UMIN-CTR Clinical Trial

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
Email	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
Email	s-iio@sis.seirei.or.jp

Sponsor
Institute	Hamamatsu City Rehabilitation Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040839