Development of a Virtual Reality Spatial Retraining Therapy to Improve Neglect in Stroke Survivors

Not Applicable

Recruiting

• Conditions: Stroke; Spatial Neglect
• Interventions: Other: VR Therapy Game

• Registration Number: NCT04793516
• Lead Sponsor: Kessler Foundation

Brief Summary

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.

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 Timeline

• Study Start: 2019-03-25
• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-11
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-05
• Primary Completion: 2024-07-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VR-based spatial retraining	VR Therapy Game	Game-like therapy activities will be taken place in a virtual environment, provided through an immersive head-mounted display.

Primary Outcome Measures

Name	Time	Method
Behavioral Inattention Test	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.

Secondary Outcome Measures

Name	Time	Method
Semi-structured interview	Two weeks after intervention	A 10-minute phone interview will be conducted to explore the subjective experience of the intervention.
Simulator Sickness Questionnaire	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.

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States