An interventional study of Cerebral Palsy - Kinect and Cerebral Palsy - Touchscreen in Cerebral Palsy, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 6 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-02.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Other
Among 21 studies in Cerebral Palsy with a site in Brazil — 2 open to participants now, 2 under way, none of them phase 3. Cerebral Palsy · Brazil.
Among the 21 studies in Cerebral Palsy with a site in Brazil, this one is the 5th largest by enrollment of the 18 interventional ones that give a count, is one of 2 that started in 2017, is one of 16 with no phase, and was the 10th registered.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
Browse Cerebral Palsy studies →2 of the 21 studies in Cerebral Palsy with a site in Brazil are open now. Recruiting first, the newest first:
Universidade Federal de Sao Carlos · Sites in Brazil
Fernanda Trubian · Sites in Brazil
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 270 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 235 (87%) stop at 75 or younger; 255 take children under 18; 51 take healthy volunteers.
This study: 6 Years to 15 Years · all sexes · healthy volunteers too.
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21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 1 · Phase 3 2
First in 2005; this study’s year is marked. 2 started in 2017.
This study's enrollment of 57 is above the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Median enrollment 30 across the 18 interventional studies, 30 across the 3 observational. Of the 13 that completed or were terminated, 0 (0%) have results posted.
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1 of 21 have an industry lead sponsor. The 10 most frequent:
University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
University of Sao Paulo has 4 studies filed under Cerebral Palsy — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 21 studies in Cerebral Palsy with a site in Brazil, from their registry updates:
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A computer program was developed with the same task, but with two possibilities of user interaction: a) interface with contact: in which the individual touches the computer screen to finish the task and b) interface without contact: in which the individual perform a hand movement in front of the Kinect. Were evaluated 29 individuals with CP who constituted the experimental group and 28 individuals without deficiency who composed the control group with matching age and sex.
A total of 57 individuals were included in this study, 29 individuals with CP who constituted the experimental group and 28 individuals without deficiency, aged between 6 and 15 years, with understanding of the task to be performed. Of these, 14 formed the experimental group 1 that performed the task on Kinect (CP-Group1) and 15 individuals formed the control group 1 (TD-Group1), 15 formed the experimental group 2 (CP-Group2) and 13 individuals formed the control group 2 (TD-Group2), all control groups matched for age and sex with the experimental group 1 and 2, all without any disability.
All individuals with CP who were evaluated manage to stay well seated to function in the upper limbs and have independent walking even necessary aid walker or crutches.
Material and Apparatus Software specialists developed a package of games, named Team Bridge Games, and for this study, was used the Check Limit Game. This game allows the use of a Kinect sensor for motion capture (without contact interface), as well as a touch screen (with contact interface). The virtual reality tool used was developed by the Information Systems Laboratory of EACH / USP which features on the computer a task in which several balls are on the screen and must be touched to change color. The goal is to change the maximum of balls color in 15 seconds. The touch is performed through the touch screen corresponding to the physical environment with tap or by means of touchless environment using a virtual interface offered by Kinect system. Data regarding performance will be analyzed considering the number of hit balls.
Procedure and Design To perform the task virtual research participants will be positioned at the computer so that they are adjusted in height (this will depend on the physical composition of each participant) and away from the computer screen, approximately 1.5m., and also the interface used thus enabling the beginning of the task.
It were previously explained to the participant as it should do it with the Kinect, which through actual movement the individual has the ability to perform a task, using an avatar, each with their specific implementation, with one of the upper limbs and fingers of one hand respectively; should be aware of the start of the task as the verbal command of the researcher, for each phase of the task to be performed has duration of 7 minutes and 30 seconds, 1 minute and 15 seconds respectively, with five-minute interval, consisting of the acquisition phase ( the activity will be repeated 30 times / attempts), retention (will repeat the activity 5 times / attempts) and transfer (activity will be repeated 5 times / attempts) respectively.
Considering an estimated running time of approximately 30 minutes in just one meeting. Both the experimental group and the control group performed two tasks: real and virtual environment, where the control and experimental group-1 performed the following sequence: Acquisition = Kinect, Retention = Kinect and Transfer = Touchscreen; the experimental control group-2 and performed the following sequence: Acquisition = Touchscreen, Retention = Touchscreen and Transfer = Kinect.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Group with Cerebral Palsy that will perform the task on Kinect
Device: Cerebral Palsy - Kinect
Group with Cerebral Palsy that will perform the task on Touchscreen
Device: Cerebral Palsy - Touchscreen
Group with typical development that will perform the task on Kinect
Device: Control Group - Kinect
Group with typical development that will perform the task on Touchscreen
Device: Control Group - Touchscreen
Group with Cerebral Palsy that will perform the task on Kinect
Group with Cerebral Palsy that will perform the task on Touchscreen
Group with typical development that will perform the task on Kinect
Group with typical development that will perform the task on Touchscreen
Improvement of performance on Touchscreen interface provided by the Kinect system.
The number of bubbles reached with the attempts will show the improvement of performance.
Time frame: one day
Plan to share: Undecided
Ran from Jan 2017 to primary completion in Oct 2017, 8 months.
Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 8 months is below that.
Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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