UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044426 |
|---|---|
| Receipt number | R000050749 |
| Scientific Title | Effects of Virtual Reality and Visual Search Interventions on voluntary, reorienting of attention in patients with subacute left unilateral spatial neglect |
| Date of disclosure of the study information | 2021/06/05 |
| Last modified on | 2024/09/20 09:04:03 |
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Basic information
Public title
Effects of Virtual Reality and Visual Search Interventions on voluntary, reorienting of attention in patients with subacute left unilateral spatial neglect
Acronym
Effects of Virtual Reality and Visual Search Interventions on voluntary, reorienting of attention in patients with left unilateral spatial neglect
Scientific Title
Effects of Virtual Reality and Visual Search Interventions on voluntary, reorienting of attention in patients with subacute left unilateral spatial neglect
Scientific Title:Acronym
Effects of Virtual Reality and Visual Search Interventions on voluntary, reorienting of attention in patients with left unilateral spatial neglect
Region
| Japan |
Condition
Condition
storke
Classification by specialty
| Neurology | Vascular surgery | Neurosurgery |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of Virtual Reality and Visual Search Interventions on voluntary, reorienting of attention in patients with left unilateral spatial neglect
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Behavioral Inattention Test,
Catherine Bergego Scale,
Modified Posner tasks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Intervention condition
Intervention to quickly track balloons using a head-mounted display.
(Intervention period: 2 weeks, 5 times a week, 10 minutes a day)
Interventions/Control_2
Control condition
Intervention to search for 50 numbers.
(Intervention period: 2 weeks, 5 times a week, 10 minutes a day)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with stroke due to right hemisphere injury with unilateral spatial neglect (Behavioral Inattention Test <131 points).
Mini Mental State Examination 16 points or more
Key exclusion criteria
Left hemisphere stroke patient, bilateral lesions
Persons with a history of stroke
Left-handed person
Severe aphasia or dementia diagnosed and unable to follow instructions
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Shinpei |
| Middle name | |
| Last name | Osaki |
Organization
Kansai Electric Power Hospital
Division name
Department of rehabilitation
Zip code
553-0003
Address
2-1-7 Fukushima, Fukushima-ku, Osaka
TEL
06-6458-5821
osaki.shimpei@b2.kepco.co.jp
Public contact
Name of contact person
| 1st name | Shinpei |
| Middle name | |
| Last name | Osaki |
Organization
Kansai Electric Power Hospital
Division name
Department of rehabilitation
Zip code
553-0003
Address
2-1-7 Fukushima, Fukushima-ku, Osaka
TEL
06-6458-5821
Homepage URL
osaki.shimpei@b2.kepco.co.jp
Sponsor or person
Institute
Kansai Electric Power Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Electric Power Hospital
Address
2-1-7 Fukushima,Fukushima-ku,Osaka
Tel
06-6458-5821
osaki.shimpei@b2.kepco.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/37478380/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37478380/
Number of participants that the trial has enrolled
28
Results
Outcomes were changes in scores on Catherine Bergego Scale (CBS) and reaction time on the modified Posner task (MPT). There was significant improvement in CBS score change after VR balloon retrieval training. In the invalid condition of MPT, significant improvements were shown after VR balloon search training in left-sided reaction time (improvement of stimulation-driven attention).
Results date posted
| 2024 | Year | 09 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Inclusion criteria were as follows: (1) first-ever stroke, (2) no severe cognitive impairment (Mini-Mental State Examination), (3) right hemisphere brain lesion, and (4) at least a score below the cutoff value in one item of the standard test for the behavioural inattention test conventional subtests (BIT-c).
Exclusion criteria were as follows: (1) left hemisphere brain lesion, (2) bilateral lesions, (3) previous stroke, (4) Aphasia or other cognitive impairments, (5) disturbance of consciousness, and (6) patients refusal to participate.
Participant flow
We recruited participants from the Rehabilitation Department of our Hospital between January 2020 and December 2021. Patients were screened at the point of admission to the rehabilitation department within the hospital. The participants were divided into two groups: immediate VR group (n=14) and delayed VR group (n=14).
Adverse events
none in particular
Outcome measures
(1) Behavioural Inattention test conventional subtests (BIT-c) were used to determine USN. A line cancellation test, copying test, line bisection test, and drawing test are included in the basic evaluation. The total score is 146 points.
(2) The Catherine Bergego Scale (CBS) is an observation scale for assessment of neglect in 10 real-life situations/tasks, and is administered by a blinded physical therapist, occupational therapist, and nurse. Each item of the 10 categories in CBS attracts a score of either 0 (no neglect) or 3 (severe neglect); the maximum total score is 30 points.
(3) The modified Posner task (MPT) is a neuropsychological test used to assess changes in attention. This task reacts to the target displayed in either the left or right position.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 04 | Day |
Last modified on
| 2024 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050749
