Virtual Prism Adaptation Therapy on Hemispatial Neglect

Not Applicable

Terminated

• Conditions: Virtual Reality Exposure Therapy; Perceptual Disorders; Recovery of Function; Rehabilitation; Stroke
• Interventions: Device: Sham Therapy; Device: Virtual Prism Adaptation Therapy

• Registration Number: NCT03771872
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2018-12-09
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-11
• Primary Completion: 2020-02-15
• Study Completion: 2020-02-15
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Therapy	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.
Virtual Prism Adaptation Therapy	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.

Primary Outcome Measures

Name	Time	Method
Behavioral Inattention Test (BIT) Score	Change from Baseline at 5 days	Range: 0(best) to 227(worst)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Bundang Rusk Rehabilitation Specialty Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of