Virtual Reality in Stroke Rehabilitation

March 28, 2023 updated by: Wake Forest University Health Sciences

Efficacy of Virtual Reality in Stroke Rehabilitation

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peggy Comer, LRT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group- Virtual Reality (VR) Treatment
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.
Device: Virtual Reality (VR) System
The participants will undergo daily 30-minute sessions for 8 days of Virtual Reality (VR) with a VR system using commercially available default programs in addition to traditional intensive therapy regimen provided during inpatient rehab.
Procedure: Standard of care
Control group participants will receive the traditional daily 30-minute intensive therapy regimen provided during acute inpatient rehabilitation stroke treatment protocol.
Active Comparator: Standard of care group
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.
Procedure: Standard of care
Control group participants will receive the traditional daily 30-minute intensive therapy regimen provided during acute inpatient rehabilitation stroke treatment protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment (MoCA)
Time Frame: baseline
Scores range from 0 to 30 with higher scores denoting better outcomes.
baseline
Montreal Cognitive Assessment (MoCA)
Time Frame: Up to 8 days after baseline
Scores range from 0 to 30 with higher scores denoting better outcomes.
Up to 8 days after baseline
Modified Functional Reach Test (MFRT)
Time Frame: 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.
baseline
Modified Functional Reach Test (MFRT)
Time Frame: 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.
Up to 8 days after baseline
FMA-UE (Fugl-Meyer Assessment for Upper Extremity)
Time Frame: 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.
baseline
FMA-UE (Fugl-Meyer Assessment for Upper Extremity)
Time Frame: 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.
Up to 8 days after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity self-report ratings
Time Frame: prior to 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.
prior to VR treatment, day 1, and days 2, 3, 4, 5, 6, 7, and 8 after baseline
Pain intensity self-report ratings
Time Frame: 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.
immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline
Wong-Baker FACES scale
Time Frame: prior to 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.
prior to VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline
Wong-Baker FACES scale
Time Frame: 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.
immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Peggy Cromer, LRT, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

September 3, 2019

First Submitted That Met QC Criteria

September 3, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00052687

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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