Virtual Prism Adaptation Therapy on Hemispatial Neglect

Study Overview
=================
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.

Official Title
-----------------
Effects of Virtual Prism Adaptation Therapy in Stroke Patients With Hemispatial Neglect

Conditions
-----------------
Stroke, Recovery of Function, Rehabilitation, Perceptual Disorders, Virtual Reality Exposure Therapy

Intervention / Treatment
-----------------
* Device: Virtual Prism Adaptation Therapy
* Device: Sham Therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Prism Adaptation Therapy<br>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. | Device: Virtual Prism Adaptation Therapy<br>* Hand trajectory will deviate to the right side in the virtual reality.<br>|
| Sham Comparator: Sham Therapy<br>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. | Device: Sham Therapy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral Inattention Test (BIT) Score | Range: 0(best) to 227(worst) | Change from Baseline at 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BIT Conventional subtest score (BITC) | Range: 0(best) to 146(worst) | Change from Baseline at 5 days | 
| BIT Behavioral subtest score (BITB) | Range: 0(best) to 81(worst) | Change from Baseline at 5 days | 
| Comb and Razor Test | Range: 0% deviation (best) to 100% deviation (worst) | Change from Baseline at 5 days | 
| Catherine Bergego Scale (CBS) | Range: 0 (best) to 30 (worst) | Change from baseline at 5 days |