Gaming Apps Post-Stroke

NCT ID: NCT04637100

Last Updated: 2021-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2022-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Cognitive Impairment Executive Dysfunction Cognitive Change Cognitive Deficit

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Mobile or tablet-based gaming applications

Intervention Type 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).

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).

Group Type ACTIVE_COMPARATOR

Stroke-related educational videos

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Christopher Tarver

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christopher Tarver, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tom and Vi Zapara Rehabilitation Pavilion

Loma Linda, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5200471

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.