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Clinical Trials/NCT03771872
NCT03771872
Terminated
Not Applicable

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

Seoul National University Hospital2 sites in 1 country2 target enrollmentDecember 1, 2018
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ConditionsStrokeRecovery of FunctionRehabilitationPerceptual DisordersVirtual Reality Exposure Therapy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Seoul National University Hospital
Enrollment
2
Locations
2
Primary Endpoint
Behavioral Inattention Test (BIT) Score
Status
Terminated
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2018
End Date
February 15, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Won-Seok Kim

Assistant Professor

Seoul National University Hospital

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

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)

Study Sites (2)

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