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Clinical Trials/NCT03771872
NCT03771872TerminatedNot Applicable

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

Seoul National University Hospital4 sites in 1 country2 target enrollmentStarted: December 1, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
2
Locations
4
Primary Endpoint
Behavioral Inattention Test (BIT) Score
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Behavioral Inattention Test (BIT) Score

Time Frame: Change from Baseline at 5 days

Range: 0(best) to 227(worst)

Secondary Outcomes

  • Comb and Razor Test(Change from Baseline at 5 days)
  • BIT Conventional subtest score (BITC)(Change from Baseline at 5 days)
  • BIT Behavioral subtest score (BITB)(Change from Baseline at 5 days)
  • Catherine Bergego Scale (CBS)(Change from baseline at 5 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Won-Seok Kim

Assistant Professor

Seoul National University Hospital

Study Sites (4)

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