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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016356
Receipt No. R000018995
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
Date of disclosure of the study information 2015/01/28
Last modified on 2020/08/12

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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