UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059206 |
|---|---|
| Receipt number | R000067716 |
| Scientific Title | Effects of Virtual Reality-Based Sitting Balance Intervention on Subjective Postural Verticality and Brain Activity Dynamics |
| Date of disclosure of the study information | 2025/09/26 |
| Last modified on | 2025/09/26 16:01:10 |
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Basic information
Public title
Effects of Virtual Reality-Based Sitting Balance Intervention on Subjective Postural Verticality and Brain Activity Dynamics
Acronym
Effects of Virtual Reality-Based Sitting Balance Intervention on Subjective Postural Verticality and Brain Activity Dynamics
Scientific Title
Effects of Virtual Reality-Based Sitting Balance Intervention on Subjective Postural Verticality and Brain Activity Dynamics
Scientific Title:Acronym
Effects of Virtual Reality-Based Sitting Balance Intervention on Subjective Postural Verticality and Brain Activity Dynamics
Region
| Japan |
Condition
Condition
Patients with Stroke in hemiplegia, Pusher behavior and unilateral spatial neglect
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is designed to develop VR-based assessment and intervention methods for SPV-EO and elucidate brain activity dynamics using fNIRS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective Postural Vertical with Eyes Closed, SPV with Eyes Opened, Functional Near-infrared spectroscopy (fNIRS)
Key secondary outcomes
FIST, SCP, FIM, FMA, SIAS, BBS, CBS, BIT, TUG, FES-I
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Conventional intervention
Interventions/Control_2
Experimental intervention using Virtual Reality
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
No impairment of consciousness.
Ability to understand study instructions and provide written informed consent.
Presence of a unilateral supratentorial lesion.
Diagnosis of stroke hemiplegia, Pusher syndrome, or unilateral spatial neglect.
Stable neurological and medical condition/symptoms at the time of enrollment.
Key exclusion criteria
Severe dementia or aphasia that significantly impairs communication.
Diagnosis of neurodegenerative diseases (e.g., Parkinson's disease).
Unstable neurological symptoms or currently undergoing treatment that may interfere with study results.
Inability to understand or provide written informed consent.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Sawa |
Organization
SBC Tokyo Medical University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
279-8567
Address
5-8-1 Akemi, Urayasu, Chiba, Japan
TEL
08012079205
k-sawa@sbctmu.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Sawa |
Organization
SBC Tokyo Medical University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
279-0014
Address
5-8-1 Akemi, Urayasu, Chiba, Japan
TEL
08012079205
Homepage URL
k-sawa@sbctmu.ac.jp
Sponsor or person
Institute
SBC Tokyo Medical University
Institute
Department
Personal name
Kota Sawa
Funding Source
Organization
SBC Tokyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SBC Tokyo Medical University
Address
5-8-1 Akemi, Urayasu, Chiba, Japan
Tel
08012079205
k-sawa@sbctmu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
23-11
Org. issuing International ID_1
SBC Tokyo Medical University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Tiba [Chiba]
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 09 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067716
