Cognitive Change, Cognitive Deficit, Cognitive Impairment, Executive Dysfunction, Stroke
Conditions
Keywords
Stroke, cerebrovascular accident
Brief 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 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.
Interventions
OTHERMobile or tablet-based gaming applications
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).
OTHERStroke-related educational videos
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).
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-89 2. Hospitalized at Loma Linda East Campus Rehabilitation Hospital 3. First time stroke patient 4. mild to moderate problem-solving impairment without severe deficit in any other cognitive domain on admission speech evaluation 5. Have daily access while inpatient to a personally owned Apple or Android smartphone or tablet device prior to the initial session.
Exclusion criteria
1. Unable to understand and follow verbal and written instructions in English 2. Presence of aphasia that limits device use or ability to provide consent 3. Presence of pre-stroke speech, language, or cognitive disorder 4. Unable to operate device due to cognitive, physical, or visual impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scales of Cognitive and Communicative Ability for Neurorehabilitation (SCCAN) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment (MOCA) | From date of randomization until the day of discharge, assessed at beginning and end of this period, up to 5 weeks | 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 |
| Modified Gaming Engagement Questionnaire | From date of randomization until the day of discharge, assessed at end of this period, up to 5 weeks. Qualitative feedback only. | 15-item questionnaire for feedback on engagement during game-playing or video watching |
| Program Evaluation | From date of randomization until the day of discharge, assessed at end of this period, up to 5 weeks. Qualitative feedback only. | 11 item questionnaire for feedback on participant experience |
Countries
United States
Outcome results
None listed