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

Primary Purpose

Stroke, Spatial Neglect

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VR Therapy Game
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Kessler FoundationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VR-based spatial retraining

Arm Description

Game-like therapy activities will be taken place in a virtual environment, provided through an immersive head-mounted display.

Outcomes

Primary Outcome Measures

Behavioral Inattention Test
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

Simulator Sickness Questionnaire
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.
Semi-structured interview
A 10-minute phone interview will be conducted to explore the subjective experience of the intervention.

Full Information

First Posted
March 4, 2021
Last Updated
June 2, 2023
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04793516
Brief Title
Development of a Virtual Reality Spatial Retraining Therapy to Improve Neglect in Stroke Survivors
Acronym
VR-SRT
Official Title
Development of a Virtual Reality Spatial Retraining Therapy to Improve Neglect in Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spatial Neglect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VR-based spatial retraining
Arm Type
Experimental
Arm Description
Game-like therapy activities will be taken place in a virtual environment, provided through an immersive head-mounted display.
Intervention Type
Other
Intervention Name(s)
VR Therapy Game
Intervention Description
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.
Primary Outcome Measure Information:
Title
Behavioral Inattention Test
Description
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.
Time Frame
At baseline, after intervention, and two weeks after intervention
Secondary Outcome Measure Information:
Title
Simulator Sickness Questionnaire
Description
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.
Time Frame
After intervention
Title
Semi-structured interview
Description
A 10-minute phone interview will be conducted to explore the subjective experience of the intervention.
Time Frame
Two weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Kaplan
Phone
973-243-6880
Email
ekaplan@kesslerfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peii Chen, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Kaplan
Phone
973-243-6880
Email
ekaplan@kesslerfoundation.org

12. IPD Sharing Statement

Learn more about this trial

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

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