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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031808
Receipt No. R000036321
Scientific Title The effectiveness of neuro-engineering treatment using HAL for intractable neurological diseases
Date of disclosure of the study information 2018/03/22
Last modified on 2018/09/19

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Basic information
Public title The effectiveness of neuro-engineering treatment using HAL for
intractable neurological diseases
Acronym The effectiveness of HAL for
intractable neurological diseases
Scientific Title The effectiveness of neuro-engineering treatment using HAL for
intractable neurological diseases
Scientific Title:Acronym 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
1st name
Middle name
Last name MASAHIKO TANIGUCHI
Organization St. Mary Hospital
Division name Division of Transplant Surgery
Zip code
Address Tsubukuhonmachi 422, Kurume, Fukuoka
TEL 0942-35-3322
Email m-tani@st-mary-med.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name MASAHIKO TANIGUCHI
Organization St. Mary Hospital
Division name Division of Transplant Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2018 Year 03 Month 18 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000036321

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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