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Cerebral PalsyNCT03352440

Different Virtual Reality Devices in People With Cerebral Palsy

A study testing Cerebral Palsy - Kinect and Cerebral Palsy - Touchscreen in people with Cerebral Palsy, run by University of Sao Paulo at 1 site in Brazil.

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

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. Read more about this study

Who is it for?
Ages 6 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Cerebral Palsy
What is being tested?
Cerebral Palsy - Kinect and Cerebral Palsy - Touchscreen
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteBrazil
Study dates
20 Jan 2017to 1 Dec 2017
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 6 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • individuals with a diagnosis PC (for the experimental group);
  • diparesis and spastic hemiparesis;
  • with gross motor function classification as levels I, II and III according to the Gross Motor Function Classification System (GMFCS).

Who cannot join

  • individuals who have undergone surgery or performing chemical neuromuscular blockade for less than 6 months in the upper limbs;
  • associated diseases;
  • changes in cognitive functions that preclude cooperation and understanding in the proposed activities.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo

    São Paulo, 03828-000

Other trials in Brazil

About this study

Official title: The Use of Different Devices Through Virtual Reality in People With Cerebral Palsy

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.

Read the detailed description

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.

Conditions
Cerebral Palsy
Being tested
Cerebral Palsy - Kinect, Cerebral Palsy - Touchscreen, Control Group - Kinect, Control Group - Touchscreen
Keywords
Cerebral Palsy, Virtual Reality Exposure Therapy, Learning, Motor Activity, Motor Skills
Medical subject headings
Cerebral Palsy, Motor Activity

What participants receive

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

  • Cerebral Palsy - KinectDevice

    Group with Cerebral Palsy that will perform the task on Kinect

  • Cerebral Palsy - TouchscreenDevice

    Group with Cerebral Palsy that will perform the task on Touchscreen

  • Control Group - KinectDevice

    Group with typical development that will perform the task on Kinect

  • Control Group - TouchscreenDevice

    Group with typical development that will perform the task on Touchscreen

Study groups in NCT03352440
Study groupRoleWhat they receive
Cerebral Palsy - KinectExperimentalGroup with Cerebral Palsy that will perform the task on Kinect
Receives: Device: Cerebral Palsy - Kinect
Cerebral Palsy - TouchscreenExperimentalGroup with Cerebral Palsy that will perform the task on Touchscreen
Receives: Device: Cerebral Palsy - Touchscreen
Control Group - KinectActive comparatorGroup with typical development that will perform the task on Kinect
Receives: Device: Control Group - Kinect
Control Group - TouchscreenActive comparatorGroup with typical development that will perform the task on Touchscreen
Receives: Device: Control Group - Touchscreen

What is being measured

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

  1. 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.

    Measured: one day

Timeline

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

  1. First posted24 Nov 2017
  2. Study start20 Jan 2017
  3. Primary completion1 Oct 2017
  4. Study completion1 Dec 2017

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03352440
Sponsor's protocol ID
32476414.5.0000.0082
Status last verified
Apr 2018
First submitted
17 Nov 2017
Last updated
2 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Leal AF, da Silva TD, Lopes PB, Bahadori S, de Araujo LV, da Costa MVB, de Moraes IAP, Marques RH, Crocetta TB, de Abreu LC, Monteiro CBM. The use of a task through virtual reality in cerebral palsy using two different interaction devices (concrete and abstract) - a cross-sectional randomized study. J Neuroeng Rehabil. 2020 Apr 29;17(1):59. doi: 10.1186/s12984-020-00689-z.

    PubMed 32349752

Questions about this trial

What is this clinical trial studying?

A study testing Cerebral Palsy - Kinect and Cerebral Palsy - Touchscreen in people with Cerebral Palsy, run by University of Sao Paulo at 1 site in Brazil.

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 3 inclusion and 3 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 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Improvement of performance on Touchscreen interface provided by the Kinect system. (time frame: one day). 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 NCT03352440, 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 2 May 2018.

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