NCT03771872

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

December 9, 2018

Last Update Submit

March 16, 2020

Conditions

StrokeRecovery of FunctionRehabilitationPerceptual DisordersVirtual Reality Exposure Therapy

Outcome Measures

Primary Outcomes (1)

  • Behavioral Inattention Test (BIT) Score

    Range: 0(best) to 227(worst)

    Change from Baseline at 5 days

Secondary Outcomes (4)

  • BIT Conventional subtest score (BITC)

    Change from Baseline at 5 days

  • BIT Behavioral subtest score (BITB)

    Change from Baseline at 5 days

  • Comb and Razor Test

    Change from Baseline at 5 days

  • Catherine Bergego Scale (CBS)

    Change from baseline at 5 days

Study Arms (2)

Virtual Prism Adaptation Therapy

EXPERIMENTAL

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.

Device: Virtual Prism Adaptation Therapy

Sham Therapy

SHAM COMPARATOR

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.

Device: Sham Therapy

Interventions

Virtual Prism Adaptation TherapyDEVICE

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

Virtual Prism Adaptation Therapy
Sham TherapyDEVICE

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.

Sham Therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • months after stroke onset
  • 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
  • points or more in the Korean version of mini-mental state examination

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bundang Rusk Rehabilitation Specialty Hospital

Seongnam-si, Gyeonggi-do, 13558, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

StrokePerceptual Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 9, 2018

First Posted

December 11, 2018

Study Start

December 1, 2018

Primary Completion

February 15, 2020

Study Completion

February 15, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations

KR(2)