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Analysis of a Virtual Reality Task in Patients With Duchenne Muscular Dystrophy

Primary Purpose

Duchenne Muscular Dystrophy

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Acquisition on TouchScreen
Acquisition on Kinect
Acquisition on LeapMotion
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Duchenne Muscular Dystrophy focused on measuring Duchenne muscular dystrophy, motor learning, motor abilities

Eligibility Criteria

9 Years - 34 Years (Child, Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • diagnosis of DMD.

Exclusion Criteria:

  • presence disorders in cognitive function that would prevent comprehension of the experimental instruction.

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 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Acquisition on TouchScreen

Acquisition on Kinect

Acquisition on LeapMotion

Acquisition on TouchScreen Control Group

Acquisition on Kinect Control Group

Acquisition on LeapMotion Control Group

Arm Description

Subjects practice the task and retention TouchScreen, transfer 1 on LeapMotion and transfer 2 on Kinect

Subjects practice the task and retention Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.

Subjects practice the task and retention LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.

Subjects practice the task and retention TouchScreen, transfer 1 on LeapMotion and transfer 2 on Kinect

Subjects practice the task and retention Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.

Subjects practice the task and retention LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.

Outcomes

Primary Outcome Measures

Motor performance improvement in a virtual Timing Coincident task, with better performance on the LeapMotion compared to TouchScreen and Kinect.
Analysis of the motor performance using a virtual Coincident timing task in different devices to compare wether a task with or without contact promote better performance for people with Duchenne Muscular Dystrophy

Secondary Outcome Measures

Full Information

First Posted
August 17, 2016
Last Updated
April 8, 2017
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02891434
Brief Title
Analysis of a Virtual Reality Task in Patients With Duchenne Muscular Dystrophy
Official Title
Analysis of Interaction of Different Devices in a Virtual Reality Task in Patients With Duchenne Muscular Dystrophy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The task consists in reach as much bubbles as they can, the bubbles appear on the screen of the computer and should be reached in 10 seconds. To accomplish that, three different devices will be used: (1) Kinect for Windows Microsoft - which consists of a sensor that captures body movements (including upper limbs). And (2) the Leap Motion (LMCH, Leap Motion, Inc., San Francisco, CA, USA), and (3) Touch Screen. To describe motor impairments was used the Motor Function Measure Scale; Scale Vignos and Scale Egen Klassifikation;
Detailed Description
To evaluate the performance of interaction devices was used a computer game proposed by the Department of Information Systems, University of São Paulo. Chosen due to its low cognitive demands, ease and adaptability for use in people with DMD. The program, offers a task designed to measure various neuropsychological aspects of planning, execution, spatial organization, which involves the operation of the intention to move to achieve a virtual object and the planning of this action. Considering different interfaces, opted for three interfaces. Two of theme without physical contact, represented by (1) Kinect for Windows Microsoft - which consists of a sensor that captures body movements (including upper limbs). And (2) the Leap Motion (LMCH, Leap Motion, Inc., San Francisco, CA, USA) - virtual interface by means of a sensor, in which there is also no need to touch or physical contact , but its catchment area is focused only on hands and fingers. In addition, an interface that required physical contact -Touch Screen - a sensitive monitor to touch the computer screen itself. The use of interfaces with and without physical contact are interesting to identify the functionality of the devices. Therefore, the game presented 126 bubbles arranged in rows and columns . The goal was that the participant could achieve (changing color) the largest number of bubbles during 10 seconds, thereby defining a range zone for the specified time. After defining the scope zone, the therapist established a red target bubble, which was chosen in the center of bottom of range line. The participant should play this target bubble using one of the devices, Touch Screen, Kinect and Leap Motion. After touch of target bubble, the game had another red bubble in a random position, within range of area. After reaching the random bubble, the bubble target was displayed again, and so on. The game features red bubbles within the range area, and sometimes out of range, thus creating a higher degree of difficulty and to encourage participants to challenge their limits. The Participants were divided into groups which performed the tasks with different interaction devices, more virtual feature (not touch the computer using Kinect or leap motion) or real (to touch the computer screen).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duchenne Muscular Dystrophy
Keywords
Duchenne muscular dystrophy, motor learning, motor abilities

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acquisition on TouchScreen
Arm Type
Experimental
Arm Description
Subjects practice the task and retention TouchScreen, transfer 1 on LeapMotion and transfer 2 on Kinect
Arm Title
Acquisition on Kinect
Arm Type
Experimental
Arm Description
Subjects practice the task and retention Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
Arm Title
Acquisition on LeapMotion
Arm Type
Experimental
Arm Description
Subjects practice the task and retention LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.
Arm Title
Acquisition on TouchScreen Control Group
Arm Type
Active Comparator
Arm Description
Subjects practice the task and retention TouchScreen, transfer 1 on LeapMotion and transfer 2 on Kinect
Arm Title
Acquisition on Kinect Control Group
Arm Type
Active Comparator
Arm Description
Subjects practice the task and retention Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
Arm Title
Acquisition on LeapMotion Control Group
Arm Type
Active Comparator
Arm Description
Subjects practice the task and retention LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.
Intervention Type
Device
Intervention Name(s)
Acquisition on TouchScreen
Intervention Description
Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.
Intervention Type
Device
Intervention Name(s)
Acquisition on Kinect
Intervention Description
Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
Intervention Type
Device
Intervention Name(s)
Acquisition on LeapMotion
Intervention Description
Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.
Primary Outcome Measure Information:
Title
Motor performance improvement in a virtual Timing Coincident task, with better performance on the LeapMotion compared to TouchScreen and Kinect.
Description
Analysis of the motor performance using a virtual Coincident timing task in different devices to compare wether a task with or without contact promote better performance for people with Duchenne Muscular Dystrophy
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diagnosis of DMD. Exclusion Criteria: presence disorders in cognitive function that would prevent comprehension of the experimental instruction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos BM Monteiro, Ph.D.
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
State/Province
SP
ZIP/Postal Code
03828-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30761066
Citation
de Freitas BL, da Silva TD, Crocetta TB, Massetti T, de Araujo LV, Coe S, Dawes H, Caromano FA, Monteiro CBM. Analysis of Different Device Interactions in a Virtual Reality Task in Individuals With Duchenne Muscular Dystrophy-A Randomized Controlled Trial. Front Neurol. 2019 Jan 29;10:24. doi: 10.3389/fneur.2019.00024. eCollection 2019.
Results Reference
derived

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Analysis of a Virtual Reality Task in Patients With Duchenne Muscular Dystrophy

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