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Cognitive Motor Therapy Applications Using Videogame Platform

Primary Purpose

Stroke

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Paper and Pencil Assessments
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring Videogames; stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • New onset stroke

  • Ability to follow one-step commands

    • All participants must be admitted to the inpatient rehabilitation unit at Cedars-Sinai Medical Center
    • Scores needed for Participation in Study on the Complex Ideational Material-Short Form from the Boston Diagnostic Aphasia Examination and the Montreal Cognitive Assessment:
  • Complex Ideational Material-Short Form from the Boston Diagnostic Aphasia Examination-Participants must obtain a total score of at least 5/6 item pairs to participate
  • Montreal Cognitive Assessment-Participants must obtain a total score of 16 or greater and obtain a score of 6/6 on the orientation subtest
  • In order to participate, participants must meet both of the above criteria

Exclusion Criteria:

  • Patients who do not meet inclusion criteria as noted above.

Sites / Locations

  • Pamela Roberts

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standardized Assessments

Videogame Assessments

Arm Description

Standardized Assessments (paper and pencil tests) to be given to each participant. The standardized assessments will be completed in paper and pencil format. These tests include: Line Bisection Test Patient Reported Outcomes Trial Making A and B Usability Questionnaire

Videogame assessments will be performed by each participant using videogames. The videogame assessments will be performed using videogames on a tabletop platform with touchscreen which includes: Line Crossing Patient Reported Outcomes Trial Making A & B-Asteroid Adventure Game Usability Questionnaire

Outcomes

Primary Outcome Measures

Usability Questionnaire
Participant will perform videogame assessments and standardized paper-pencil assessments and evaluate the utility of the touch screen tests compared to the traditional testing methods using the Usability Questionnaire. The focus will be on the Usability Questionnaire (not the video or paper assessments)

Secondary Outcome Measures

Full Information

First Posted
September 28, 2014
Last Updated
April 3, 2018
Sponsor
Cedars-Sinai Medical Center
Collaborators
Blue Marble Rehab Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02256007
Brief Title
Cognitive Motor Therapy Applications Using Videogame Platform
Official Title
Cognitive Motor Therapy Applications Using Videogame Platform
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Not feasible in inpatient setting
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
Blue Marble Rehab Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study designs and develops an evidence-based game approach that will enhance the investigators understanding and usability of electronic tools to measure cognitive and sensorimotor abilities in an inpatient rehabilitation stroke population.
Detailed Description
The rehabilitation industry is the incipient stages of developing and using electronic based assessment and intervention tools. With the growing understanding of cognitive recovery following stroke, rehabilitation specialists are optimistic that appropriate rehabilitation interventions may optimize and enhance functional outcomes. The use of technology based assessments via video games may assist in a patient's cognitive recovery. Design and development of an evidence-based game approach will enhance the investigators understanding and usability of electronic tools to measure cognitive and sensorimotor abilities. There is no intervention only an assessment for usability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Videogames; stroke

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two treatment sessions during an inpatient rehabilitation stay. Part 1 is the screening (Montreal Cognitive Assessment and the Boston Diagnostic Aphasia Examination). Assessments will be given to make sure patient is eligible for the study. If eligible, will complete part 2-paper and pencil tasks and video game tests.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standardized Assessments
Arm Type
Active Comparator
Arm Description
Standardized Assessments (paper and pencil tests) to be given to each participant. The standardized assessments will be completed in paper and pencil format. These tests include: Line Bisection Test Patient Reported Outcomes Trial Making A and B Usability Questionnaire
Arm Title
Videogame Assessments
Arm Type
Experimental
Arm Description
Videogame assessments will be performed by each participant using videogames. The videogame assessments will be performed using videogames on a tabletop platform with touchscreen which includes: Line Crossing Patient Reported Outcomes Trial Making A & B-Asteroid Adventure Game Usability Questionnaire
Intervention Type
Other
Intervention Name(s)
Paper and Pencil Assessments
Intervention Description
Videogame Assessments
Primary Outcome Measure Information:
Title
Usability Questionnaire
Description
Participant will perform videogame assessments and standardized paper-pencil assessments and evaluate the utility of the touch screen tests compared to the traditional testing methods using the Usability Questionnaire. The focus will be on the Usability Questionnaire (not the video or paper assessments)
Time Frame
Session in which participant completes standardized assessments before the patient's discharge from inpatient rehabilitation (within 2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: New onset stroke Ability to follow one-step commands All participants must be admitted to the inpatient rehabilitation unit at Cedars-Sinai Medical Center Scores needed for Participation in Study on the Complex Ideational Material-Short Form from the Boston Diagnostic Aphasia Examination and the Montreal Cognitive Assessment: Complex Ideational Material-Short Form from the Boston Diagnostic Aphasia Examination-Participants must obtain a total score of at least 5/6 item pairs to participate Montreal Cognitive Assessment-Participants must obtain a total score of 16 or greater and obtain a score of 6/6 on the orientation subtest In order to participate, participants must meet both of the above criteria Exclusion Criteria: Patients who do not meet inclusion criteria as noted above.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Roberts, PhD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Wertheimer, PhD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamela Roberts
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No subjects completed study
Citations:
PubMed Identifier
20302419
Citation
King M, Hale L, Pekkari A, Persson M, Gregorsson M, Nilsson M. An affordable, computerised, table-based exercise system for stroke survivors. Disabil Rehabil Assist Technol. 2010 Jul;5(4):288-93. doi: 10.3109/17483101003718161.
Results Reference
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PubMed Identifier
22480353
Citation
Lewis GN, Rosie JA. Virtual reality games for movement rehabilitation in neurological conditions: how do we meet the needs and expectations of the users? Disabil Rehabil. 2012;34(22):1880-6. doi: 10.3109/09638288.2012.670036. Epub 2012 Apr 5.
Results Reference
background
PubMed Identifier
21495917
Citation
Lewis GN, Woods C, Rosie JA, McPherson KM. Virtual reality games for rehabilitation of people with stroke: perspectives from the users. Disabil Rehabil Assist Technol. 2011;6(5):453-63. doi: 10.3109/17483107.2011.574310. Epub 2011 Apr 17.
Results Reference
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Cognitive Motor Therapy Applications Using Videogame Platform

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