NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032200451

Registered date:31/03/2021

The study comparing the conventional test and using the immersive VR method

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedstroke (cerebral infarction, cerebral hemorrhage)
Date of first enrollment08/04/2022
Target sample size40
Countries of recruitment
Study typeInterventional
Intervention(s)After performing MMSE, confirmation of dominant hand, Barthel Index, and Behavioural inattention test, the subjects performe the line bisection test using the immersive VR method in a VR space (width 12m, depth 12m, height 4.5m). The line bisection test is consisted of 8 different distances, 0.25m, 0.50m, 1 peripersonal length, 1.00m, 2 peripersonal length, 2.00m, 3.00m, 4.00m) and eight different lengths (thickness), 0.1m(1mm), 0.2m(0.2mm), 0.4m(4mm), 0.8m(8mm),1.2m(12mm),1.6m(16mm), 1peripesonal length(0.01 peripersonal length), 2 peripersonal length(0.02 peripersonal length). As 1 peripersonal length, we use the length from the acromion to the metacarpal head of index finger on the subjects dominant hand side.The subjects performe the line bisection test using the immersive VR method in sequence from the peripersonal space to the extrapersonal space at each distance. The procedure for the line bisection test was set with reference to the previous study by Cowey A et al (1999). The measurement position of subjects are a chair sitting position or wheelchair sitting position, and the posture be comfortable. The line segment is adjusterd to the front, midline and eye level of each subject for each test. In order to familiarize the subjects with use the device, the subjects confirms the operation of the controller with dominant hand and starts the line bisection test. It is displayed as a point on whiteboard in the VR space according to the movement of the controller operated by the subjects. The subjects can draw a line as pulling the trigger on the controller. During the test, we take a break while considering the physical condition od subject.

Outcome(s)

Primary OutcomeComparison of the Behavioural Inattention Test and the assessment using the immersive VR method
Secondary Outcome1) Deviation of the line bisection 2) Gaze distribution of the horizontal direction 3) Questionarie of the VR sickness

Key inclusion & exclusion criteria

Age minimum>= 40age old
Age maximum<= 79age old
GenderBoth
Include criteriapatient group 1) with ages ranging from 40 to 79. 2) male and female. 3) presence of a first-time right hemisphere stroke (cerebral infarction or cerebral hemorrhage). 4) even if the patients have aphasia, they can understand the instructions and perform the tests. 5) more than 2 weeks after onset and be in a stable condition. 6) can sit independently on chair or in wheelchair. 7) signed informed patients or family consent. healthy group 1) with ages ranging from 40 to 79. 2) male and female. 3) signed informed subjects or family consent.
Exclude criteriapatient group 1) a history of major neurological disorders other than stroke. 2) a history of major psychiatric disorders. 3) with head injury. 4) with disturbance of consciousness. 5) with cognitive disorders (the score of Mini-Mental State Examination under 23). 6) presence of visual impairment (e.g. visual field deficit, damage to the optic radiation and the occipital lobe). 7) judged to be unsuitable to the assessment by doctors in the team. The study was approved by the local ethics committee at the hospital, and written informed consent was obtained from all subjects. healthy group 1) a history of major neurological disorders other than stroke. 2) a history of major psychiatric disorders. 3) with head injury. 4) with disturbance of consciousness. 5) with cognitive disorders (the score of Mini-Mental State Examination under 23). 6) presence of visual impairment (e.g. visual field deficit, damage to the optic radiation and the occipital lobe). 7) judged to be unsuitable to the assessment by doctors in the team. The study was approved by the local ethics committee at the hospital, and written informed consent was obtained from all subjects.

Related Information

Contact

Public contact
Name Masayuki Tazawa
Address 3-39-15 Showa, Maebashi, Gunma, 371-8511 Gunma Japan 371-8511
Telephone +81-27-220-8532
E-mail mastaz1@gunma-u.ac.jp
Affiliation Gunma University Graduate School of Medicine
Scientific contact
Name Naoki Wada
Address 3-39-15 Showa, Maebashi, Gunma, 371-8511 Gunma Japan 371-8511
Telephone +81-27-220-8532
E-mail nwada@gunma-u.ac.jp
Affiliation Gunma University Graduate School of Medicine