NCT04277754

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

January 9, 2020

Last Update Submit

April 27, 2021

Conditions

Keywords

developmetmotorvisualinfant

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Visual acuity

    Up to two weeks

  • Visual axis alignment

    Up to two weeks

  • Three dimensional vision capability

    Up to two weeks

Study Arms (1)

two-year-old children with typical development

Other: Observational

Interventions

To Observe and describe motor and visual development

two-year-old children with typical development

Eligibility Criteria

Age24 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

two-year-old children with typical development

You may qualify if:

  • typical development
  • be enrolled in a nursery school of the University of Seville

You may not qualify if:

  • visual deficit
  • developmental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elena Piñero Pinto

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Motor Skills DisordersVision Disorders

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 9, 2020

First Posted

February 20, 2020

Study Start

January 2, 2020

Primary Completion

February 20, 2020

Study Completion

February 28, 2020

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations