Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 43 of 677 for:    amyotrophic lateral sclerosis

Virtual Task in Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03113630
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Carlos Bandeira de Mello Monteiro, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Device: Acquisition on TouchScreen Device: Acquisition on Kinect Device: Acquisition on LeapMotion Device: Acquisition on TouchScreen Control Group Device: Acquisition on Kinect Control Group Device: Acquisition on LeapMotion Control Group Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Different Interaction Devices Using Virtual Task in Amyotrophic Lateral Sclerosis
Actual Study Start Date : February 2, 2016
Actual Primary Completion Date : August 3, 2016
Actual Study Completion Date : October 4, 2016


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




Primary Outcome Measures :
  1. Motor performance improvement in a virtual Timing Coincident task, comparing performance between LeapMotion, 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 Amyotrophic Lateral Sclerosis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113630


Locations
Layout table for location information
Brazil
Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo
Sao Paulo, Brazil, 03828-000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Layout table for investigator information
Principal Investigator: Carlos BM Monteiro, Ph.D. University of Sao Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Carlos Bandeira de Mello Monteiro, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03113630     History of Changes
Other Study ID Numbers: 105/15
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carlos Bandeira de Mello Monteiro, University of Sao Paulo:
Amyotrophic Lateral Sclerosis
Virtual Reality Exposure Therapy
User-Computer Interface
Rehabilitation
Motor Activity
Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases