UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031808 |
|---|---|
| Receipt number | 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 13:04:54 |
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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
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
m-tani@st-mary-med.or.jp
Sponsor or person
Institute
Division of Transplant Surgery
St. Mary Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036321
