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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02719600
Other study ID # 1033/03
Secondary ID
Status Completed
Phase N/A
First received March 3, 2016
Last updated March 24, 2016
Start date March 2015
Est. completion date March 2016

Study information

Verified date March 2016
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

Background: Down syndrome (DS) has unique physical, motor and cognitive characteristics. Despite cognitive and motor difficulties, there is a possibility of intervention based on the knowledge of motor learning. However, it is important to study the motor learning process in individuals with DS during a virtual reality task to justify the use of virtual reality to organize intervention programs. The aim of this study was to analyze the motor learning process in individuals with DS during a virtual reality task. Methods: A total of 40 individuals participated in this study, 20 of which were with DS (24 males and 8 females, ranging between 11-28 yrs.) and 20 typically developing individuals matched by age and gender to the individuals with DS. To examine this issue, we used software that uses 3D images and reproduced a coincidence timing task.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Years to 28 Years
Eligibility Inclusion Criteria:

- medical diagnosis of DS and the ability to understand the task.

Exclusion Criteria:

- disorders in cognitive function that would prevent comprehension of the experimental instruction

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual reality
Evaluation of observational motor learning using virtual reality

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Outcome

Type Measure Description Time frame Safety issue
Primary Motor Learning test by using a timing coincident task in virtual reality Improvement on their performance, by reaching the task with precision four months No
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