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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021405
Receipt No. 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

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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
Email 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
Email hirai@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024691

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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