StrokeNCT02256007
Cognitive Motor Therapy Applications Using Videogame Platform
A study testing Paper and Pencil Assessments in people with Stroke, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Paper and Pencil Assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who do not meet inclusion criteria as noted above.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Paper and Pencil Assessments
- Keywords
- Videogames; stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paper and Pencil AssessmentsOther
Videogame Assessments
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Paper and Pencil Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Session in which participant completes standardized assessments before the patient's discharge from inpatient rehabilitation (within 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Not feasible in inpatient setting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Marble Rehab Inc
- Responsible party
- Principal investigator, Pamela Roberts, Cedars-Sinai Medical Center
- Investigators
- Pamela Roberts, PhD, Principal investigator, Cedars-Sinai Medical CenterJeffrey Wertheimer, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256007
- Sponsor's protocol ID
- Pro00031722
- Status last verified
- Apr 2018
- First submitted
- 28 Sep 2014
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No subjects completed study
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.
PubMed 20302419Lewis 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.
PubMed 22480353Lewis 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.
PubMed 21495917
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Motor Therapy Applications Using Videogame Platform
- ClinicalTrials.gov ID
- NCT02256007
- Acronym / sponsor ID
- Pro00031722
- Conditions
- Stroke
- Keywords
- Videogames; stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not feasible in inpatient setting
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Blue Marble Rehab Inc
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standardized Assessments | Active comparator | Other: Paper and Pencil AssessmentsStandardized 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 | Experimental | Other: Paper and Pencil AssessmentsVideogame 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- New onset stroke
- Ability to follow one-step commands
- 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
Key exclusion criteria (1 listed)
- Patients who do not meet inclusion criteria as noted above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paper and Pencil AssessmentsVideogame Assessments | Other | Standardized Assessments, Videogame Assessments |
Primary outcome
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)
Results and safety
The study was stopped early (reason given: Not feasible in inpatient setting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 20302419King 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.
- Background: PubMed 22480353Lewis 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.
- Background: PubMed 21495917Lewis 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.
- Individual participant dataSharing planned: No. No subjects completed study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Roberts, PhD principal investigator
Cedars-Sinai Medical Center
Jeffrey Wertheimer, PhD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paper and Pencil Assessments in people with Stroke, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not feasible in inpatient setting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability Questionnaire (time frame: Session in which participant completes standardized assessments before the patient's discharge from inpatient rehabilitation (within 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02256007, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.