Gaming Apps Post-Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Free Mobile or Tablet-based Applications on Stroke-Related Cognitive Impairment in Inpatient Rehabilitation

Conditions
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Stroke, Cognitive Impairment, Executive Dysfunction, Cognitive Change, Cognitive Deficit

Intervention / Treatment
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* Other: Mobile or tablet-based gaming applications
* Other: Stroke-related educational videos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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). | Other: Mobile or tablet-based gaming applications<br>* 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).<br>|
| Active Comparator: Control<br>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). | Other: Stroke-related educational videos<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From date of randomization until the day of discharge, assessed at beginning and end of this period, up to 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | From date of randomization until the day of discharge, assessed at end of this period, up to 5 weeks. Qualitative feedback only. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, cerebrovascular accident