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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
- Conditions
- Duchenne Muscular Dystrophy
- 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 group | Role | What they receive |
|---|---|---|
| DMD gesture task | Experimental | Experimental group that made the task using a gesture in front of a webcam Receives: Behavioral: DMD gesture task |
| DMD button-press task | Experimental | Experimental group that made the task pressing the button Receives: Behavioral: DMD button-press task |
| Control group gesture task | Active comparator | Control group that made the task using a gesture in front of a webcam Receives: Behavioral: Control group gesture task |
| Control group button-press task | Active comparator | Control 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.
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.
- First posted23 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 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 BM Monteiro, Ph.D., Principal investigator, University of Sao Paulo
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Learning From Virtual to Natural Environments in Individuals With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT03002298
- Acronym / sponsor ID
- 16796513.1.0000.0065
- Conditions
- Duchenne Muscular Dystrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 23 Dec 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DMD gesture task | Experimental | Behavioral: DMD gesture taskExperimental group that made the task using a gesture in front of a webcam |
| DMD button-press task | Experimental | Behavioral: DMD button-press taskExperimental group that made the task pressing the button |
| Control group gesture task | Active comparator | Behavioral: Control group gesture taskControl group that made the task using a gesture in front of a webcam |
| Control group button-press task | Active comparator | Behavioral: Control group button-press taskControl group that made the task pressing the button |
Who may qualify
- Ages
- 12 to 32 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- presence of associated comorbidities;
- inability in comprehension of the task.
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 |
|---|---|---|
| DMD gesture taskTiming 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 | Behavioural | DMD gesture task |
| DMD button-press taskTiming coincident task in a virtual environment, using motor learning protocol in which the task shoub be done by pressing a button on the keyboard | Behavioural | DMD button-press task |
| Control group gesture taskTiming 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 | Behavioural | Control group gesture task |
| Control group button-press taskTiming coincident task in a virtual environment, using motor learning protocol in which the task shoub be done by pressing a button on the keyboard | Behavioural | Control group button-press task |
Primary outcome
Motor Learning test by using a timing coincident task in virtual reality
Time frame: 1 day
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 11 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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 BM Monteiro, Ph.D. principal investigator
University of Sao Paulo
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.