Gaming Apps Post-Stroke

Not Applicable

Withdrawn

• Conditions: Cognitive Impairment; Executive Dysfunction; Cognitive Deficit; Stroke; Cognitive Change
• Interventions: Other: Stroke-related educational videos; Other: Mobile or tablet-based gaming applications

• Registration Number: NCT04637100
• Lead Sponsor: Loma Linda University

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.

Study Timeline

• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-19
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-14
• Last Update Posted: 2021-06-16
• Study Start: 2021-12
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Stroke-related educational videos	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).
Experimental	Mobile or tablet-based gaming applications	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tom and Vi Zapara Rehabilitation Pavilion; 🇺🇸 Loma Linda, California, United States