UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028587
Receipt number 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 2022/02/15 18:16:05

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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

60


Research contact person

Name of lead principal investigator

1st name Louis
Middle name
Last name Yuge

Organization

Graduate School of Biomeidical and Health Sciences, Hiroshima University

Division name

Division of Bio-Environmental Sciences

Zip code

734-8551

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 Kei
Middle name
Last name Nakagawa

Organization

Graduate School of Biomeidical and Health Sciences, Hiroshima University

Division name

Division of Bio-Environmental Sciences

Zip code

734-8551

Address

1-2-3 Kasumi, Hiroshima, Japan

TEL

082-257-5406

Homepage URL


Email

keinakag@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University

Institute

Department

Personal name



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

Hiroshima University Certified Review Board

Address

1-2-3 Kasumi, Minami-ku, Hiroshima,Hiroshima 734-8551,JAPAN

Tel

082-257-1551

Email

iryo-seisaku@office.hiroshima-u.ac.jp


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
西広島リハビリテーション病院


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

2024 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

2022 Year 02 Month 15 Day



Link to view the page

Value
https://center6.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