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

• ClinicalTrials.gov Identifier: NCT02891434
• Recruitment Status: Completed
• First Posted: September 7, 2016
• Last Update Posted: April 11, 2017
• Sponsor: University of Sao Paulo
• Information provided by (Responsible Party): Carlos Bandeira de Mello Monteiro, University of Sao Paulo

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;

Condition or disease	Intervention/treatment	Phase
Duchenne Muscular Dystrophy	Device: Acquisition on TouchScreen; Device: Acquisition on Kinect; Device: Acquisition on LeapMotion	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Analysis of Interaction of Different Devices in a Virtual Reality Task in Patients With Duchenne Muscular Dystrophy
• Actual Study Start Date: February 2016
• Actual Primary Completion Date: October 2016
• Actual Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Acquisition on TouchScreen; Subjects practice the task and retention TouchScreen, transfer 1 on LeapMotion and transfer 2 on Kinect	Device: Acquisition on TouchScreen; Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.
Experimental: Acquisition on Kinect; Subjects practice the task and retention Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.	Device: Acquisition on Kinect; Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
Experimental: Acquisition on LeapMotion; Subjects practice the task and retention LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.	Device: Acquisition on LeapMotion; Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.
Active Comparator: Acquisition on TouchScreen Control Group; Subjects practice the task and retention TouchScreen, transfer 1 on LeapMotion and transfer 2 on Kinect	Device: Acquisition on TouchScreen; Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.
Active Comparator: Acquisition on Kinect Control Group; Subjects practice the task and retention Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.	Device: Acquisition on Kinect; Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
Active Comparator: Acquisition on LeapMotion Control Group; Subjects practice the task and retention LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.	Device: Acquisition on LeapMotion; Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.

Outcome Measures

Primary Outcome Measures :

1. Motor performance improvement in a virtual Timing Coincident task, with better performance on the LeapMotion compared to TouchScreen and Kinect. [ Time Frame: 3 months ]
   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

Eligibility Criteria

• Ages Eligible for Study: 9 Years to 34 Years (Child, Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• diagnosis of DMD.

Exclusion Criteria:

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

Contacts and Locations

Locations

Brazil

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

Sao Paulo, SP, Brazil, 03828-000

Sponsors and Collaborators

University of Sao Paulo

Investigators

• Principal Investigator: Carlos BM Monteiro, Ph.D.; University of Sao Paulo

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

de Freitas BL, da Silva TD, Crocetta TB, Massetti T, de Araújo 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.

• Responsible Party: Carlos Bandeira de Mello Monteiro, Associate Professor, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT02891434
• Other Study ID Numbers: 248/15
• First Posted: September 7, 2016
• Last Update Posted: April 11, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Carlos Bandeira de Mello Monteiro, University of Sao Paulo:

Duchenne muscular dystrophy; motor learning; motor abilities

Additional relevant MeSH terms:

Muscular Dystrophies; Muscular Dystrophy, Duchenne; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Genetic Diseases, X-Linked