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Gaming Apps Post-Stroke (GAPS)

Primary Purpose

Stroke, Cognitive Impairment, Executive Dysfunction

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile or tablet-based gaming applications
Stroke-related educational videos
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, cerebrovascular accident

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tom and Vi Zapara Rehabilitation Pavilion

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Modified Gaming Engagement Questionnaire
15-item questionnaire for feedback on engagement during game-playing or video watching
Program Evaluation
11 item questionnaire for feedback on participant experience

Full Information

First Posted
November 3, 2020
Last Updated
June 14, 2021
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT04637100
Brief Title
Gaming Apps Post-Stroke
Acronym
GAPS
Official Title
Effect of Free Mobile or Tablet-based Applications on Stroke-Related Cognitive Impairment in Inpatient Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Change in research personnel
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cognitive Impairment, Executive Dysfunction, Cognitive Change, Cognitive Deficit
Keywords
Stroke, cerebrovascular accident

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Mobile or tablet-based gaming applications
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Stroke-related educational videos
Intervention Description
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).
Primary Outcome Measure Information:
Title
Scales of Cognitive and Communicative Ability for Neurorehabilitation (SCCAN)
Description
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
Time Frame
From date of randomization until the day of discharge, assessed at beginning and end of this period, up to 5 weeks
Secondary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MOCA)
Description
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
Time Frame
From date of randomization until the day of discharge, assessed at beginning and end of this period, up to 5 weeks
Title
Modified Gaming Engagement Questionnaire
Description
15-item questionnaire for feedback on engagement during game-playing or video watching
Time Frame
From date of randomization until the day of discharge, assessed at end of this period, up to 5 weeks. Qualitative feedback only.
Title
Program Evaluation
Description
11 item questionnaire for feedback on participant experience
Time Frame
From date of randomization until the day of discharge, assessed at end of this period, up to 5 weeks. Qualitative feedback only.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Tarver, MD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom and Vi Zapara Rehabilitation Pavilion
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Gaming Apps Post-Stroke

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