UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of repeatability and characteristic of subjective vertical parameter in acute stroke patients -A specific characteristic of acute stroke patients and healthy subjects
Acronym	Investigation of repeatability and characteristic of subjective vertical parameter in acute stroke patients -A specific characteristic of acute stroke patients and healthy subjects
Scientific Title	Investigation of repeatability and characteristic of subjective vertical parameter in acute stroke patients -A specific characteristic of acute stroke patients and healthy subjects
Scientific Title:Acronym	Investigation of repeatability and characteristic of subjective vertical parameter in acute stroke patients -A specific characteristic of acute stroke patients and healthy subjects
Region	Japan

Condition
Condition	acute stroke patients
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate repeatability and characteristic of subjective vertical parameter in acute stroke patients and healthy subjects
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	subjective visual vertical subjective postural vertical subjective postural vertical-eyes open
Key secondary outcomes	bearing surface pressure distribution motion analysis stroke impairment assessment sett trunk control test trunk impairment scale barthel index functional independence measure scale for contraversive pushing burke lateropulsion scale behavioural inattention test

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	stroke patient (1)diagnosis of stroke within previous two months (2)no neurological symptoms (3)no orthostatic hypotention (4)arterial oxygen saturation is 95% and over (5)ability to understand the task helthy subject (1)no history of neurologic or orthopedic problems that would interfere with the ability to perform measurement of vertical axis
Key exclusion criteria	(1)disturbance of consciousness or aphasia that would interfere with the ability to perform measurement of vertical axis (2)history of neurologic or orthopedic problem that would interfere with the ability to perform measurement of vertical axis (3)mental disorder or dementia (4)not able to give informed consent (5)subjects that we judged which participation of this study is unsuitable
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Kazuhiro Middle name Last name Fukata
Organization	Saitama Medical University International Medical Center
Division name	Department of Rehabilitation
Zip code	350-1298
Address	1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
TEL	042-984-4367
Email	kazu_68@saitama-med.ac.jp

Public contact
Name of contact person	1st name Kazuhiro Middle name Last name Fukata
Organization	Saitama Medical University International Medical Center
Division name	Department of Rehabilitation
Zip code	350-1298
Address	1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
TEL	042-984-4367
Homepage URL
Email	kazu_68@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University International Medical Center
Institute
Department

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	Saitama International University International Medical Center
Address	1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
Tel	0429844367
Email	fkazuhiro.68@gmail.com

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	2015 Year 01 Month 28 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	43
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	2015 Year 01 Month 27 Day
Date of IRB	2015 Year 02 Month 07 Day
Anticipated trial start date	2015 Year 02 Month 07 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	prospective cohort study

Management information
Registered date	2015 Year 01 Month 27 Day
Last modified on	2020 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018995