Virtual Prism Adaptation Therapy on Hemispatial Neglect

NCT ID: NCT03771872

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-02-15

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Prism Adaptation Therapy

Intervention Type: DEVICE

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.

Group Type: SHAM_COMPARATOR

Sham Therapy

Intervention Type: DEVICE

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.

Interventions

Virtual Prism Adaptation Therapy

Hand trajectory will deviate to the right side in the virtual reality.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bundang Rusk Rehabilitation Specialty Hospital

UNKNOWN

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Won-Seok Kim

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bundang Rusk Rehabilitation Specialty Hospital

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

2018-0154-004

Identifier Type: -

Identifier Source: org_study_id