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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016833
Receipt No. R000019536
Scientific Title Analysis of functional change in brain, associated with rehabilitation using "HAL (Hybrid Assistive Limb)"
Date of disclosure of the study information 2015/03/18
Last modified on 2016/02/03

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Basic information
Public title Analysis of functional change in brain, associated with rehabilitation using "HAL (Hybrid Assistive Limb)"
Acronym Analysis of brain function associated with "HAL" rehabilitation
Scientific Title Analysis of functional change in brain, associated with rehabilitation using "HAL (Hybrid Assistive Limb)"
Scientific Title:Acronym Analysis of brain function associated with "HAL" rehabilitation
Region
Japan

Condition
Condition Any cases of brain damage
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to clarify the mechanism of brain dysfunction based on various disease, and to improve the effect of rehabilitation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes With anatomical and functional analyzing technique of MRI, we will estimate any change along with rehabilitation both anatomically and functionally.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Rehabilitation with "HAL"
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
16 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Any cases with brain damage, who have paralysis or paresis in lower extremities, can express the informed consent, big enough to fit "HAL", and can continue the conventional rehabilitation.
Key exclusion criteria Cases, who have uncontrollable cardiovascular or pulmonary disease, can not understand the purpose of this study, have any damage to joint, have severe involuntary movement or ataxia, have severe spasticity, and have any metal implantation contraindicate to MRI scan.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Miyamoto
Organization Kyoto University Graduate School of Medicine
Division name Neurosurgery
Zip code
Address 54 Shogoinkawahara-cho Sakyo-ku Kyoto
TEL 075-751-3459
Email kuny@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeharu Kunieda
Organization Kyoto University Graduate School of Medicine
Division name Neurosurgery
Zip code
Address 54 Shogoinkawahara-cho Sakyo-ku Kyoto
TEL +81-75-751-3459
Homepage URL
Email kuny@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Neurosurgery, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japanese Society for the Promotion of Science
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
2015 Year 03 Month 18 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 Preinitiation
Date of protocol fixation
2015 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 18 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
2015 Year 03 Month 18 Day
Last modified on
2016 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019536

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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