NCT02256007

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

10 months

First QC Date

September 28, 2014

Last Update Submit

April 3, 2018

Conditions

Keywords

Videogames; stroke

Outcome Measures

Primary Outcomes (1)

  • 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)

    Session in which participant completes standardized assessments before the patient's discharge from inpatient rehabilitation (within 2 weeks)

Study Arms (2)

Standardized Assessments

ACTIVE COMPARATOR

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

Other: Paper and Pencil Assessments

Videogame Assessments

EXPERIMENTAL

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

Other: Paper and Pencil Assessments

Interventions

Videogame Assessments

Standardized AssessmentsVideogame Assessments

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamela Roberts

Los Angeles, California, 90048, United States

Location

Related Publications (3)

  • 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.

    PMID: 20302419BACKGROUND
  • 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.

    PMID: 22480353BACKGROUND
  • 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.

    PMID: 21495917BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Paper

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Pamela Roberts, PhD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR
  • Jeffrey Wertheimer, PhD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director

Study Record Dates

First Submitted

September 28, 2014

First Posted

October 3, 2014

Study Start

September 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

April 5, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

No subjects completed study

Locations