Virtual Reality in Stroke Rehabilitation

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Ischemic Stroke

Treatments: Device: Virtual Reality (VR) System; Procedure: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT04080791

IRB00052687

Details and patient eligibility

About

The purpose of this research study is to investigate the effects of Virtual Reality (VR) as a treatment intervention to increase physical and cognitive function in stroke survivors.

Full description

In this pilot study, the objective is to determine if there is an increase in MoCA (Montreal Cognitive Assessment), MFRT (Modified Functional Reach Test), and FMA-UA (Fugl-Meyer Assessment Upper Extremity) scores of participants who receive the VR intervention in addition to traditional inpatient rehabilitation standard of care (experimental group) versus participants who receive the traditional standard of care (control group).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients Age 18 and older admitted to inpatient rehabilitation with a projected LOS (length of stay) of 10 days or more within the open data collection period for treatment of ischemic stroke and agree to participate in the study in addition to traditional intensive rehabilitation therapy.

Exclusion criteria

• Individual patients who exhibit the following symptoms or medical history or are not medically cleared for participation will be excluded:
• History of, or high risk for, seizures
• Feed tube, tracheotomy, or other medical devices that would preclude the use or wear of the VR headset as it covers the face and head
• Blindness
• History of mental health issues such as schizophrenia, manic episodes, active psychosis, or other mental health issues that may be exacerbated by exposure to VR
• Open wounds that would preclude use for the VR headset

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Experimental Group- Virtual Reality (VR) Treatment

Experimental group

Description:

The participants in the experimental group will complete the educational/training session on how to use the VR equipment and programs (30 minutes). The following day, participants will begin the VR intervention attending a daily 30-minute sessions for 8 days or until a discharge date has been set, whichever comes first.

Treatment:

Procedure: Standard of care

Device: Virtual Reality (VR) System

Standard of care group

Active Comparator group

Description:

The control group participants will receive the traditional daily 30-minute intensive therapy regimen provided during acute inpatient rehabilitation stroke treatment protocol. Prior to discharge, control group participants will meet with a licensed clinical therapist to complete the cognitive and physical assessments for the posttest evaluation.

Treatment:

Procedure: Standard of care