UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015396
Receipt number R000017908
Scientific Title Gait exercise with Hybrid Assistive Limb (HAL)
Date of disclosure of the study information 2014/10/09
Last modified on 2014/10/09 23:20:02

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Basic information

Public title

Gait exercise with Hybrid Assistive Limb (HAL)

Acronym

Gait exercise with HAL

Scientific Title

Gait exercise with Hybrid Assistive Limb (HAL)

Scientific Title:Acronym

Gait exercise with HAL

Region

Japan


Condition

Condition

Normal subject

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effects of gait exercise with HAL

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

10M walk test, video analysis, gait analysis

Key secondary outcomes



Base

Study type


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Hybrid Assistive Limb (HAL)

Interventions/Control_2

without HAL

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Normal subject

Key exclusion criteria

Severe complications

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shuji Matsumoto

Organization

Kagoshima University

Division name

Dept. of Rehabilitation

Zip code


Address

Kirishima City

TEL

0995-78-2538

Email

shushu@m.kufm.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shuji Matsumoto

Organization

Kagoshima University

Division name

Dept. of Rehabilitation

Zip code


Address

Kirishima City

TEL

0995-78-2538

Homepage URL


Email

shushu@m.kufm.kagoshima-u.ac.jp


Sponsor or person

Institute

Kagoshima University

Institute

Department

Personal name



Funding Source

Organization

N/A

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 09 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

2013 Year 07 Month 31 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 09 Day

Last modified on

2014 Year 10 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017908


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name