- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02719600
Motor Learning Through Virtual Reality Task in Individuals With Down Syndrome
March 24, 2016 updated by: Carlos Bandeira de Mello Monteiro, University of Sao Paulo
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 28 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Down Syndrome Group
Group with Down Syndrome
|
Evaluation of observational motor learning using virtual reality
|
Active Comparator: Typical Development Group
Control group with typical development
|
Evaluation of observational motor learning using virtual reality
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor Learning test by using a timing coincident task in virtual reality
Time Frame: four months
|
Improvement on their performance, by reaching the task with precision
|
four months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carlos B Monteiro, PhD., University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
March 3, 2016
First Submitted That Met QC Criteria
March 24, 2016
First Posted (Estimate)
March 25, 2016
Study Record Updates
Last Update Posted (Estimate)
March 25, 2016
Last Update Submitted That Met QC Criteria
March 24, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1033/03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No interest on sharing individual participant data
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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