Gaming Apps Post-Stroke (GAPS)

June 14, 2021 updated by: Christopher Tarver, Loma Linda University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Tom and Vi Zapara Rehabilitation Pavilion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
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
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).
Active Comparator: Control
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scales of Cognitive and Communicative Ability for Neurorehabilitation (SCCAN)
Time Frame: 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
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)
Time Frame: 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
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
Time Frame: 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
From date of randomization until the day of discharge, assessed at end of this period, up to 5 weeks. Qualitative feedback only.
Program Evaluation
Time Frame: 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
From date of randomization until the day of discharge, assessed at end of this period, up to 5 weeks. Qualitative feedback only.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 14, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5200471

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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