UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016833 |
|---|---|
| Receipt number | R000019536 |
| Scientific Title | Analysis of functional change in brain, associated with rehabilitation using "HAL (Hybrid Assistive Limb)" |
| Date of disclosure of the study information | 2015/03/18 |
| Last modified on | 2020/09/27 10:06:35 |
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Basic information
Public title
Analysis of functional change in brain, associated with rehabilitation using "HAL (Hybrid Assistive Limb)"
Acronym
Analysis of brain function associated with "HAL" rehabilitation
Scientific Title
Analysis of functional change in brain, associated with rehabilitation using "HAL (Hybrid Assistive Limb)"
Scientific Title:Acronym
Analysis of brain function associated with "HAL" rehabilitation
Region
| Japan |
Condition
Condition
Any cases of brain damage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to clarify the mechanism of brain dysfunction based on various disease, and to improve the effect of rehabilitation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
With anatomical and functional analyzing technique of MRI, we will estimate any change along with rehabilitation both anatomically and functionally.
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
Rehabilitation with "HAL"
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Any cases with brain damage, who have paralysis or paresis in lower extremities, can express the informed consent, big enough to fit "HAL", and can continue the conventional rehabilitation.
Key exclusion criteria
Cases, who have uncontrollable cardiovascular or pulmonary disease, can not understand the purpose of this study, have any damage to joint, have severe involuntary movement or ataxia, have severe spasticity, and have any metal implantation contraindicate to MRI scan.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Miyamoto |
Organization
Kyoto University Graduate School of Medicine
Division name
Neurosurgery
Zip code
606-8507
Address
54 Shogoinkawahara-cho Sakyo-ku Kyoto
TEL
075-751-3459
miy@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Kikuchi |
Organization
Kyoto University Graduate School of Medicine
Division name
Neurosurgery
Zip code
606-8507
Address
54 Shogoinkawahara-cho Sakyo-ku Kyoto
TEL
+81-75-751-3459
Homepage URL
tkik@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for the Promotion of Science
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
Kyoto University Graduate School of Medicine
Address
54 Shogoinkawahara-cho Sakyo-ku Kyoto
Tel
+81-75-751-3459
tkik@kuhp.kyoto-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 18 | Day |
Last modified on
| 2020 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019536
