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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035893
Receipt No. R000040895
Scientific Title Observational study for expected sense of loss and mechanism of the treatment using self-supported robot for intractable neurological diseases
Date of disclosure of the study information 2019/03/31
Last modified on 2019/08/18

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Basic information
Public title Observational study for expected sense of loss and mechanism of the treatment using self-supported robot for intractable neurological diseases
Acronym Observational study of the self-supported robot for intractable neurological diseases
Scientific Title Observational study for expected sense of loss and mechanism of the treatment using self-supported robot for intractable neurological diseases
Scientific Title:Acronym Observational study of the self-supported robot 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 observe 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 for consecutive 5 days, and following 3 weeks after installing HAL
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 HA
Target sample size 6

Research contact person
Name of lead principal investigator
1st name MASAHIKO
Middle name
Last name TANIGUCHI
Organization St. Mary Hospital
Division name Department of Surgery
Zip code 8308543
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 MASAHIKO
Middle name
Last name TANIGUCHI
Organization St. Mary Hospital
Division name Department of Surgery
Zip code 8308543
Address Tsubukuhonmachi 422, Kurume, Fukuoka
TEL 0942-35-3322
Homepage URL
Email m-tani@st-mary-med.or.jp

Sponsor
Institute Department of Surgery
St. Mary Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labor 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 St. Mary Hospital
Address 422 Tsubukuhonmachi Kurume city
Tel 0942-35-3322
Email masako.inoue@st-mary-med.or.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 雪の聖母会 聖マリア病院(福岡県)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 31 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 6
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
2019 Year 02 Month 10 Day
Date of IRB
2019 Year 02 Month 10 Day
Anticipated trial start date
2019 Year 02 Month 11 Day
Last follow-up date
2019 Year 02 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information before observational study

Management information
Registered date
2019 Year 02 Month 16 Day
Last modified on
2019 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040895

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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