UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022410
Receipt number R000025826
Scientific Title A study of safety and efficacy of HAL for hemiparesis due to the brain disease in the research project of [A study for efficacy of functional recovery therapy using the Robot Suit HAL for the motor function disorder due to the cerebrospinal diseases, and construction of regional cooperation program of HAL]
Date of disclosure of the study information 2016/05/23
Last modified on 2019/11/25 18:00:44

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Basic information

Public title

A study of safety and efficacy of HAL for hemiparesis due to the brain disease in the research project of [A study for efficacy of functional recovery therapy using the Robot Suit HAL for the motor function disorder due to the cerebrospinal diseases, and construction of regional cooperation program of HAL]

Acronym

A study of safety and efficacy of HAL for hemiparesis due to the brain disease

Scientific Title

A study of safety and efficacy of HAL for hemiparesis due to the brain disease in the research project of [A study for efficacy of functional recovery therapy using the Robot Suit HAL for the motor function disorder due to the cerebrospinal diseases, and construction of regional cooperation program of HAL]

Scientific Title:Acronym

A study of safety and efficacy of HAL for hemiparesis due to the brain disease

Region

Japan


Condition

Condition

Stroke (Cerebral infarction, Cerebral hemorrhage)

Classification by specialty

Neurology Neurosurgery Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the safety and efficacy of using the HAL (HAL group) to compare the difference of recovery process about gait disorder, motor dysfunction and activities of daily living with conventional physiotherapy (Control group) in individuals brain disease with the hemiparesis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II


Assessment

Primary outcomes

Functional Ambulation Category (FAC)

Key secondary outcomes

Brunnstrom stage (BRs)
12grade hemiplesia functional test
NIHSS
Fugl-meyer assessnment (FMA)
6m-Gait speed, Stride, Cadence, Gait-form
Gait distance for 6 min

modified Rankin Scale (mRS)
Barthel Index (BI)
motor Functional Independence Measure (motor FIM)

MMSE

Duration of hospitalization and research
Frequency of HAL treatment and conventional physiotherapy

Adverse event

EMG
TMS-MEP
F wave, H wave
EEG

fMRI, resting-state fMRI, DTI

Oxidatiove stress index
Platelet aggregation


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


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

HAL group performed gait training using the HAL 3 times a week with a total of 9 HAL training sessions (3 weeks).

Interventions/Control_2

Conventional group performed conventional physical therapy 3 times a week with a total of 9 conventional physical therapy sessions (3 weeks).

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Hemiparesis resulting from unilateral ischemic or hemorrhagic stroke in the acute phase.
2)Age:40-80 years old
3)Time since stroke onset within 7-14 days.
4)Functional Ambulation Category (FAC) 1-2
5)Patient can ensure more than 3 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 (only HAL group)

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

50


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Matsumura

Organization

Faculty of Medicine, University of Tsukuba

Division name

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


Public contact

Name of contact person

1st name Aiki
Middle name
Last name Marushima

Organization

Faculty of Medicine, University of Tsukuba

Division name

Department of Neurosurgery and Stroke

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


Sponsor or person

Institute

University of Tsukuba

Institute

Department

Personal name



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

T-CReDO

Address

1-1-1 Tennodai, Tsukuba, Ibaraki Japan

Tel

029-853-3220

Email

aiki.marushima@md.tsukuba.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

筑波大学附属病院 (茨城県) (University of Tsukuba Hospital)
関連病院


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 23 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 09 Month 21 Day

Date of IRB

2016 Year 06 Month 30 Day

Anticipated trial start date

2016 Year 09 Month 21 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

Other related information



Management information

Registered date

2016 Year 05 Month 23 Day

Last modified on

2019 Year 11 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025826


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name