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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028587
Receipt No. R000032717
Scientific Title The effects of using a walking assistant robot "RE-Gait"
Date of disclosure of the study information 2017/08/08
Last modified on 2019/08/19

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Basic information
Public title The effects of using a walking assistant robot "RE-Gait"
Acronym The effects of a walking assistant robot "RE-Gait"
Scientific Title The effects of using a walking assistant robot "RE-Gait"
Scientific Title:Acronym The effects of a walking assistant robot "RE-Gait"
Region
Japan

Condition
Condition Cerebrovascular disease
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the effect of using a walking assist robot "RE-Gait" for the hemiplegic patients after stroke.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Joint angle of walking (hip, knee, foot)
Key secondary outcomes Walking speed, Stride length

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Walking exercise with the walking assistant robot "RE-Gait" (1month, 3 x 20 minutes per weak).
Interventions/Control_2 Walking exercise without the walking assistant robot (1month, 3 x 20 minutes per weak).
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. Persons with motor paralysis in one side limbs.
2. Persons who are considered to have a small risk of recurrence of the stroke (one or more months have passed since the onset of stroke).
3. Persons who do not have respiratory or cardiovascular disease
4. Persons with mild paralysis of lower limbs (Brunnstrom's recovery stage IV or higher).
5. Persons who can walk continuously for about 1 km at the monitoring level (canes and walking aids can be used).
6. Persons who do not allow limitation of the range of motion of the ankle joint.
7. Persons who can participate in walking practice (three times a week, one month).
8. Persons aged 20 to 80 at the time of consent.
9. Person who obtains consent in writing on participation of this study.
Key exclusion criteria 1. Persons with severe paralysis of lower limbs (Brunnstrom's recovery stage III or less).
2. Persons who have serious diseases other than the relevant diseases or diseases to be indicated for surgery.
3. Person who was judged to be difficult to participate in research from his / her own physician.
4. Women who are lactating, pregnant or may become pregnant.
5. Others who judged inappropriate by the research staffs.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Louis Yuge
Organization Graduate School of Biomeidical and Health Sciences, Hiroshima University
Division name Division of Bio-Environmental Sciences
Zip code
Address 1-2-3 Kasumi, Hiroshima, Japan
TEL 082-257-5425
Email ryuge@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Nakagawa
Organization Graduate School of Biomeidical and Health Sciences, Hiroshima University
Division name Division of Bio-Environmental Sciences
Zip code
Address 1-2-3 Kasumi, Hiroshima, Japan
TEL 082-257-5406
Homepage URL
Email keinakag@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Space Bio-Laboratories Co.,Ltd.
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 広島大学
県立広島病院
因島医師会病院

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 08 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 08 Day
Date of IRB
2019 Year 02 Month 13 Day
Anticipated trial start date
2017 Year 08 Month 08 Day
Last follow-up date
2022 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
2017 Year 08 Month 08 Day
Last modified on
2019 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032717

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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