UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036407 |
|---|---|
| Receipt number | R000040839 |
| Scientific Title | The relationship between misperception of orientation and postural disorder in stroke patients and the neural basis |
| Date of disclosure of the study information | 2019/04/08 |
| Last modified on | 2022/02/12 19:03:09 |
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Basic information
Public title
The relationship between misperception of orientation and postural disorder in stroke patients and the neural basis
Acronym
The study for misperception of orientation in stroke patients
Scientific Title
The relationship between misperception of orientation and postural disorder in stroke patients and the neural basis
Scientific Title:Acronym
The study for misperception of orientation in stroke patients
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the relationship between misperception of orientation and postural disorder in stroke patient and to identify the brain region contributing to the perceiton of orientation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective visual vertical (SVV)
Subjective visual body axis (SVBA)
Key secondary outcomes
center of pressure
Postural assessment scale for stroke (PASS)
Stroke impairment assessment set (SIAS)
MRI image (T1 and T2)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Head MRI (T1 and T2)
Interventions/Control_2
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stroke patients
1. Age between 20 and 89 years old
2. Clinically incipient stroke (cerebral hemorrhage or infarction) patients
3. Right-handedness before onset of stroke
4. Individuals who could be assessed with behaviral tests and head-MRI scan wihtin 3 months after onset
5. Indivisuals who can sit without support for more than 30 seconds
6. Capability of informed consent based on their own or their family's decision
Key exclusion criteria
1. Individuals with lesions in both hemispheres, cerebellum or brainstem
2. Individuals with difficulties to understand or excute the behaviral tasks due to a serious dementia, attentional disorder, apraxia, visual field defect, aphasia, or mental disorder.
3. Individuals with a history or organic disease in nervous system such as spinal injuly or peripheral nerve disease
4. Individuals with a serious musculoskeletal disorder
5. Individuals with a organic vestibular disease
6. Indivisuals with dizziness or vertigo, or strong motion sickness
7. Individuals who are unable to undergo MRI
8. Individuals that researchers decide that they are inappropriate for study participation.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Iio |
Organization
Hamamatsu City Rehabilitation Hospital
Division name
Division of Rehabilitation
Zip code
433-8127
Address
1-6-1 Wagoukita Hamamatsu, Shizuoka, JAPAN
TEL
053-471-8331
s-iio@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Iio |
Organization
Hamamatsu City Rehabilitation Hospital
Division name
Division of Rehabilitation
Zip code
433-8127
Address
1-6-1 Wagoukita Hamamatsu, Shizuoka, JAPAN
TEL
053-471-8331
Homepage URL
s-iio@sis.seirei.or.jp
Sponsor or person
Institute
Hamamatsu City Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu City Rehabilitation Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JP
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu City Rehabilitation Hospital
Address
1-6-1 Wagoukita Hamamatsu, Shizuoka, JAPAN
Tel
053-471-8331
s-iio@sis.seirei.or.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
浜松市リハビリテーション病院、浜松医科大学
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 08 | 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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 04 | Month | 04 | Day |
Last modified on
| 2022 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040839
