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

NCT ID: NCT02891434

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-12-31

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).

Conditions

Duchenne Muscular Dystrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Acquisition on TouchScreen

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

Group Type: EXPERIMENTAL

Acquisition on TouchScreen

Intervention Type: DEVICE

Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.

Acquisition on Kinect

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

Group Type: EXPERIMENTAL

Acquisition on Kinect

Intervention Type: DEVICE

Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.

Acquisition on LeapMotion

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

Group Type: EXPERIMENTAL

Acquisition on LeapMotion

Intervention Type: DEVICE

Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.

Acquisition on TouchScreen Control Group

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

Group Type: ACTIVE_COMPARATOR

Acquisition on TouchScreen

Intervention Type: DEVICE

Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.

Acquisition on Kinect Control Group

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

Group Type: ACTIVE_COMPARATOR

Acquisition on Kinect

Intervention Type: DEVICE

Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.

Acquisition on LeapMotion Control Group

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

Group Type: ACTIVE_COMPARATOR

Acquisition on LeapMotion

Intervention Type: DEVICE

Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.

Interventions

Acquisition on TouchScreen

Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.

Intervention Type: DEVICE

Acquisition on Kinect

Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.

Intervention Type: DEVICE

Acquisition on LeapMotion

Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• diagnosis of DMD.

Exclusion Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Carlos Bandeira de Mello Monteiro

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos BM Monteiro, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 30761066 (View on PubMed)

Other Identifiers

248/15

Identifier Type: -

Identifier Source: org_study_id