UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The feasibility and safety study of the central nervous functional recovery therapy using a wearable human support robot HAL for the patients with the central motor dysfunction.
Title of the study (Brief title)	The feasibility and safety study of the functional recovery therapy using a robot suit HAL for the central motor dysfunction.
Region	Japan

Condition
Condition	The central moter dysfunction associated with stroke, cerebrospinal injury, cerebrospinal tumor and neuromusclar disease
Classification by specialty	Neurology Orthopedics Neurosurgery Emergency medicine Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the safety and feasibility of clinical trials to evaluate the promotion of improvement in central motor dysfuction by performing the treatment of functional recovery using HAL in the acute phase.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Adverse event 2. Failure of HAL and ancillary equipment 3. Feasibility of study protocol
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	The treatment of functional recovery using HAL for single joint or HAL for lower limb, about 2 times for a week.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients can consent by a document. If the handwriting is difficult due to the primary disease, it is assumed to obtain a document consent from ghost-writing user. 2. Patients 16 years of age or older. The consent of the legal representative's is needed for the patients of minors 16-20 years of age. 3. Patients who are hospitalized in the general ward, ICU or HCU. 4. Patients can wear HAL, weighing 40-100 kg, height is 150-190 cm. 5. Patients who can be hospitalized continuously along the test schedule.
Key exclusion criteria	1. It is difficult to perform the volantary movement of the limbs in accordance with the instructions due to the disturbance of consciousness or dementia. 2. It is difficult to wear HAL or train using HAL due to the severe deformation of the skeletal system. 3. Patients has a complication, which can disturb the treatment using HAL. 4. The biological edectrode for HAL can not be affixed to patient's skin due to the skin disease.
Target sample size	15

Research contact person
Name of lead principal investigator	Akira Matsumura
Organization	Faculty of Medicine, University of Tsukuba
Division name	Division of Clinical Medicine, Department of Neurosurgery
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	Aiki Marushima
Organization	Faculty of Medicine, University of Tsukuba
Division name	Division of Clinical Medicine, Department of Neurosurgery, Emergency and Critical Care Medicine
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	University of Tsukuba
Organization
Division
Category of Funding Organization	Other
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	筑波大学附属病院（茨城県）

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 06 Month 23 Day
Anticipated trial start date	2014 Year 07 Month 14 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 06 Month 21 Day
Last modified on	2016 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016680