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Duchenne Muscular DystrophyNCT03002298

Virtual Reality in Individuals With Duchenne Muscular Dystrophy

A study testing DMD gesture task and DMD button-press task in people with Duchenne Muscular Dystrophy, run by University of Sao Paulo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

With the growing accessibility of computer-assisted technology, one option for rehabilitation programs for individuals with Duchenne muscular dystrophy (DMD) is the use of virtual reality environments to enhance motor practice. Read more about this study

Who is it for?
Ages 12 to 32 years, men onlyHealthy volunteers can take part
Conditions the study is for
Duchenne Muscular Dystrophy
What is being tested?
DMD gesture task and DMD button-press task
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
No sites listed yet
Study dates
Jan 2016to Oct 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 12 to 32 years
  • Men only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • medical diagnosis of Duchenne Muscular Dystrophy confirmed by molecular method and/or protein expression in skeletal muscle;
  • signing of an informed consent form from the individual or person legally responsible.

Who cannot join

  • presence of associated comorbidities;
  • inability in comprehension of the task.

About this study

Official title: Motor Learning From Virtual to Natural Environments in Individuals With Duchenne Muscular Dystrophy

With the growing accessibility of computer-assisted technology, one option for rehabilitation programs for individuals with Duchenne muscular dystrophy (DMD) is the use of virtual reality environments to enhance motor practice. Thus, it is important to examine whether performance improvements in the virtual environment generalize to the natural environment. To examine this issue, we had 64 individuals, 32 of which were individuals with DMD and 32 were typically developing individuals. The groups practiced two coincidence timing tasks. In the more tangible button-press task, the individuals were required to 'intercept' a falling virtual object at the moment it reached the interception point by pressing a key on the computer. In the more abstract task, they were instructed to 'intercept' the virtual object by making a hand movement in a virtual environment using a webcam.

Read the detailed description

The Department of Electronic System Engineering of the Polytechnic School of the University of São Paulo (Brazil) developed the software that superimposes virtual objects over images of real world, captured with a webcam.

The coincidence timing task could either have a virtual or a real interface. For the real interface, a keyboard was used. For the virtual interface, a webcam recorded a marker on the table alongside the keyboard of the computer. The images were fed into the computer and analyzed online. Using the custom-made software, it was determined whether or not the participant's hand occluded the marker, which was then fed back to the virtual environment. The coincidence timing task was based on the Bassin Anticipation Timer. To this end, 10 3D-cubes were displayed simultaneously in a vertical column on a monitor. The cubes were turned on (i.e., they changed from white to green) and off sequentially (from top to bottom) until the target cube (i.e., the tenth cube) was reached. The task for the participant was to either press the space bar on the keyboard (i.e., tangible button press task, by physical contact, represented on figure 1A and 1B) or to make a sideward hand gesture as if hitting the target object (i.e., the more abstract gesture task, with no physical contact, represented on the figure 1C and 1D), i.e., occluding the marker at the exact moment the target cube turned green.

Participants performed the task individually in a quiet room with only the examiner who gave the instructions present. The computer was placed on a table. The participants were seated in their wheelchair, which was adjusted according to the needs of the individual.

The examiner explained the task verbally and gave three demonstrations of how to perform the coincidence timing tasks. The participants were instructed to place the preferred hand (i.e., the less affected hand) on a mark aside to the target (The location was individually adjusted but ranged from 2 to 4 cm from the target). Once the first top cube turned on, the individual had to move his hand to either touch the target key on the keyboard or to make a hitting gesture in front of the webcam, exactly at the moment coinciding with the bottom target cube turning on. Different sounds were provided as feedback for either a hit or miss during acquisition, retention and transfer, the range of error being -200 to 200ms.

Participants with DMD and TD were divided into two subgroups randomly: (a) button-press task group (BPT) - in this group during the acquisition phase the participants should press the space button on keyboard to complete the coincidence timing task (more real interface) and (b) gesture task group (GT) - in this group during the acquisition phase the participants should cross a virtual target created by a webcam to complete the coincidence timing task instead of press the computer button (more virtual interface).

For all tasks (button-press and gesture), during the acquisition phase, all groups started performing 20 attempts of the coincidence timing task and, after five minutes with no contact with the task, they performed five more repetitions for the retention phase (both phases in slower speed - with the turning on and off of the lights in an interval of 400ms), finally they performed five repetitions for two different transfers phases: the first transfer was performed with a faster speed - 300ms of lights interval (transfer with speed increase - TSI). The second transfer was performed with change task (transfer with exchange of en vironment - TEE) between groups by doing 5 attempts transfer phase in another interface. It means, the group that has done the acquisition phase in button-press task performed the transfer on gesture task and vice versa.

Being tested
DMD gesture task, DMD button-press task, Control group gesture task, Control group button-press task
Medical subject headings
Muscular Dystrophy, Duchenne

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DMD gesture taskBehavioural

    Timing coincident task in a virtual environment, using motor learning protocol in which a gesture in front of a webcam shoub be done to reach the task

  • DMD button-press taskBehavioural

    Timing coincident task in a virtual environment, using motor learning protocol in which the task shoub be done by pressing a button on the keyboard

  • Control group gesture taskBehavioural

    Timing coincident task in a virtual environment, using motor learning protocol in which a gesture in front of a webcam shoub be done to reach the task

  • Control group button-press taskBehavioural

    Timing coincident task in a virtual environment, using motor learning protocol in which the task shoub be done by pressing a button on the keyboard

Study groups in NCT03002298
Study groupRoleWhat they receive
DMD gesture taskExperimentalExperimental group that made the task using a gesture in front of a webcam
Receives: Behavioral: DMD gesture task
DMD button-press taskExperimentalExperimental group that made the task pressing the button
Receives: Behavioral: DMD button-press task
Control group gesture taskActive comparatorControl group that made the task using a gesture in front of a webcam
Receives: Behavioral: Control group gesture task
Control group button-press taskActive comparatorControl group that made the task pressing the button
Receives: Behavioral: Control group button-press task

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionAug 2016
  4. Study completionOct 2016

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03002298
Sponsor's protocol ID
16796513.1.0000.0065
Status last verified
Apr 2017
First submitted
19 Dec 2016
Last updated
11 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing DMD gesture task and DMD button-press task in people with Duchenne Muscular Dystrophy, 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 2 inclusion and 2 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 11 Apr 2017. 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: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 11 Apr 2017.

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