Virtual Prism Adaptation Therapy on Hemispatial Neglect

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

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.

Study Overview

• Status: Terminated
• Conditions: Stroke; Rehabilitation; Perceptual Disorders; Recovery of Function; Virtual Reality Exposure Therapy
• Intervention / Treatment: Device: Virtual Prism Adaptation Therapy; Device: Sham Therapy

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13558
      • Bundang Rusk Rehabilitation Specialty Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Prism Adaptation Therapy; 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; Hand trajectory will deviate to the right side in the virtual reality.
Sham Comparator: Sham Therapy; 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; 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.

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Bundang Rusk Rehabilitation Specialty Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): February 15, 2020
• Study Completion (Actual): February 15, 2020

Study Registration Dates

• First Submitted: December 9, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders
• Other Study ID Numbers: 2018-0154-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No