Development of a Virtual Reality Spatial Retraining Therapy to Improve Neglect in Stroke Survivors (VR-SRT)

June 2, 2023 updated by: Peii Chen, Kessler Foundation
Participants in this study will help test and develop a virtual reality (VR) system that is being designed to help people with spatial neglect after stroke.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants in this study will be tested to see if they have spatial neglect after their stroke, and the severity of such. Spatial neglect is a disorder that may occur after a stroke that leads to a person paying more attention to one side of their body over the other. Each testing session, they will perform paper and pencil neglect tests before and after playing a VR video game that is being designed as a potential future treatment. They will also give feedback on the game after the session is over. People who have spatial neglect after stroke are encouraged to apply.

Study Type

Interventional

Enrollment (Estimated)

10

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

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

Description

Inclusion Criteria:

  • Read and speak English fluently
  • Have a history of one stroke event that injured one cerebral hemisphere
  • Presence of moderate to severe spatial neglect

Exclusion Criteria:

  • History of progressive neurological disorders
  • History of significant psychiatric disorders
  • History of vestibular disorders
  • Living outside a 50-mile radius of Kessler Foundation (located in West Orange, NJ)

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR-based spatial retraining
Game-like therapy activities will be taken place in a virtual environment, provided through an immersive head-mounted display.
Other: VR Therapy Game
Participants will complete 15 sessions of VR-based therapy modules developed for use in helping people with spatial neglect. These 15 sessions will be completed over 4-5 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral Inattention Test
Time Frame: At baseline, after intervention, and two weeks after intervention
A battery of visuospatial tests using paper and pencil to perform line crossing, star cancellation, letter cancellation, line bisection, figure copying, and drawing. The test is scored from 0 to 146, with higher values indicating better performance.
At baseline, after intervention, and two weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Simulator Sickness Questionnaire
Time Frame: After intervention
A 16-item questionnaire asking for adverse feelings related to the virtual reality experience. Example items are eye strain, difficulty concentrating, headache, and burping. Each item is rated none, slight. moderate, or severe.
After intervention
Semi-structured interview
Time Frame: Two weeks after intervention
A 10-minute phone interview will be conducted to explore the subjective experience of the intervention.
Two weeks after intervention

Collaborators and Investigators

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

Sponsor

Kessler Foundation

Investigators

  • Principal Investigator: Peii Chen, PhD, Kessler Foundation

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 (Actual)

March 25, 2019

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 11, 2021

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-996-17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Stroke

Clinical Trials on VR Therapy Game

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe