UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016356 |
|---|---|
| Receipt number | 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 20:49:50 |
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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
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
kazu_68@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018995
