UMIN-CTR Clinical Trial

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 Susumu Middle name Last name Miyamoto
Organization	Kyoto University Graduate School of Medicine
Division name	Neurosurgery
Zip code	606-8507
Address	54 Shogoinkawahara-cho Sakyo-ku Kyoto
TEL	075-751-3459
Email	miy@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Takayuki Middle name Last name Kikuchi
Organization	Kyoto University Graduate School of Medicine
Division name	Neurosurgery
Zip code	606-8507
Address	54 Shogoinkawahara-cho Sakyo-ku Kyoto
TEL	+81-75-751-3459
Homepage URL
Email	tkik@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	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University Graduate School of Medicine
Address	54 Shogoinkawahara-cho Sakyo-ku Kyoto
Tel	+81-75-751-3459
Email	tkik@kuhp.kyoto-u.ac.jp

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	Terminated
Date of protocol fixation	2015 Year 03 Month 18 Day
Date of IRB	2015 Year 04 Month 24 Day
Anticipated trial start date	2015 Year 03 Month 18 Day
Last follow-up date	2018 Year 03 Month 31 Day
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	2020 Year 09 Month 27 Day

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