UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of rehabilitation using Robot suit HAL against brain injury
Title of the study (Brief title)	Rehabilitation using Robot suit HAL
Region	Japan

Condition
Condition	Brain injury
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The quantitative analysis of the efficacy of HAL against brain injury. The possibility of the rehabilitation using HAL against brain injury.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	1. balancing ability 2. gait ability
Key secondary outcomes	1.Functional. Independence. Measure 2.ADL 3.QOL 4.Profile of Mood States etc.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Rehabilitation using HAL 4 weeks
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. The patients with brain injury admitted in Kyoto University Hospital 2. Motor weakness in lower limb 3. Adult patients without cognitive functional impairment 4. Adult patients with agreement 5. The patients who can be suitable for HAL 6. The patients who can be received usual rehabilitationL
Key exclusion criteria	1. without uncontrolable circulation diseases 2. without uncontrolable pulmonary diseases 3. without cognitive function disorder 4. withour joint disorder 5. without involuntary movement, ataxia and abnormal reflexes 6. without joint contracture
Target sample size	50

Research contact person
Name of lead principal investigator	Susumu Miyamoto
Organization	Kyoto University Graduate School of Medicine
Division name	Neurosurgery
Address	54 Kawahara-cho, Shogoin, Sakyo, Kyoto
TEL	075-751-3653
Email	miy@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Yasushi Takagi
Organization	Kyoto University Graduate School of Medicine
Division name	Neurosurgery
Address	54 Kawahara-cho, Shogoin, Sakyo, Kyoto
TEL	075-751-3653
Homepage URL
Email	ytakagi@kuhp.kyoto-u.ac.jp

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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	A-STEP
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	2014 Year 01 Month 06 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 01 Month 06 Day
Anticipated trial start date	2014 Year 01 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 01 Month 06 Day
Last modified on	2016 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014756