- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02256007
Cognitive Motor Therapy Applications Using Videogame Platform
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Pamela Roberts
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standardized Assessments
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:
|
Videogame Assessments
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Experimental: Videogame Assessments
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:
|
Videogame Assessments
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Usability Questionnaire
Time Frame: Session in which participant completes standardized assessments before the patient's discharge from inpatient rehabilitation (within 2 weeks)
|
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)
|
Session in which participant completes standardized assessments before the patient's discharge from inpatient rehabilitation (within 2 weeks)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pamela Roberts, PhD, Cedars-Sinai Medical Center
- Principal Investigator: Jeffrey Wertheimer, PhD, Cedars-Sinai Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00031722
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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