UMIN-CTR Clinical Trial

Basic information
Public title	A study of safety and efficacy of HAL for hemiparesis due to the brain disease in the research project of [A study for efficacy of functional recovery therapy using the Robot Suit HAL for the motor function disorder due to the cerebrospinal diseases, and construction of regional cooperation program of HAL]
Acronym	A study of safety and efficacy of HAL for hemiparesis due to the brain disease
Scientific Title	A study of safety and efficacy of HAL for hemiparesis due to the brain disease in the research project of [A study for efficacy of functional recovery therapy using the Robot Suit HAL for the motor function disorder due to the cerebrospinal diseases, and construction of regional cooperation program of HAL]
Scientific Title:Acronym	A study of safety and efficacy of HAL for hemiparesis due to the brain disease
Region	Japan

Condition
Condition	Stroke (Cerebral infarction, Cerebral hemorrhage)
Classification by specialty	Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the safety and efficacy of using the HAL (HAL group) to compare the difference of recovery process about gait disorder, motor dysfunction and activities of daily living with conventional physiotherapy (Control group) in individuals brain disease with the hemiparesis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Functional Ambulation Category (FAC)
Key secondary outcomes	Brunnstrom stage (BRs) 12grade hemiplesia functional test NIHSS Fugl-meyer assessnment (FMA) 6m-Gait speed, Stride, Cadence, Gait-form Gait distance for 6 min modified Rankin Scale (mRS) Barthel Index (BI) motor Functional Independence Measure (motor FIM) MMSE Duration of hospitalization and research Frequency of HAL treatment and conventional physiotherapy Adverse event EMG TMS-MEP F wave, H wave EEG fMRI, resting-state fMRI, DTI Oxidatiove stress index Platelet aggregation

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	HAL group performed gait training using the HAL 3 times a week with a total of 9 HAL training sessions (3 weeks).
Interventions/Control_2	Conventional group performed conventional physical therapy 3 times a week with a total of 9 conventional physical therapy sessions (3 weeks).
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Hemiparesis resulting from unilateral ischemic or hemorrhagic stroke in the acute phase. 2)Age:40-80 years old 3)Time since stroke onset within 7-14 days. 4)Functional Ambulation Category (FAC) 1-2 5)Patient can ensure more than 3 weeks from intervention initiation. 6)Patient with a score of more than 4 on the FAC prior to stroke. 7)Patient can consent by a document. If the handwriting is difficult due to the paralysis, it is assumed to obtain a document consent from ghost-writing user. 8)Patient who can be suitable for HAL (only HAL group)
Key exclusion criteria	1)It is difficult to perform the voluntary movement of the limbs in accordance with the instructions due to the disturbance of consciousness. 2)Patients has a complication, for example, severe cardiac disease and musculoskeletal system which can disturb the treatment using HAL. 3)Patients who investigator or sub investigator deemed inappropriate In this clinical trial. 4)Patients received magnetic stimulation, electrical stimulation and so no, neuromodulation therapy prior to the this study.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Matsumura
Organization	Faculty of Medicine, University of Tsukuba
Division name	Department of Neurosurgery
Zip code	305-8575
Address	1-1-1 Tennodai, Tsukuba, Ibaraki Japan
TEL	029-853-3220
Email	a-matsumur@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Aiki Middle name Last name Marushima
Organization	Faculty of Medicine, University of Tsukuba
Division name	Department of Neurosurgery and Stroke
Zip code	305-8575
Address	1-1-1 Tennodai, Tsukuba, Ibaraki Japan
TEL	029-853-3220
Homepage URL
Email	aiki.marushima@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
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	T-CReDO
Address	1-1-1 Tennodai, Tsukuba, Ibaraki Japan
Tel	029-853-3220
Email	aiki.marushima@md.tsukuba.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	筑波大学附属病院 (茨城県)　(University of Tsukuba Hospital) 関連病院

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 23 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	2016 Year 09 Month 21 Day
Date of IRB	2016 Year 06 Month 30 Day
Anticipated trial start date	2016 Year 09 Month 21 Day
Last follow-up date	2019 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	2016 Year 05 Month 23 Day
Last modified on	2019 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025826