UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of neuro-engineering treatment using HAL for intractable neurological diseases
Title of the study (Brief title)	The effectiveness of HAL for intractable neurological diseases
Region	Japan

Condition
Condition	intractable neurological diseases
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness and safety of HAL for the patients with intractable neurological diseases
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Simple test for evaluating hand function
Key secondary outcomes	Examination of muscle tonus

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	equip HAL for 3 days
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	intractable neurological diseases
Key exclusion criteria	active infectious disease systemic breakdown patient who cannot equip HAL
Target sample size	1

Research contact person
Name of lead principal investigator	MASAHIKO TANIGUCHI
Organization	St. Mary Hospital
Division name	Division of Transplant Surgery
Address	Tsubukuhonmachi 422, Kurume, Fukuoka
TEL	0942-35-3322
Email	m-tani@st-mary-med.or.jp

Public contact
Name of contact person	MASAHIKO TANIGUCHI
Organization	St. Mary Hospital
Division name	Division of Transplant Surgery
Address	Tsubukuhonmachi 422, Kurume, Fukuoka
TEL	0942-35-3322
Homepage URL
Email	m-tani@st-mary-med.or.jp

Sponsor
Institute	Division of Transplant Surgery St. Mary Hospital
Institute
Department

Funding Source
Organization	self-sustaining
Organization
Division
Category of Funding Organization	Self funding
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	雪の聖母会　聖マリア病院（福岡県）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 18 Day
Anticipated trial start date	2018 Year 03 Month 19 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 04 Month 30 Day
Date trial data considered complete	2018 Year 04 Month 30 Day
Date analysis concluded	2018 Year 04 Month 30 Day

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

Management information
Registered date	2018 Year 03 Month 20 Day
Last modified on	2018 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036321