UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024212 |
|---|---|
| Receipt number | R000027882 |
| Scientific Title | Enforcement of the regional alliances with the convalescent hospital for the hemiparesis-patients with the brain disease in "the effective study of the function recovery treatment using RobotSuit HAL for the central motor dysfunction due to the cerebrospinal injury and a construction of the regional alliances function recovery treatment program" |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2018/10/01 23:41:19 |
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Basic information
Public title
Enforcement of the regional alliances with the convalescent hospital for the hemiparesis-patients with the brain disease in "the effective study of the function recovery treatment using RobotSuit HAL for the central motor dysfunction due to the cerebrospinal injury and a construction of the regional alliances function recovery treatment program"
Acronym
Regional alliances of RobotSuit HAL treatment for patients with hemiparesis due to the brain disease
Scientific Title
Enforcement of the regional alliances with the convalescent hospital for the hemiparesis-patients with the brain disease in "the effective study of the function recovery treatment using RobotSuit HAL for the central motor dysfunction due to the cerebrospinal injury and a construction of the regional alliances function recovery treatment program"
Scientific Title:Acronym
Regional alliances of RobotSuit HAL treatment for patients with hemiparesis due to the brain disease
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurosurgery | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To make regional alliances function recovery treatment program using the HAL built by continuing treatment using the HAL in stroke patients after convalescent rehabilitation ward hospital transfer for an acute phase, and performing it.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse event
Feasibility
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
HAL treatment
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Hemiparesis resulting from unilateral ischemic or hemorrhagic stroke in the acute phase.
2)Age:20-80 years old
3)Time since stroke onset within 7-14 days.
4)Functional Ambulation Category (FAC) 1-2
5)Patient can ensure more than 6 weeks from intervention initiation.
6)Patient with a score of more than 4 on the FAC prior to stroke.
7)Patient can consent by a document. If the handwriting is difficult due to the paralysis, it is assumed to obtain a document consent from ghost-writing user.
8)Patient who can be suitable for HAL
Key exclusion criteria
1)It is difficult to perform the voluntary movement of the limbs in accordance with the instructions due to the disturbance of consciousness.
2)Patients has a complication, for example, severe cardiac disease and musculoskeletal system which can disturb the treatment using HAL.
3)Patients who investigator or sub investigator deemed inappropriate In this clinical trial.
4)Patients received magnetic stimulation, electrical stimulation and so no, neuromodulation therapy prior to the this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Yamazaki |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Orthopedic Surgery
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki Japan
TEL
029-853-3525
masashiy@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
Department of Neurosurgery, Department of 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
Ministry of Health, Labour 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
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
| 2016 | Year | 10 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 28 | Day |
Last modified on
| 2018 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027882
| 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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| Registered date | File name |
