NCT02891434

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;

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

8 months

First QC Date

August 17, 2016

Last Update Submit

April 8, 2017

Conditions

Keywords

Duchenne muscular dystrophymotor learningmotor abilities

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (6)

Acquisition on TouchScreen

EXPERIMENTAL

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

Device: Acquisition on TouchScreen

Acquisition on Kinect

EXPERIMENTAL

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

Device: Acquisition on Kinect

Acquisition on LeapMotion

EXPERIMENTAL

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

Device: Acquisition on LeapMotion

Acquisition on TouchScreen Control Group

ACTIVE COMPARATOR

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

Device: Acquisition on TouchScreen

Acquisition on Kinect Control Group

ACTIVE COMPARATOR

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

Device: Acquisition on Kinect

Acquisition on LeapMotion Control Group

ACTIVE COMPARATOR

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

Device: Acquisition on LeapMotion

Interventions

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

Acquisition on TouchScreenAcquisition on TouchScreen Control Group

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

Acquisition on KinectAcquisition on Kinect Control Group

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

Acquisition on LeapMotionAcquisition on LeapMotion Control Group

Eligibility Criteria

Age9 Years - 34 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • diagnosis of DMD.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 03828-000, Brazil

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Carlos BM Monteiro, Ph.D.

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 17, 2016

First Posted

September 7, 2016

Study Start

February 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations