UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000024691