Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke

NCT ID: NCT04360460

Last Updated: 2023-05-23

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-03

Study Completion Date

2022-08-18

Brief Summary

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This is a single-blinded randomized control trial aiming to explore the use of immersive virtual reality (VR) training in conjunction with real-life tasks therapy in 75 first time stroke patients with upper limb weakness.

Detailed Description

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Patients will be randomized to a control or experimental group. The experimental group will receive immersive VR training followed by the translation of related tasks in a real life environment. The control group will perform the same tasks in a real life environment but will receive immersive VR exposure to a non-related task.

Conditions

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Hemiparesis as Late Effect of Cerebrovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Experimental

Virtual reality followed by translation into related functional tasks in a real life setting for 2 weeks + conventional therapies

Group Type EXPERIMENTAL

Immersive virtual reality + related functional translation into real-life

Intervention Type OTHER

The experimental group will perform tasks in an immersive virtual reality setting designed to encourage functional task performance for 30 minutes. The patient will then be brought to a real-life setting and evaluated on similar task performances for an additional 30 minutes for a total of 60 minutes per day, 3 times a week for 2 weeks.

Control

Virtual reality followed by translation into non-related functional tasks in a real life setting for 2 weeks + conventional therapies

Group Type ACTIVE_COMPARATOR

Immersive virtual reality + non-related translation into real-life

Intervention Type OTHER

The control group will also be asked to perform tasks in an immersive VR setting for 30 minutes, however tasks will be unrelated to the tasks performed in the real-life setting in the following 30 minutes. The control group will also receive 60 minutes of therapy a day, 3 times a week, for 2 weeks.

Interventions

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Immersive virtual reality + related functional translation into real-life

The experimental group will perform tasks in an immersive virtual reality setting designed to encourage functional task performance for 30 minutes. The patient will then be brought to a real-life setting and evaluated on similar task performances for an additional 30 minutes for a total of 60 minutes per day, 3 times a week for 2 weeks.

Intervention Type OTHER

Immersive virtual reality + non-related translation into real-life

The control group will also be asked to perform tasks in an immersive VR setting for 30 minutes, however tasks will be unrelated to the tasks performed in the real-life setting in the following 30 minutes. The control group will also receive 60 minutes of therapy a day, 3 times a week, for 2 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 18-90 years old
2. Hospitalized at Loma Linda East Campus Rehabilitation Hospital
3. First time stroke patient
4. Upper limb hemiparesis
5. English-speaking
6. Manual muscle testing of at least 2/5 in 3 or more muscle groups in affected upper limb

Exclusion Criteria

1. Active neck pain, headaches, or vertigo limiting ability to tolerate Virtual Reality Head Mounted Device
2. Patients with hemicraniectomy
3. Current uncontrolled seizures
4. Active infections requiring contact precautions
5. Cognitively unable to participate
6. Vision loss limiting ability to participate with VR therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Tarver, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

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Tom and Vi Zapara Rehabilitation Pavilion

Loma Linda, California, United States

Site Status

Countries

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United States

Other Identifiers

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5200147

Identifier Type: -

Identifier Source: org_study_id

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