UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046929 |
|---|---|
| Receipt number | R000053427 |
| Scientific Title | Effects of intervention using virtual reality with biasing background on standing balance and spatial cognition in right hemisphere stroke patients -a randomized controlled trial- |
| Date of disclosure of the study information | 2022/02/16 |
| Last modified on | 2023/12/20 22:45:13 |
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Basic information
Public title
Effects of intervention using virtual reality with biasing background on standing balance and spatial cognition in right hemisphere stroke patients
-a randomized controlled trial-
Acronym
Effects of intervention using virtual reality with biasing background on standing balance and spatial cognition in right hemisphere stroke patients
-a randomized controlled trial-
Scientific Title
Effects of intervention using virtual reality with biasing background on standing balance and spatial cognition in right hemisphere stroke patients
-a randomized controlled trial-
Scientific Title:Acronym
Effects of intervention using virtual reality with biasing background on standing balance and spatial cognition in right hemisphere stroke patients
-a randomized controlled trial-
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of virtual reality with biasing background on standing balance and spatial cognition in right hemisphere stroke patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Standing balance(MX, MY, RMS)
Key secondary outcomes
Berg Balance Scale
Reaction time of visual search task
Subjective Straight Ahead
Timed up and Go test
Subjective visual vertical
Fugl-Meyer assessment
Stroke Impairment Assessment Set
Functional Independence Measure
Trunk Control Test
Frequency analysis
Kinematic analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Experimental group
Visual search task in virtual reality with biasing background
(32 times per session, 7 sessions a week)
Interventions/Control_2
Experimental group
Visual search task in virtual reality with fixed background
(32 times per session, 7 sessions a week)
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
1)first onset of stroke
2)from 2 weeks to 6 months from onset
3)supratentorial lesion
4)over 20 years old
5)right handed
6)stable of neurological conditions
7)no vestibular diseases
8)having an unilateral hemiparesis
9)signed informed consent
Key exclusion criteria
1)cannot understand the instruction
2)having mental disease or dementia
3)cannot execute the task due to orthopedic disease
4)Bilateral lesions
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazushige |
| Middle name | |
| Last name | Iwakawa |
Organization
Saiseikai Higashi-Kanagawa Rehabilitation Hospital
Division name
Department of Rehabilitation Therapists
Zip code
221-0822
Address
1-13-10, Nishi-Kanagawa, Kanagawa-Ku, Yokohama, Kanagawa
TEL
045-324-3600
iwakawa-kazushige@ed.tmu.ac.jp
Public contact
Name of contact person
| 1st name | Kazushige |
| Middle name | |
| Last name | Iwakawa |
Organization
Saiseikai Higashi-Kanagawa Rehabilitation Hospital
Division name
Department of Rehabilitation Therapists
Zip code
221-0822
Address
1-13-10, Nishi-Kanagawa, Kanagawa-Ku, Yokohama, Kanagawa
TEL
045-324-3600
Homepage URL
iwakawa-kazushige@ed.tmu.ac.jp
Sponsor or person
Institute
Saiseikai Higashi-Kanagawa Rehabilitation 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
Saiseikai Higashi-Kanagawa Rehabilitation Hospital
Address
1-13-10, Nishi-Kanagawa, Kanagawa-Ku, Yokohama, Kanagawa
Tel
045-324-3600
iwakawa-kazushige@ed.tmu.ac.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
| 2022 | Year | 02 | Month | 16 | 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
24
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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 02 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053427
