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

Duchenne Muscular Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891434
• Other study ID #: 248/15
• Status: Completed
• Phase: N/A
• First received: August 17, 2016
• Last updated: April 8, 2017
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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;

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 9 Years to 34 Years

Eligibility

Inclusion Criteria:

• diagnosis of DMD.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Intervention

Device:
• Acquisition on TouchScreen
Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.
• Acquisition on Kinect
Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
• Acquisition on LeapMotion
Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.

Locations

Country	Name	City	State
Brazil	Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months