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

Sponsor
Kessler Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT04793516
Collaborator
(none)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: VR Therapy Game
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Development of a Virtual Reality Spatial Retraining Therapy to Improve Neglect in Stroke Survivors
Actual Study Start Date :
Mar 25, 2019
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. Semi-structured interview [Two weeks after intervention]

    A 10-minute phone interview will be conducted to explore the subjective experience of the intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kessler Foundation West Orange New Jersey United States 07052

Sponsors and Collaborators

  • Kessler Foundation

Investigators

  • Principal Investigator: Peii Chen, PhD, Kessler Foundation

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Peii Chen, Senior Research Scientist, PI, Kessler Foundation
ClinicalTrials.gov Identifier:
NCT04793516
Other Study ID Numbers:
  • E-996-17
First Posted:
Mar 11, 2021
Last Update Posted:
Apr 7, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022