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 | 2023/03/24 17:13:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
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
| 2023 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050749
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
