Gaming Apps Post-Stroke

NCT04637100 | Withdrawn

• 1 other identifier: 5200471
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cognitive Impairment; Executive Dysfunction; Cognitive Change; Cognitive Deficit

Keywords

Stroke; cerebrovascular accident

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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.

• Program Evaluation

  From date of randomization until the day of discharge, assessed at end of this period, up to 5 weeks. Qualitative feedback only.

Study Arms (2)

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

Control

ACTIVE COMPARATOR

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

Interventions

Mobile or tablet-based gaming applications OTHER

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).

Experimental

Stroke-related educational videos OTHER

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).

Control

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Tom and Vi Zapara Rehabilitation Pavilion

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction; Cognition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Christopher Tarver, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 19, 2020
• Study Start: December 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)