StrokeGAPSNCT04637100
Gaming Apps Post-Stroke
A study testing Mobile or tablet-based gaming applications and Stroke-related educational videos in people with Stroke and Cognitive Impairment, run by Loma Linda University at 1 site in United States.
Trial summary
The investigators aim to explore the effect of puzzle mobile or tablet-based games on problem-solving impairment resulting from a first-time stroke. This is a randomized-controlled trial with the intervention arm consisting of puzzle gaming applications and the control arm consisting of stroke-relevant educational… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Stroke, Cognitive Impairment, Executive Dysfunction
- What is being tested?
- Mobile or tablet-based gaming applications and Stroke-related educational videos
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2021to Apr 2022
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-89
- Hospitalized at Loma Linda East Campus Rehabilitation Hospital
- First time stroke patient
- mild to moderate problem-solving impairment without severe deficit in any other cognitive domain on admission speech evaluation
- Have daily access while inpatient to a personally owned Apple or Android smartphone or tablet device prior to the initial session.
Who cannot join
- Unable to understand and follow verbal and written instructions in English
- Presence of aphasia that limits device use or ability to provide consent
- Presence of pre-stroke speech, language, or cognitive disorder
- Unable to operate device due to cognitive, physical, or visual impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Tom and Vi Zapara Rehabilitation Pavilion
Loma Linda, California, 92354
About this study
Official title: Effect of Free Mobile or Tablet-based Applications on Stroke-Related Cognitive Impairment in Inpatient Rehabilitation
The investigators aim to explore the effect of puzzle mobile or tablet-based games on problem-solving impairment resulting from a first-time stroke. This is a randomized-controlled trial with the intervention arm consisting of puzzle gaming applications and the control arm consisting of stroke-relevant educational videos provided and encouraged throughout the course of participants' acute inpatient rehabilitation stay.
Read the detailed description
Study subjects will be randomized to a control or experimental group and allocation will be concealed. The experimental group will consist of the subject utilizing their personal mobile or tablet device to play a pre-selected set of problem-solving games for a goal of 1 hour daily. The control group will utilize their personal mobile or tablet device to perform the non-problem-solving task of watching educational videos of their choice from a pre-selected set of videos for the same amount of time daily. The intervention gaming arm will be provided different gaming apps if they lose interest or find a particular game too easy or too difficult. The control video arm will be provided different educational videos according to their needs that may change throughout their inpatient stay.
- Being tested
- Mobile or tablet-based gaming applications, Stroke-related educational videos
- Keywords
- Stroke, cerebrovascular accident
- Medical subject headings
- Stroke, Cognitive Dysfunction, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile or tablet-based gaming applicationsOther
Subject will use their own personal smartphone or tablet device to play from a collection of pre-selected gaming applications. The collection is made of puzzle-type games available on both Android and iOS without excessive ads and with clear or self-explanatory instructions. Subject will be instructed to play for 1 hour daily for the duration of their acute inpatient rehabilitation stay (approximately 3 weeks).
Stroke-related educational videosOther
Subject will use their own personal smartphone or tablet device to watch videos from a collection of pre-selected educational videos. These include topics on stroke recognition, stroke recovery process, patient experiences with stroke, rehabilitation after stroke, activities of daily living equipment instructions. Subject will be instructed to watch for 1 hour daily for the duration of their acute inpatient rehabilitation stay (approximately 3 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The patient will utilize their personal mobile or tablet device to play a pre-selected set of problem-solving games for a goal of 1 hour daily for the duration of their inpatient rehabilitation stay (approximately 3 weeks). Receives: Other: Mobile or tablet-based gaming applications |
| Control | Active comparator | The patient will utilize their personal mobile or tablet device to watch a pre-selected set of stroke-related educational videos for a goal of 1 hour daily for the duration of their inpatient rehabilitation stay (approximately 3 weeks). Receives: Other: Stroke-related educational videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scales of Cognitive and Communicative Ability for Neurorehabilitation (SCCAN)
Assesses cognitive-communicative deficits and functional ability in patients in rehabilitation hospitals, clinics, and skilled nursing facilities. The SCCAN contents relate to daily activities that adults would be expected to perform for independent living. The SCCAN has eight scales and a total score:
Oral Expression, Orientation, Memory, Speech Comprehension, Reading Comprehension, Writing, Attention, Problem Solving
Typical functioning = 87-94 Mild impairment = 69-86 Moderate impairment = 47-68 Severe impairment = 0-46
Measured: From date of randomization until the day of discharge, assessed at beginning and end of this period, up to 5 weeks
Secondary outcomes (3)
Montreal Cognitive Assessment (MOCA)
Rapid screen of cognitive abilities designed to detect mild cognitive dysfunction consisting of 16 items and 11 categories assessing multiple cognitive domains
No cognitive impairment >=25 Mild cognitive impairment = 20-24 Severe cognitive impairment < 20
Measured: From date of randomization until the day of discharge, assessed at beginning and end of this period, up to 5 weeks
Modified Gaming Engagement Questionnaire
15-item questionnaire for feedback on engagement during game-playing or video watching
Measured: From date of randomization until the day of discharge, assessed at end of this period, up to 5 weeks. Qualitative feedback only.
Program Evaluation
11 item questionnaire for feedback on participant experience
Measured: From date of randomization until the day of discharge, assessed at end of this period, up to 5 weeks. Qualitative feedback only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study startDec 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Why it stopped: Change in research personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Tarver, Loma Linda University
- Investigators
- Christopher Tarver, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637100
- Sponsor's protocol ID
- 5200471
- Acronym
- GAPS
- Status last verified
- Jun 2021
- First submitted
- 3 Nov 2020
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Free Mobile or Tablet-based Applications on Stroke-Related Cognitive Impairment in Inpatient Rehabilitation
- ClinicalTrials.gov ID
- NCT04637100
- Acronym / sponsor ID
- GAPS / 5200471
- Keywords
- Stroke, cerebrovascular accident
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in research personnel
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 19 Nov 2020 (actual)
- 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.
The investigators aim to explore the effect of puzzle mobile or tablet-based games on problem-solving impairment resulting from a first-time stroke. This is a randomized-controlled trial with the intervention arm consisting of puzzle gaming applications and the control arm consisting of stroke-relevant educational videos provided and encouraged throughout the course of participants' acute inpatient rehabilitation stay.
Detailed description
Study subjects will be randomized to a control or experimental group and allocation will be concealed. The experimental group will consist of the subject utilizing their personal mobile or tablet device to play a pre-selected set of problem-solving games for a goal of 1 hour daily. The control group will utilize their personal mobile or tablet device to perform the non-problem-solving task of watching educational videos of their choice from a pre-selected set of videos for the same amount of time daily. The intervention gaming arm will be provided different gaming apps if they lose interest or find a particular game too easy or too difficult. The control video arm will be provided different educational videos according to their needs that may change throughout their inpatient stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Mobile or tablet-based gaming applicationsThe patient will utilize their personal mobile or tablet device to play a pre-selected set of problem-solving games for a goal of 1 hour daily for the duration of their inpatient rehabilitation stay (approximately 3 weeks). |
| Control | Active comparator | Other: Stroke-related educational videosThe patient will utilize their personal mobile or tablet device to watch a pre-selected set of stroke-related educational videos for a goal of 1 hour daily for the duration of their inpatient rehabilitation stay (approximately 3 weeks). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-89
- Hospitalized at Loma Linda East Campus Rehabilitation Hospital
- First time stroke patient
- mild to moderate problem-solving impairment without severe deficit in any other cognitive domain on admission speech evaluation
- Have daily access while inpatient to a personally owned Apple or Android smartphone or tablet device prior to the initial session.
Key exclusion criteria (4 listed)
- Unable to understand and follow verbal and written instructions in English
- Presence of aphasia that limits device use or ability to provide consent
- Presence of pre-stroke speech, language, or cognitive disorder
- Unable to operate device due to cognitive, physical, or visual impairment
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 |
|---|---|---|
| Mobile or tablet-based gaming applicationsSubject will use their own personal smartphone or tablet device to play from a collection of pre-selected gaming applications. The collection is made of puzzle-type games available on both Android and iOS without excessive ads and with clear or self-explanatory instructions. Subject will be instructed to play for 1 hour daily for the duration of their acute inpatient rehabilitation stay (approximately 3 weeks). | Other | Experimental |
| Stroke-related educational videosSubject will use their own personal smartphone or tablet device to watch videos from a collection of pre-selected educational videos. These include topics on stroke recognition, stroke recovery process, patient experiences with stroke, rehabilitation after stroke, activities of daily living equipment instructions. Subject will be instructed to watch for 1 hour daily for the duration of their acute inpatient rehabilitation stay (approximately 3 weeks). | Other | Control |
Primary outcome
Scales of Cognitive and Communicative Ability for Neurorehabilitation (SCCAN)
Time frame: From date of randomization until the day of discharge, assessed at beginning and end of this period, up to 5 weeks
Assesses cognitive-communicative deficits and functional ability in patients in rehabilitation hospitals, clinics, and skilled nursing facilities. The SCCAN contents relate to daily activities that adults would be expected to perform for independent living. The SCCAN has eight scales and a total score: Oral Expression, Orientation, Memory, Speech Comprehension, Reading Comprehension, Writing, Attention, Problem Solving Typical functioning = 87-94 Mild impairment = 69-86 Moderate impairment = 47-68 Severe impairment = 0-46
3 secondary outcomes
Montreal Cognitive Assessment (MOCA)
Time frame: From date of randomization until the day of discharge, assessed at beginning and end of this period, up to 5 weeks
Modified Gaming Engagement Questionnaire
Time frame: From date of randomization until the day of discharge, assessed at end of this period, up to 5 weeks. Qualitative feedback only.
Program Evaluation
Time frame: From date of randomization until the day of discharge, assessed at end of this period, up to 5 weeks. Qualitative feedback only.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Christopher Tarver, MD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile or tablet-based gaming applications and Stroke-related educational videos in people with Stroke and Cognitive Impairment, run by Loma Linda University 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 16 Jun 2021. 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 withdrawn before enrolling participants, so there are no results.
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?
Scales of Cognitive and Communicative Ability for Neurorehabilitation (SCCAN) (time frame: From date of randomization until the day of discharge, assessed at beginning and end of this period, up to 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2021.