UMIN-CTR Clinical Trial

Public title

The feasibility and safety study of the central nervous functional recovery therapy using a wearable human support robot HAL for the patients with the central motor dysfunction.

Acronym

The feasibility and safety study of the functional recovery therapy using a robot suit HAL for the central motor dysfunction.

Scientific Title

The feasibility and safety study of the central nervous functional recovery therapy using a wearable human support robot HAL for the patients with the central motor dysfunction.

Scientific Title:Acronym

The feasibility and safety study of the functional recovery therapy using a robot suit HAL for the central motor dysfunction.

Region

Japan

Condition

The central moter dysfunction associated with stroke, cerebrospinal injury, cerebrospinal tumor and neuromusclar disease

Classification by specialty

Neurology	Orthopedics	Neurosurgery
Emergency medicine	Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the safety and feasibility of clinical trials to evaluate the promotion of improvement in central motor dysfuction by performing the treatment of functional recovery using HAL in the acute phase.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1. Adverse event
2. Failure of HAL and ancillary equipment
3. Feasibility of study protocol

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

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

The treatment of functional recovery using HAL for single joint or HAL for lower limb, about 2 times for a week.

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

16

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients can consent by a document. If the handwriting is difficult due to the primary disease, it is assumed to obtain a document consent from ghost-writing user.
2. Patients 16 years of age or older. The consent of the legal representative's is needed for the patients of minors 16-20 years of age.
3. Patients who are hospitalized in the general ward, ICU or HCU.
4. Patients can wear HAL, weighing 40-100 kg, height is 150-190 cm.
5. Patients who can be hospitalized continuously along the test schedule.

Key exclusion criteria

1. It is difficult to perform the volantary movement of the limbs in accordance with the instructions due to the disturbance of consciousness or dementia.
2. It is difficult to wear HAL or train using HAL due to the severe deformation of the skeletal system.
3. Patients has a complication, which can disturb the treatment using HAL.
4. The biological edectrode for HAL can not be affixed to patient's skin due to the skin disease.

Target sample size

15

Name of lead principal investigator

1st name
Middle name
Last name	Akira Matsumura

Organization

Faculty of Medicine, University of Tsukuba

Division name

Division of Clinical Medicine, Department of Neurosurgery

Zip code

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
Middle name
Last name	Aiki Marushima

Organization

Faculty of Medicine, University of Tsukuba

Division name

Division of Clinical Medicine, Department of Neurosurgery, 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

Institute

University of Tsukuba

Institute

Department

Personal name

Organization

University of Tsukuba

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

筑波大学附属病院（茨城県）

Date of disclosure of the study information

2014

Year

07

Month

01

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

Enrolling by invitation

Date of protocol fixation

2014

Year

06

Month

23

Day

Date of IRB

Anticipated trial start date

2014

Year

07

Month

14

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

06

Month

21

Day

Last modified on

2016

Year

09

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016680