Down SyndromeNCT02719600
Motor Learning Through Virtual Reality Task in Individuals With Down Syndrome
A study testing Virtual reality in people with Down Syndrome, run by University of Sao Paulo.
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. Read more about this study
- Who is it for?
- Ages 11 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Virtual reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 28 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- medical diagnosis of DS and the ability to understand the task.
Who cannot join
- disorders in cognitive function that would prevent comprehension of the experimental instruction
About this study
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.
- Conditions
- Down Syndrome
- Being tested
- Virtual reality
- Keywords
- Virtual Reality
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityBehavioural
Evaluation of observational motor learning using virtual reality
| Study group | Role | What they receive |
|---|---|---|
| Down Syndrome Group | Experimental | Group with Down Syndrome Receives: Behavioral: Virtual reality |
| Typical Development Group | Active comparator | Control group with typical development Receives: Behavioral: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Learning test by using a timing coincident task in virtual reality
Improvement on their performance, by reaching the task with precision
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Bandeira de Mello Monteiro, University of Sao Paulo
- Investigators
- Carlos B Monteiro, PhD., Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719600
- Sponsor's protocol ID
- 1033/03
- Status last verified
- Mar 2016
- First submitted
- 3 Mar 2016
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No interest on sharing individual participant data
Publications
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.
PubMed 28410583
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Learning Through Virtual Reality Task in Individuals With Down Syndrome
- ClinicalTrials.gov ID
- NCT02719600
- Acronym / sponsor ID
- 1033/03
- Conditions
- Down Syndrome
- Keywords
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Down Syndrome Group | Experimental | Behavioral: Virtual realityGroup with Down Syndrome |
| Typical Development Group | Active comparator | Behavioral: Virtual realityControl group with typical development |
Who may qualify
- Ages
- 11 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- medical diagnosis of DS and the ability to understand the task.
Key exclusion criteria (1 listed)
- disorders in cognitive function that would prevent comprehension of the experimental instruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityEvaluation of observational motor learning using virtual reality | Behavioural | Down Syndrome Group, Typical Development Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Derived from this study: PubMed 28410583de 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.
- Individual participant dataSharing planned: No. No interest on sharing individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos B Monteiro, PhD. principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Down Syndrome, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Learning test by using a timing coincident task in virtual reality (time frame: four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02719600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.