Virtual Reality in Stroke Rehabilitation

Not Applicable

Withdrawn

• Conditions: Ischemic Stroke
• Interventions: Device: Virtual Reality (VR) System; Procedure: Standard of care

• Registration Number: NCT04080791
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-06
• Status Verified: 2023-03
• Study Start: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-31
• Primary Completion: 2024-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group- Virtual Reality (VR) Treatment	Standard of care	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.
Experimental Group- Virtual Reality (VR) Treatment	Virtual Reality (VR) System	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.
Standard of care group	Standard of care	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.

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MoCA)	Up to 8 days after baseline	Scores range from 0 to 30 with higher scores denoting better outcomes.
Modified Functional Reach Test (MFRT)	Up to 8 days after baseline	The Modified Functional Reach Test will be used to measure physical functioning. Measurements are the maximum distance the patient can reach forward while sitting in a fixed position. A score of 6 or less indicates a significant increased risk of falls. A score between 6-10 inches indicates a moderate risk for falls.
FMA-UE (Fugl-Meyer Assessment for Upper Extremity)	Up to 8 days after baseline	Fugl-Meyer Assessment for Upper Extremity will be used to measure upper extremity motor function. Scores range from 0 (unable to do the task) to 66 (task performed fully). Higher scores denote better outcome.

Secondary Outcome Measures

Name	Time	Method
Wong-Baker FACES scale	immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline	For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.
Pain intensity self-report ratings	immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline	For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.