Different Virtual Reality Devices in People With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cerebral Palsy - Kinect
Cerebral Palsy - Touchscreen
Control Group - Kinect
Control Group - Touchscreen
Sponsored by
About this trial
This is an interventional other trial for Cerebral Palsy focused on measuring Cerebral Palsy, Virtual Reality Exposure Therapy, Learning, Motor Activity, Motor Skills
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Sites / Locations
- Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Cerebral Palsy - Kinect
Cerebral Palsy - Touchscreen
Control Group - Kinect
Control Group - Touchscreen
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03352440
First Posted
November 17, 2017
Last Updated
April 30, 2018
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03352440
Brief Title
Different Virtual Reality Devices in People With Cerebral Palsy
Official Title
The Use of Different Devices Through Virtual Reality in People With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 20, 2017 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy, Virtual Reality Exposure Therapy, Learning, Motor Activity, Motor Skills
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cerebral Palsy - Kinect
Arm Type
Experimental
Arm Description
Group with Cerebral Palsy that will perform the task on Kinect
Arm Title
Cerebral Palsy - Touchscreen
Arm Type
Experimental
Arm Description
Group with Cerebral Palsy that will perform the task on Touchscreen
Arm Title
Control Group - Kinect
Arm Type
Active Comparator
Arm Description
Group with typical development that will perform the task on Kinect
Arm Title
Control Group - Touchscreen
Arm Type
Active Comparator
Arm Description
Group with typical development that will perform the task on Touchscreen
Intervention Type
Device
Intervention Name(s)
Cerebral Palsy - Kinect
Intervention Description
Group with Cerebral Palsy that will perform the task on Kinect
Intervention Type
Device
Intervention Name(s)
Cerebral Palsy - Touchscreen
Intervention Description
Group with Cerebral Palsy that will perform the task on Touchscreen
Intervention Type
Device
Intervention Name(s)
Control Group - Kinect
Intervention Description
Group with typical development that will perform the task on Kinect
Intervention Type
Device
Intervention Name(s)
Control Group - Touchscreen
Intervention Description
Group with typical development that will perform the task on Touchscreen
Primary Outcome Measure Information:
Title
Improvement of performance on Touchscreen interface provided by the Kinect system.
Description
The number of bubbles reached with the attempts will show the improvement of performance.
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos BM Monteiro, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo
City
Sao Paulo
ZIP/Postal Code
03828-000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32349752
Citation
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.
Results Reference
derived
Learn more about this trial
Different Virtual Reality Devices in People With Cerebral Palsy
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