Virtual Task in Amyotrophic Lateral Sclerosis
Efficacy of Different Interaction Devices Using Virtual Task in Amyotrophic Lateral Sclerosis
1 other identifier
interventional
60
1 country
1
Brief Summary
Thirty individuals with ALS (18 men and 12 women, mean age 59 years, range 44-74 years), and 30 healthy controls matched for age and gender, participated. Individuals with ALS and from the control group were randomly divided into three groups, each using a different communication device systems (Kinect®, Leap Motion Controller® or touchscreen) to perform two task phases (acquisition and retention). Performance was then explored in a third phase (transfer) by switching devices (two transfers); so that, all groups had contact with all communication interfaces.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2016
Shorter than P25 for not_applicable
1 active site
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
February 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2016
CompletedFirst Submitted
Initial submission to the registry
April 2, 2017
CompletedFirst Posted
Study publicly available on registry
April 13, 2017
CompletedApril 13, 2017
April 1, 2017
6 months
April 2, 2017
April 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Motor performance improvement in a virtual Timing Coincident task, comparing performance between LeapMotion, 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 Amyotrophic Lateral Sclerosis
3 months
Study Arms (6)
Acquisition on TouchScreen
EXPERIMENTALSubjects practice the task and retention TouchScreen, transfer 1 on LeapMotion and transfer 2 on Kinect
Acquisition on Kinect
EXPERIMENTALSubjects practice the task and retention Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
Acquisition on LeapMotion
EXPERIMENTALSubjects practice the task and retention LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.
Acquisition on TouchScreen Control Group
ACTIVE COMPARATORSubjects practice the task and retention TouchScreen, transfer 1 on LeapMotion and transfer 2 on Kinect
Acquisition on Kinect Control Group
ACTIVE COMPARATORSubjects practice the task and retention Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
Acquisition on LeapMotion Control Group
ACTIVE COMPARATORSubjects practice the task and retention LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.
Interventions
Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.
Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.
Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.
Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.
Eligibility Criteria
You may qualify if:
- individuals diagnosed with ALS defined according to the revised classification of El Escorial;
- individuals who regularly attended the Neuromuscular Disease Research Sector (SIDNM) of the Federal University of São Paulo
You may not qualify if:
- individuals who had other diagnosis of neuromuscular disease such as: progressive muscular atrophy (PMA), progressive bulbar paralysis (PBP), primary lateral sclerosis (PLS);
- individuals associated with other neurodegenerative diseases;
- those presenting established functional disability that would prevent the completion of the task.
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
Related Publications (1)
Trevizan IL, Silva TD, Dawes H, Massetti T, Crocetta TB, Favero FM, Oliveira ASB, de Araujo LV, Santos ACC, de Abreu LC, Coe S, Monteiro CBM. Efficacy of different interaction devices using non-immersive virtual tasks in individuals with Amyotrophic Lateral Sclerosis: a cross-sectional randomized trial. BMC Neurol. 2018 Dec 17;18(1):209. doi: 10.1186/s12883-018-1212-3.
PMID: 30558556DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos BM Monteiro, Ph.D.
University of Sao Paulo
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
April 2, 2017
First Posted
April 13, 2017
Study Start
February 2, 2016
Primary Completion
August 3, 2016
Study Completion
October 4, 2016
Last Updated
April 13, 2017
Record last verified: 2017-04