UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051690 |
|---|---|
| Receipt number | R000058989 |
| Scientific Title | A new assessment of postural vertical in the eyes closed and opened, and effects of vertical perception in Virtual Reality: an observational study and a randomized crossover trials |
| Date of disclosure of the study information | 2023/07/23 |
| Last modified on | 2024/05/25 17:57:10 |
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Basic information
Public title
A new assessment of postural vertical in the eyes closed and opened, and effects of vertical perception in Virtual Reality: an observational study and a randomized crossover trials
Acronym
A new assessment of postural vertical in the eyes closed and opened, and effects of vertical perception in Virtual Reality: an observational study and a randomized crossover trials
Scientific Title
A new assessment of postural vertical in the eyes closed and opened, and effects of vertical perception in Virtual Reality: an observational study and a randomized crossover trials
Scientific Title:Acronym
A new assessment of postural vertical in the eyes closed and opened, and effects of vertical perception in Virtual Reality: an observational study and a randomized crossover trials
Region
| Japan |
Condition
Condition
Healthy participants and stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this research are to (1) develop an SPV evaluation and (2) determine what impact SPV has in Virtual Reality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Phase I,II
Assessment
Primary outcomes
Evaluate SPV-EO and SPV using conventional motorized vertical perception measuring devices and digital angle meters (applications).
Key secondary outcomes
Trunk control test, functional in sitting test, berg balance test, functional independence measure, center of pressure
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
Intervention of vertical cognition through visual feedback using VR
Interventions/Control_2
Visual and behavioral training using VR
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
| 19 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants meet the inclusion criteria of being able to sit when observing a person and having suffered their first stroke.
Key exclusion criteria
The exclusion criteria were as follows: brainstem lesions, cerebellar lesions, multiple cerebral infarctions, hydrocephalus, poor instruction comprehension, and orthopedic history.
Target sample size
52
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
2798567
Address
Akemi, Urayasu City, Chiba, 5-8-1
TEL
+818012079205
koutas966@gmail.com
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
2798567
Address
Akemi, Urayasu City, Chiba, 5-8-1
TEL
+818012079205
Homepage URL
k-sawa@ryotokuji-u.ac.jp
Sponsor or person
Institute
SBC Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
SBC Tokyo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Society for the Promotion of Science
IRB Contact (For public release)
Organization
SBC Tokyo Medical University
Address
Akemi, Urayasu City, Chiba, 5-8-1
Tel
+818012079205
k-sawa@ryotokuji-u.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
| 2023 | Year | 07 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 22 | Day |
Last modified on
| 2024 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058989
