UMIN-CTR Clinical Trial

Public title

Safety and feasibility study of walking motion support using mobile support robot

Acronym

Safety and feasibility study of mobile support robot

Scientific Title

Safety and feasibility study of walking motion support using mobile support robot

Scientific Title:Acronym

Safety and feasibility study of mobile support robot

Region

Japan

Condition

Patients with stroke, bone joint diseases, spinal cord diseases, infectious diseases such as pneumonia and so on.

Classification by specialty

Medicine in general	Gastroenterology	Hepato-biliary-pancreatic medicine
Cardiology	Pneumology	Neurology
Surgery in general	Orthopedics	Neurosurgery
Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the safety and feasibility of the mobile support robot for people with motor impairment.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Safety (status of occurrence of adverse event, situation of malfunction of this equipment)
Feasibility (completion rate of walking movement using this equipment)

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Move the setting circle course by walking using the mobile support robot.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who satisfy all the following criteria are targeted.
1. A patient who can consent to the document by himself/herself. If writing is difficult due to hemiplegia or the like, put a substitute writer.
2. A patient aged 20 years or older at consent acquisition.
3. A patient within 6 months after onset of disease.
4. A patient with normal walking rehabilitation and with functional walking scale (Functional Ambulation Category) 1 to 4.
5. A patient whose height is approximately within 140-180 cm and whose weight is approximately within 40-100 kg.

Key exclusion criteria

Patients who conflict with one of the following criteria are excluded and not subject to this clinical study.
1. A patient who is judged to have the following findings by the research director or the research assignee.
1) A patient with advanced immobility, contraction and ataxia.
2) A patient who is judged to be difficult to understand instructions (including patients who can not understand instructions and express their own condition due to aphasia).
3) A patient who have severe spasticity, deformation, contracture of the lower limbs and judgment that walking practice is difficult.
2. A patient who is judged inappropriate to participate in the study by the research director or research assignee.

Target sample size

10

Name of lead principal investigator

1st name	Akira
Middle name
Last name	Matsumura

Organization

Faculty of Medicine, University of Tsukuba

Division name

Division of Clinical Medicine, Department of Neurosurgery

Zip code

305-8575

Address

1-1-1 Tennodai, Tsukuba, Ibaraki Japan

TEL

029-853-3220

Email

a-matsumur@md.tsukuba.ac.jp

Name of contact person

1st name	Aiki
Middle name
Last name	Marushima

Organization

Faculty of Medicine, University of Tsukuba

Division name

Division of Clinical Medicine, Department of Neurosurgery, Emergency and Critical Care Medicine

Zip code

305-8575

Address

1-1-1 Tennodai Tsukuba, Ibaraki Japan

TEL

029-853-3220

Homepage URL

Email

aiki.marushima@md.tsukuba.ac.jp

Institute

University of Tsukuba

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

T-CReDO

Address

1-1-1 Tennodai, Tsukuba, Ibaraki Japan

Tel

029-853-3675

Email

watanabe.hiroki.gb@u.tsukuba.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

12

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2018

Year

11

Month

21

Day

Date of IRB

Anticipated trial start date

2018

Year

12

Month

18

Day

Last follow-up date

2019

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

12

Month

11

Day

Last modified on

2019

Year

12

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040134