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.
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
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 group | Role | What they receive |
|---|---|---|
| Cerebral Palsy - Kinect | Experimental | Group with Cerebral Palsy that will perform the task on Kinect Receives: Device: Cerebral Palsy - Kinect |
| Cerebral Palsy - Touchscreen | Experimental | Group with Cerebral Palsy that will perform the task on Touchscreen Receives: Device: Cerebral Palsy - Touchscreen |
| Control Group - Kinect | Active comparator | Group with typical development that will perform the task on Kinect Receives: Device: Control Group - Kinect |
| Control Group - Touchscreen | Active comparator | Group 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.
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.
- First posted24 Nov 2017
- Study start20 Jan 2017
- Primary completion1 Oct 2017
- Study completion1 Dec 2017
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 Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 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, PhD, Principal investigator, University of Sao Paulo
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
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Different Devices Through Virtual Reality in People With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03352440
- Acronym / sponsor ID
- 32476414.5.0000.0082
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Virtual Reality Exposure Therapy, Learning, Motor Activity, Motor Skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 24 Nov 2017 (actual)
- 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.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cerebral Palsy - Kinect | Experimental | Device: Cerebral Palsy - KinectGroup with Cerebral Palsy that will perform the task on Kinect |
| Cerebral Palsy - Touchscreen | Experimental | Device: Cerebral Palsy - TouchscreenGroup with Cerebral Palsy that will perform the task on Touchscreen |
| Control Group - Kinect | Active comparator | Device: Control Group - KinectGroup with typical development that will perform the task on Kinect |
| Control Group - Touchscreen | Active comparator | Device: Control Group - TouchscreenGroup with typical development that will perform the task on Touchscreen |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Cerebral Palsy - KinectGroup with Cerebral Palsy that will perform the task on Kinect | Device | Cerebral Palsy - Kinect |
| Cerebral Palsy - TouchscreenGroup with Cerebral Palsy that will perform the task on Touchscreen | Device | Cerebral Palsy - Touchscreen |
| Control Group - KinectGroup with typical development that will perform the task on Kinect | Device | Control Group - Kinect |
| Control Group - TouchscreenGroup with typical development that will perform the task on Touchscreen | Device | Control Group - Touchscreen |
Primary outcome
Improvement of performance on Touchscreen interface provided by the Kinect system.
Time frame: one day
The number of bubbles reached with the attempts will show the improvement of performance.
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 2 May 2018.
- Derived from this study: PubMed 32349752Leal 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.
- 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, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
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.