Motor and Visual Development in 2 Year Olds

• Sponsor: University of Seville (Other)
• Overall Status: Completed
• CT.gov ID: NCT04277754
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 1.9
• Patients Per Site Per Month: 53.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Development, Child; Motor Skills Disorders; Visual Disorder	Other: Observational

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Ecologic or Community
• Time Perspective: Prospective
• Official Title: Correspondence Between Motor and Road Development in 2-year-old Children With Typical Development
• Actual Study Start Date: Jan 2, 2020
• Actual Primary Completion Date: Feb 20, 2020
• Actual Study Completion Date: Feb 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
two-year-old children with typical development	Other: Observational; To Observe and describe motor and visual development

Outcome Measures

Primary Outcome Measures

1. Motor development [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

2. Motor development [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

Secondary Outcome Measures

1. Visual acuity [Up to two weeks]

   Researchers will check visual acuity through the Cardif Test. It is non-invasive and the collaboration required by the child is minimal.

2. Visual axis alignment [Up to two weeks]

   Researchers will check visual axis alignment throught the Cover Test. It Is non-invasive and the collaboration required by the child is minimal.

3. Three dimensional vision capability [Up to two weeks]

   Researchers will check three-dimensional vision capability throught the Lang Test. It is non-invasive and the collaboration required by the child is minimal.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 24 Months to 36 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• typical development

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

Exclusion Criteria:

• visual deficit

• developmental disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Elena Piñero Pinto	Sevilla		Spain	41013

Sponsors and Collaborators

• University of Seville

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elena Piñero Pinto, Principal investigator, University of Seville
• ClinicalTrials.gov Identifier: NCT04277754
• Other Study ID Numbers: Development
• First Posted: Feb 20, 2020
• Last Update Posted: Apr 28, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Elena Piñero Pinto, Principal investigator, University of Seville: developmet; motor; visual; infant
• Additional relevant MeSH terms: Vision Disorders; Disease; Motor Skills Disorders

Study Results

No Results Posted as of Apr 28, 2021