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Virtual Prism Adaptation Therapy on Hemispatial Neglect

Primary Purpose

Stroke, Recovery of Function, Rehabilitation

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Virtual Prism Adaptation Therapy
Sham Therapy
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 3 months after stroke onset
  • 2 or more tests indicative of hemispatial neglect in following 3 tests: 1)line bisection test, 2)Albert's test, 3)Drawing test.
  • Ability to recognize the target object, hand trajectory in the immersive virtual reality
  • 16 points or more in the Korean version of mini-mental state examination

Exclusion Criteria:

  • Previous stroke or traumatic brain injury history
  • Can not cooperate during the therapy, due to delirium or aphasia
  • Unstable medical conditions
  • Severe psychiatric symptoms that interfere with the therapy participation (e.g. severe depression, agitation, psychotic symptoms)
  • Pregnancy
  • Can not maintain sitting posture

Sites / Locations

  • Bundang Rusk Rehabilitation Specialty Hospital
  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Virtual Prism Adaptation Therapy

Sham Therapy

Arm Description

This group will be provided with real virtual prism adaptation therapy. In the real therapy session, the hand trajectory will deviate to the right side in the virtual reality. The deviation angle will be adjusted according to the subject's adaptation. 20min-session will be provided twice a day for 5 days, then the total 10 sessions of therapy will be provided.

The therapy is the same as the real virtual prism adaptation therapy, but there will be no deviation of the hand trajectory in the virtual reality.

Outcomes

Primary Outcome Measures

Behavioral Inattention Test (BIT) Score
Range: 0(best) to 227(worst)

Secondary Outcome Measures

BIT Conventional subtest score (BITC)
Range: 0(best) to 146(worst)
BIT Behavioral subtest score (BITB)
Range: 0(best) to 81(worst)
Comb and Razor Test
Range: 0% deviation (best) to 100% deviation (worst)
Catherine Bergego Scale (CBS)
Range: 0 (best) to 30 (worst)

Full Information

First Posted
December 9, 2018
Last Updated
March 16, 2020
Sponsor
Seoul National University Hospital
Collaborators
Bundang Rusk Rehabilitation Specialty Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03771872
Brief Title
Virtual Prism Adaptation Therapy on Hemispatial Neglect
Official Title
Effects of Virtual Prism Adaptation Therapy in Stroke Patients With Hemispatial Neglect
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Recruitment of subjects has been difficult.
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
February 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Bundang Rusk Rehabilitation Specialty Hospital

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to investigate the effect of virtual prism adaptation therapy on hemispatial neglect in chronic stroke patients. This study is the randomized, double-blind, sham-controlled, cross-over design. Total 10 patients will be allocated randomly to either real virtual prism adaptation therapy or sham therapy with the wash-out period of more than 2 weeks. Two sessions (20min/session) per day, for 5days (total 10 sessions) will be provided. Behavioral outcomes will be measured before and after completing a total of 10 sessions therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Recovery of Function, Rehabilitation, Perceptual Disorders, Virtual Reality Exposure Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Prism Adaptation Therapy
Arm Type
Experimental
Arm Description
This group will be provided with real virtual prism adaptation therapy. In the real therapy session, the hand trajectory will deviate to the right side in the virtual reality. The deviation angle will be adjusted according to the subject's adaptation. 20min-session will be provided twice a day for 5 days, then the total 10 sessions of therapy will be provided.
Arm Title
Sham Therapy
Arm Type
Sham Comparator
Arm Description
The therapy is the same as the real virtual prism adaptation therapy, but there will be no deviation of the hand trajectory in the virtual reality.
Intervention Type
Device
Intervention Name(s)
Virtual Prism Adaptation Therapy
Intervention Description
Hand trajectory will deviate to the right side in the virtual reality.
Intervention Type
Device
Intervention Name(s)
Sham Therapy
Intervention Description
The therapy is the same as the real virtual prism adaptation therapy, but there will be no deviation of the hand trajectory in the virtual reality.
Primary Outcome Measure Information:
Title
Behavioral Inattention Test (BIT) Score
Description
Range: 0(best) to 227(worst)
Time Frame
Change from Baseline at 5 days
Secondary Outcome Measure Information:
Title
BIT Conventional subtest score (BITC)
Description
Range: 0(best) to 146(worst)
Time Frame
Change from Baseline at 5 days
Title
BIT Behavioral subtest score (BITB)
Description
Range: 0(best) to 81(worst)
Time Frame
Change from Baseline at 5 days
Title
Comb and Razor Test
Description
Range: 0% deviation (best) to 100% deviation (worst)
Time Frame
Change from Baseline at 5 days
Title
Catherine Bergego Scale (CBS)
Description
Range: 0 (best) to 30 (worst)
Time Frame
Change from baseline at 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 3 months after stroke onset 2 or more tests indicative of hemispatial neglect in following 3 tests: 1)line bisection test, 2)Albert's test, 3)Drawing test. Ability to recognize the target object, hand trajectory in the immersive virtual reality 16 points or more in the Korean version of mini-mental state examination Exclusion Criteria: Previous stroke or traumatic brain injury history Can not cooperate during the therapy, due to delirium or aphasia Unstable medical conditions Severe psychiatric symptoms that interfere with the therapy participation (e.g. severe depression, agitation, psychotic symptoms) Pregnancy Can not maintain sitting posture
Facility Information:
Facility Name
Bundang Rusk Rehabilitation Specialty Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13558
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Virtual Prism Adaptation Therapy on Hemispatial Neglect

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