem that would prevent assessment.
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
Developmental Coordination Disorder Questionnaire
Time frame: 4-6 years
Developmental Coordination Disorder Questionnaire is a 15-item questionnaire used to measure developmental coordination disorder risk and evaluate motor performance and skills in children aged 5-15 years. It consists of 15 items. Scoring is between 1 and 5 (1 = not similar, 5 = very similar). The maximum score that can be obtained from the test is 75. The range of scores indicating the risk of developmental coordination disorder varies according to age. 5-7 years - 15-46 points; 8-9 years - 15-55 points; It means that there is a risk of developmental coordination disorder between the ages of 10-15 - 15-57 points.
1 secondary outcome
Gross Motor Function Measure-88
Time frame: 4-6 years
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 29 Aug 2023.
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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.
Ozge KARANLIK principal investigator
Marmara University
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 Cerebral Palsy and Developmental Coordination Disorder, run by Marmara University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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 29 Aug 2023. 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 Turkey (Türkiye). 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?
Developmental Coordination Disorder Questionnaire (time frame: 4-6 years). 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 29 Aug 2023.