NCT03002298

Brief Summary

With the growing accessibility of computer-assisted technology, one option for rehabilitation programs for individuals with Duchenne muscular dystrophy (DMD) is the use of virtual reality environments to enhance motor practice. Thus, it is important to examine whether performance improvements in the virtual environment generalize to the natural environment. To examine this issue, we had 64 individuals, 32 of which were individuals with DMD and 32 were typically developing individuals. The groups practiced two coincidence timing tasks. In the more tangible button-press task, the individuals were required to 'intercept' a falling virtual object at the moment it reached the interception point by pressing a key on the computer. In the more abstract task, they were instructed to 'intercept' the virtual object by making a hand movement in a virtual environment using a webcam.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

December 19, 2016

Last Update Submit

April 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Motor Learning test by using a timing coincident task in virtual reality

    1 day

Study Arms (4)

DMD gesture task

EXPERIMENTAL

Experimental group that made the task using a gesture in front of a webcam

Behavioral: DMD gesture task

DMD button-press task

EXPERIMENTAL

Experimental group that made the task pressing the button

Behavioral: DMD button-press task

Control group gesture task

ACTIVE COMPARATOR

Control group that made the task using a gesture in front of a webcam

Behavioral: Control group gesture task

Control group button-press task

ACTIVE COMPARATOR

Control group that made the task pressing the button

Behavioral: Control group button-press task

Interventions

Timing coincident task in a virtual environment, using motor learning protocol in which a gesture in front of a webcam shoub be done to reach the task

DMD gesture task

Timing coincident task in a virtual environment, using motor learning protocol in which the task shoub be done by pressing a button on the keyboard

DMD button-press task

Timing coincident task in a virtual environment, using motor learning protocol in which a gesture in front of a webcam shoub be done to reach the task

Control group gesture task

Timing coincident task in a virtual environment, using motor learning protocol in which the task shoub be done by pressing a button on the keyboard

Control group button-press task

Eligibility Criteria

Age12 Years - 32 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • medical diagnosis of Duchenne Muscular Dystrophy confirmed by molecular method and/or protein expression in skeletal muscle;
  • signing of an informed consent form from the individual or person legally responsible.

You may not qualify if:

  • presence of associated comorbidities;
  • inability in comprehension of the task.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 23, 2016

Study Start

January 1, 2016

Primary Completion

August 1, 2016

Study Completion

October 1, 2016

Last Updated

April 11, 2017

Record last verified: 2017-04