Development, ChildNCT04277754
Motor and Visual Development in 2 Year Olds
An observational study of Development, Child and Motor Skills Disorders, run by University of Seville at 1 site in Spain.
Trial summary
It is a study where investigators are going to measure variables related to motor development and vision through objective tests in children with typical development of two years of age. Read more about this study
- Who is it for?
- Ages 24 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Development, Child, Motor Skills Disorders, Visual Disorder
- What is being tested?
- Observational
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jan 2020to 28 Feb 2020
- 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 24 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: two-year-old children with typical development
Who may be able to join
- typical development
- be enrolled in a nursery school of the University of Seville
Who cannot join
- visual deficit
- developmental disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correspondence Between Motor and Road Development in 2-year-old Children With Typical Development
It is a study where investigators are going to measure variables related to motor development and vision through objective tests in children with typical development of two years of age.
- Conditions
- Development, Child, Motor Skills Disorders, Visual Disorder
- Being tested
- Observational
- Keywords
- developmet, motor, visual, infant
- Medical subject headings
- Motor Skills Disorders, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
To Observe and describe motor and visual development
| Study group | Role | What they receive |
|---|---|---|
| two-year-old children with typical development | Not described Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor development
Researchers will use objective tests to measure the equivalent age of development in this area with respect to their chronological age and the percentage of skills acquired in the different dimensions of the motor area.
The evidence that will be used will be for this purpose will be:
- Peabody Developmental Motor Scales- II.
It will take about 15 minutes of evaluation where the child will be asked to reproduce a series of general body movements, as well as some hand and object skills
Measured: Up to two weeks
Motor development
Researchers will use objective tests to measure the coefficients of development in this area with respect to their chronological age and the percentage of skills acquired in the different dimensions of the motor area.
The evidence that will be used will be for this purpose will be:
- Peabody Developmental Motor Scales- II.
It will take about 15 minutes of evaluation where the child will be asked to reproduce a series of general body movements, as well as some hand and object skills
Measured: Up to two weeks
Secondary outcomes (3)
Visual acuity
Researchers will check visual acuity through the Cardif Test. It is non-invasive and the collaboration required by the child is minimal.
Measured: Up to two weeks
Visual axis alignment
Researchers will check visual axis alignment throught the Cover Test. It Is non-invasive and the collaboration required by the child is minimal.
Measured: Up to two weeks
Three dimensional vision capability
Researchers will check three-dimensional vision capability throught the Lang Test. It is non-invasive and the collaboration required by the child is minimal.
Measured: Up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start2 Jan 2020
- Primary completion20 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development, ChildStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Piñero Pinto, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277754
- Sponsor's protocol ID
- Development
- Status last verified
- Apr 2021
- First submitted
- 9 Jan 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correspondence Between Motor and Road Development in 2-year-old Children With Typical Development
- ClinicalTrials.gov ID
- NCT04277754
- Acronym / sponsor ID
- Development
- Conditions
- Development, Child, Motor Skills Disorders, Visual Disorder
- Keywords
- developmet, motor, visual, infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 20 Feb 2020 (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.
It is a study where investigators are going to measure variables related to motor development and vision through objective tests in children with typical development of two years of age.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| two-year-old children with typical development | – | Other: Observational |
Who may qualify
- Ages
- 24 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- two-year-old children with typical development
Key inclusion criteria (2 listed)
- typical development
- be enrolled in a nursery school of the University of Seville
Key exclusion criteria (2 listed)
- visual deficit
- developmental disorder
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 |
|---|---|---|
| ObservationalTo Observe and describe motor and visual development | Other | two-year-old children with typical development |
Primary outcome
Motor development
Time frame: Up to two weeks
Researchers will use objective tests to measure the equivalent age of development in this area with respect to their chronological age and the percentage of skills acquired in the different dimensions of the motor area. The evidence that will be used will be for this purpose will be: - Peabody Developmental Motor Scales- II. It will take about 15 minutes of evaluation where the child will be asked to reproduce a series of general body movements, as well as some hand and object skills
Motor development
Time frame: Up to two weeks
Researchers will use objective tests to measure the coefficients of development in this area with respect to their chronological age and the percentage of skills acquired in the different dimensions of the motor area. The evidence that will be used will be for this purpose will be: - Peabody Developmental Motor Scales- II. It will take about 15 minutes of evaluation where the child will be asked to reproduce a series of general body movements, as well as some hand and object skills
3 secondary outcomes
Visual acuity
Time frame: Up to two weeks
Visual axis alignment
Time frame: Up to two weeks
Three dimensional vision capability
Time frame: Up to two weeks
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 28 Apr 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Development, Child and Motor Skills Disorders, run by University of Seville at 1 site in Spain.
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 28 Apr 2021. 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 Spain. 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?
Motor development (time frame: Up to two weeks). The study lists 2 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 28 Apr 2021.