UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009344 |
|---|---|
| Receipt number | R000010975 |
| Scientific Title | MRI study on motor recovery after stroke |
| Date of disclosure of the study information | 2012/11/16 |
| Last modified on | 2013/11/18 16:36:56 |
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Basic information
Public title
MRI study on motor recovery after stroke
Acronym
MRI study on stroke recovery
Scientific Title
MRI study on motor recovery after stroke
Scientific Title:Acronym
MRI study on stroke recovery
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to facilitate functional recovery after stroke by providing MRI neuro-feedback information while performing motor tasks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Grip force, Fugl-Meyer Assessment, Finger tapping, Action Research Arm Test, 9 hole peg test
Key secondary outcomes
Functional Independence Measure, Modified Ashworth Scale, Motor Activity Log
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Performing motor tasks with feedback about subjects' own brain activation for 2 days within a week
Interventions/Control_2
Performing motor tasks without feedback about subjects' own brain activation for 2 days within a week
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with first-ever stroke
patients with motor paresis who can perform gross finger extension and flexion
Key exclusion criteria
patients having contraindication for MRI scan
patients with multiple episodes of stroke
patients having difficulties to participate in the study due to cognitive impairment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriaki Hattori |
Organization
Morinomiya Hospital
Division name
Neurorehabilitation Research Institute
Zip code
Address
2-1-88, Morinomiya, Joto-ku, Osaka-shi, Osaka, Japan
TEL
06-6969-8170
hattori@omichikai.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Okuda |
Organization
Morinomiya Hospital
Division name
Neurorehabilitation Research Institute
Zip code
Address
2-1-88, Morinomiya, Joto-ku, Osaka-shi, Osaka, Japan
TEL
06-6969-0111
Homepage URL
okuda@omichikai.or.jp
Sponsor or person
Institute
Morinomiya Hospital
Institute
Department
Personal name
Funding Source
Organization
Morinomiya Hospital
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
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
| 2012 | Year | 11 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 16 | Day |
Last modified on
| 2013 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010975
