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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04277754
Other study ID # Development
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2020
Est. completion date February 28, 2020

Study information

Verified date April 2021
Source University of Seville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date February 28, 2020
Est. primary completion date February 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 24 Months to 36 Months
Eligibility Inclusion Criteria: - typical development - be enrolled in a nursery school of the University of Seville Exclusion Criteria: - visual deficit - developmental disorder

Study Design


Intervention

Other:
Observational
To Observe and describe motor and visual development

Locations

Country Name City State
Spain Elena Piñero Pinto Sevilla

Sponsors (1)

Lead Sponsor Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Up to two weeks
Primary 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
Up to two weeks
Secondary Visual acuity Researchers will check visual acuity through the Cardif Test. It is non-invasive and the collaboration required by the child is minimal. Up to two weeks
Secondary 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. Up to two weeks
Secondary 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. Up to two weeks
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