NCT02719600

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

March 3, 2016

Last Update Submit

March 24, 2016

Conditions

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (1)

  • Motor Learning test by using a timing coincident task in virtual reality

    Improvement on their performance, by reaching the task with precision

    four months

Study Arms (2)

Down Syndrome Group

EXPERIMENTAL

Group with Down Syndrome

Behavioral: Virtual reality

Typical Development Group

ACTIVE COMPARATOR

Control group with typical development

Behavioral: Virtual reality

Interventions

Virtual realityBEHAVIORAL

Evaluation of observational motor learning using virtual reality

Down Syndrome GroupTypical Development Group

Eligibility Criteria

Age11 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • de Mello Monteiro CB, da Silva TD, de Abreu LC, Fregni F, de Araujo LV, Ferreira FHIB, Leone C. Short-term motor learning through non-immersive virtual reality task in individuals with down syndrome. BMC Neurol. 2017 Apr 14;17(1):71. doi: 10.1186/s12883-017-0852-z.

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Carlos B Monteiro, PhD.

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 25, 2016

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 25, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

No interest on sharing individual participant data