UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021405 |
|---|---|
| Receipt number | R000024691 |
| Scientific Title | Non-invasive assessment of the effects of rehabilitation in stroke patients by measuring both behavioral and neural responses |
| Date of disclosure of the study information | 2016/03/09 |
| Last modified on | 2019/09/14 18:11:22 |
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Basic information
Public title
Non-invasive assessment of the effects of rehabilitation in stroke patients by measuring both behavioral and neural responses
Acronym
Non-invasive assessment of the effects of rehabilitation in stroke patients by measuring both behavioral and neural responses
Scientific Title
Non-invasive assessment of the effects of rehabilitation in stroke patients by measuring both behavioral and neural responses
Scientific Title:Acronym
Non-invasive assessment of the effects of rehabilitation in stroke patients by measuring both behavioral and neural responses
Region
| Japan |
Condition
Condition
Hemiplegic stroke patients
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The goal of the study is to explore the individual differences of motor performance and brain activity during post stroke acute rehabilitation period. The effects of these outcomes on the functional recovery will be evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MRI image (T1, T2, DTI), fMRI image, OxyHb and DeoxyHb measured by NIRS, behavioral data measured by motion capture system, functional assessments (Fugl-Meyer assessment, BIT, MMSE)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Repeated arm movements on the affected side
The frequency of intervention: once per week, (up to 1 month at maximum).
100 trials per intervention
Time for evaluation:Before intervention and one month after the intervention
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Paresis of the tested upper limb
2. No communication difficulty
Key exclusion criteria
1. Severe sensory loss of the upper limb
2. MMSE score less than 24
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Hirai |
Organization
Jichi Medical University
Division name
Functional Brain Science Laboratory, Center for Development of Advanced Medical Technology
Zip code
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7590
hirai@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Hirai |
Organization
Jichi Medical University
Division name
Functional Brain Science Laboratory, Center for Development of Advanced Medical Technology
Zip code
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7590
Homepage URL
hirai@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
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
| 2016 | Year | 03 | Month | 09 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 09 | Day |
Last modified on
| 2019 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024691
