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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024212
Receipt No. 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

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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
Email 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
Email aiki.marushima@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027882

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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