Virtual Prism Adaptation Therapy on Hemispatial Neglect

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03771872
• Other study ID #: 2018-0154-004
• Status: Terminated
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: February 15, 2020

Study information

• Verified date: March 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 15, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Perceptual Disorders
• Recovery of Function
• Rehabilitation
• Stroke
• Virtual Reality Exposure Therapy

Intervention

Device:
• Virtual Prism Adaptation Therapy
Hand trajectory will deviate to the right side in the virtual reality.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Bundang Rusk Rehabilitation Specialty Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Bundang Rusk Rehabilitation Specialty Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral Inattention Test (BIT) Score	Range: 0(best) to 227(worst)	Change from Baseline at 5 days
Secondary	BIT Conventional subtest score (BITC)	Range: 0(best) to 146(worst)	Change from Baseline at 5 days
Secondary	BIT Behavioral subtest score (BITB)	Range: 0(best) to 81(worst)	Change from Baseline at 5 days
Secondary	Comb and Razor Test	Range: 0% deviation (best) to 100% deviation (worst)	Change from Baseline at 5 days
Secondary	Catherine Bergego Scale (CBS)	Range: 0 (best) to 30 (worst)	Change from baseline at 5 days