NCT04714645

Brief Summary

The aim of this study is to examine the effect of an additional VR training program on unilateral spatial neglect (USN) after stroke. Principally, clinical assessment of the presence of unilateral spatial neglect and additionally the severity of USN will be measured using the Behavioral Inattention test (BIT), using only the BIT Conventional subtest (BITC). Secondarily, the VR outcomes will be included as well. Finally, we want to determine if the effects last over a short period of time. It is important to know whether the potential effects of the VR-training remain without continuing the intervention. Therefore, we will perform a follow-up assessment after 1 week.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

1.9 years

First QC Date

January 11, 2021

Last Update Submit

May 9, 2022

Conditions

StrokeNeglect

Keywords

virtual realityneglectstrokeintervention

Outcome Measures

Primary Outcomes (1)

  • BITC test

    The BITC test will be taken before, immediately after and 1-week after the intervention.

    through study completion, i.e. 12 days

Secondary Outcomes (3)

  • VR specific outcome: head rotations

    through study completion, i.e. 12 days

  • VR specific outcome: time

    through study completion, i.e. 12 days

  • VR specific outcome: number of errors

    through study completion, i.e. 12 days

Study Arms (2)

Intervention group

EXPERIMENTAL

VR+ training

Device: VR neglect training

Control group

SHAM COMPARATOR

VR- training

Device: VR control training

Interventions

VR neglect trainingDEVICE

Patients will undergo 1 session a day for 30 minutes for 5 consecutive days. The training consists of 5 different VR tasks specifically designed for neglect training.

Intervention group
VR control trainingDEVICE

Patients will undergo 1 session a day for 30 minutes for 5 consecutive days. This is a placebo training, where patients will also wear the HMD. Patients will be immersed in a virtual environment without a specific task.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a right-hemisphere hemorrhagic or ischemic stroke, confirmed by CT or MRI
  • only subacute (\>2 weeks) and chronic (\>6 months) unilateral spatial neglect patients
  • scoring below the cut-off value of 129 points on the standard BITC test
  • being 18 years or older at the time of lesion

You may not qualify if:

  • patients with dementia (Mini Mental State Examination (MMSE) \< 24) or aphasia (Mississippi Aphasia Screening Test (MAST) \< 45)
  • patients whose visual or hearing impairment does not allow possibility of interaction with the VR system
  • patients with depression (Patient Health Questionnaire (PHQ-9) \>= 10)
  • patients unable to sit for at least 30 minutes in a wheelchair or chair
  • patients with sensorimotor alterations that can interfere with the performance with the VR system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Brussel

Brussels, 1050, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Eva Swinnen, Prof. Ph.D

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
There will be an external assessor, who will be blinded during the clinical assessments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 19, 2021

Study Start

February 15, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 10, 2022

Record last verified: 2022-05

Locations

BE(1)