Gaming Apps Post-Stroke

Stroke Clinical Trial

— GAPS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04637100
• Other study ID #: 5200471
• Status: Withdrawn
• Phase: N/A
• Start date: December 2021
• Est. completion date: April 2022

Study information

• Verified date: June 2021
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Change
• Cognitive Deficit
• Cognitive Dysfunction
• Cognitive Impairment
• Executive Dysfunction
• Stroke

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Tom and Vi Zapara Rehabilitation Pavilion	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From date of randomization until the day of discharge, assessed at beginning and end of this period, up to 5 weeks
Secondary	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	From date of randomization until the day of discharge, assessed at beginning and end of this period, up to 5 weeks
Secondary	Modified Gaming Engagement Questionnaire	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.
Secondary	Program Evaluation	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.