UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011600 |
|---|---|
| Receipt number | R000013566 |
| Scientific Title | Stroke rehabilitation database for structural and functional brain imaging, and electrophysiological and behavioral measurements |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2013/08/29 17:40:26 |
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Basic information
Public title
Stroke rehabilitation database for structural and functional brain imaging, and electrophysiological and behavioral measurements
Acronym
Stroke rehabilitation database for brain function
Scientific Title
Stroke rehabilitation database for structural and functional brain imaging, and electrophysiological and behavioral measurements
Scientific Title:Acronym
Stroke rehabilitation database for brain function
Region
| Japan |
Condition
Condition
Hemiplegic stroke patients and healthy adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our goal is to elucidate the changes in brain function and structure accompanied by the process of functional recovery during the post stroke sub-acute rehabilitation period. Through this, we would contribute to the proposal of novel rehabilitation methods that would effectively facilitate the functional recovery.
Basic objectives2
Others
Basic objectives -Others
longitudinal observation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MRI image (T1, T2, DTI), fMRI image, functional assessments (Fugl-Meyer assessment, SIAS, BBT, TUG, 10m walk, etc)
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[Patients]
First ever stroke
Oral nutrition
No communication difficulty
Consent to participate in the study
[Healthy adults]
Consent to participate in the study
Key exclusion criteria
[Patients and healthy adults]
Contraindication to MRI
Severe cognitive disturbance
[Healthy adults]
Taking psychiatric medicine
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rieko Osu |
Organization
Advanced Telecommunications Research Institute International
Division name
Brain Information Communication Research Laboratory Group
Zip code
Address
2-2-2 Hikaridai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
0774-95-1221
osu@atr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Otaka |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation Research
Zip code
Address
4-1-1 Yatsu, Narashino, Chiba, Japan
TEL
047-453-9000
Homepage URL
otaka119@mac.com
Sponsor or person
Institute
Advanced Telecommunications Research Institute International
Institute
Department
Personal name
Funding Source
Organization
Funding Program for Next Generation World-Leading Researchers
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 09 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigate the relationship among affected area, severeness of the impairment, magnitude of recovery, and changes in brain structural (VBM, FA etc) and functional (resting state network etc) parameters.
Management information
Registered date
| 2013 | Year | 08 | Month | 29 | Day |
Last modified on
| 2013 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013566
