UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014336 |
|---|---|
| Receipt number | R000016680 |
| Scientific Title | The feasibility and safety study of the central nervous functional recovery therapy using a wearable human support robot HAL for the patients with the central motor dysfunction. |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2016/09/28 21:58:23 |
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Basic information
Public title
The feasibility and safety study of the central nervous functional recovery therapy using a wearable human support robot HAL for the patients with the central motor dysfunction.
Acronym
The feasibility and safety study of the functional recovery therapy using a robot suit HAL for the central motor dysfunction.
Scientific Title
The feasibility and safety study of the central nervous functional recovery therapy using a wearable human support robot HAL for the patients with the central motor dysfunction.
Scientific Title:Acronym
The feasibility and safety study of the functional recovery therapy using a robot suit HAL for the central motor dysfunction.
Region
| Japan |
Condition
Condition
The central moter dysfunction associated with stroke, cerebrospinal injury, cerebrospinal tumor and neuromusclar disease
Classification by specialty
| Neurology | Orthopedics | Neurosurgery |
| Emergency medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety and feasibility of clinical trials to evaluate the promotion of improvement in central motor dysfuction by performing the treatment of functional recovery using HAL in the acute phase.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Adverse event
2. Failure of HAL and ancillary equipment
3. Feasibility of study protocol
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
The treatment of functional recovery using HAL for single joint or HAL for lower limb, about 2 times for a week.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients can consent by a document. If the handwriting is difficult due to the primary disease, it is assumed to obtain a document consent from ghost-writing user.
2. Patients 16 years of age or older. The consent of the legal representative's is needed for the patients of minors 16-20 years of age.
3. Patients who are hospitalized in the general ward, ICU or HCU.
4. Patients can wear HAL, weighing 40-100 kg, height is 150-190 cm.
5. Patients who can be hospitalized continuously along the test schedule.
Key exclusion criteria
1. It is difficult to perform the volantary movement of the limbs in accordance with the instructions due to the disturbance of consciousness or dementia.
2. It is difficult to wear HAL or train using HAL due to the severe deformation of the skeletal system.
3. Patients has a complication, which can disturb the treatment using HAL.
4. The biological edectrode for HAL can not be affixed to patient's skin due to the skin disease.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Matsumura |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Division of Clinical Medicine, Department of Neurosurgery
Zip code
Address
1-1-1 Tennodai Tsukuba, Ibaraki Japan
TEL
029-853-3220
a-matsumur@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aiki Marushima |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Division of Clinical Medicine, Department of Neurosurgery, Emergency and Critical Care Medicine
Zip code
Address
1-1-1 Tennodai Tsukuba, Ibaraki Japan
TEL
029-853-3220
Homepage URL
aiki.marushima@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Other
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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 14 | 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 | 06 | Month | 21 | Day |
Last modified on
| 2016 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016680
