Clinical trial NCT04637100: Gaming Apps Post-Stroke
Official title: Effect of Free Mobile or Tablet-based Applications on Stroke-Related Cognitive Impairment in Inpatient Rehabilitation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Cognitive Impairment
Executive Dysfunction
Cognitive Change
Cognitive Deficit
Keywords: Stroke
cerebrovascular accident
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Scales of Cognitive and Communicative Ability for Neurorehabilitation (SCCAN)
timeFrame: From date of randomization until the day of discharge, assessed at beginning and end of this period, up to 5 weeks
Secondary outcomes:
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: From date of randomization until the day of discharge, assessed at beginning and end of this period, up to 5 weeks
measure: Modified Gaming Engagement Questionnaire
timeFrame: From date of randomization until the day of discharge, assessed at end of this period, up to 5 weeks. Qualitative feedback only.
measure: Program Evaluation
timeFrame: From date of randomization until the day of discharge, assessed at end of this period, up to 5 weeks. Qualitative feedback only.
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Tom and Vi Zapara Rehabilitation Pavilion
state: California
Study officials:
affiliation: Loma Linda University
name: Christopher Tarver, MD
role: PRINCIPAL_INVESTIGATOR
References: