UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012764 |
|---|---|
| Receipt number | R000014756 |
| Scientific Title | The efficacy of rehabilitation using Robot suit HAL against brain injury |
| Date of disclosure of the study information | 2014/01/06 |
| Last modified on | 2016/07/12 15:25:58 |
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Basic information
Public title
The efficacy of rehabilitation using Robot suit HAL against brain injury
Acronym
Rehabilitation using Robot suit HAL
Scientific Title
The efficacy of rehabilitation using Robot suit HAL against brain injury
Scientific Title:Acronym
Rehabilitation using Robot suit HAL
Region
| Japan |
Condition
Condition
Brain injury
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The quantitative analysis of the efficacy of HAL against brain injury.
The possibility of the rehabilitation using HAL against brain injury.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
1. balancing ability
2. gait ability
Key secondary outcomes
1.Functional. Independence. Measure
2.ADL
3.QOL
4.Profile of Mood States
etc.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Rehabilitation using HAL
4 weeks
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The patients with brain injury admitted in Kyoto University Hospital
2. Motor weakness in lower limb
3. Adult patients without cognitive functional impairment
4. Adult patients with agreement
5. The patients who can be suitable for HAL
6. The patients who can be received usual rehabilitationL
Key exclusion criteria
1. without uncontrolable circulation diseases
2. without uncontrolable pulmonary diseases
3. without cognitive function disorder
4. withour joint disorder
5. without involuntary movement, ataxia and abnormal reflexes
6. without joint contracture
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Miyamoto |
Organization
Kyoto University Graduate School of Medicine
Division name
Neurosurgery
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo, Kyoto
TEL
075-751-3653
miy@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Takagi |
Organization
Kyoto University Graduate School of Medicine
Division name
Neurosurgery
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo, Kyoto
TEL
075-751-3653
Homepage URL
ytakagi@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
A-STEP
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
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 06 | Day |
Last modified on
| 2016 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014756
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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