UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006455
Receipt number R000007661
Scientific Title Multi-institutional intervention study of functional recovery for disabled persons using Hybrid Assistive Limb
Date of disclosure of the study information 2011/10/03
Last modified on 2018/10/09 12:04:08

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Basic information

Public title

Multi-institutional intervention study of functional recovery for disabled persons using Hybrid Assistive Limb

Acronym

Intervention of functional recovery for disabled persons using Hybrid Assistive Limb

Scientific Title

Multi-institutional intervention study of functional recovery for disabled persons using Hybrid Assistive Limb

Scientific Title:Acronym

Intervention of functional recovery for disabled persons using Hybrid Assistive Limb

Region

Japan


Condition

Condition

Cerebral stroke or other diseases

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and problem about physical function and Active Daily Living for disabled persons using Hybrid Assistive Limb

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Functional independence Measure (FIM)
Walking velocity of 10 m
continuous gait distance

Key secondary outcomes

Brunnstrome Stage (BRS)
Stroke Impairment Assessment Set (SIAS)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Patients by stroke or other disease who is in the recovery rehabilitation ward

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



Eligibility

Age-lower limit

15 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with stroke or other diseases who is in the recovery rehabilitation ward : above 15 years old

Key exclusion criteria

1.Lesion of cerebellum or brain stem
2.Subarachnoid hemorrhage
3.Severe cognitive dysfunction
4.Severe cardiorespiratory dysfunction
5.Severe osteoporosis
6.Body weight above 80kg
7.Pregnant woman
8. user of the active implantable medical devise

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sosuke Seki

Organization

Kawasaki Medical School

Division name

Department of rehabilitation medicine

Zip code


Address

577 Matsushima, Kurashiki city, Okayama prefecture, 701-0192 Japan

TEL

086-462-1111

Email

sseki@med.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Kousaka

Organization

Okayama Prefectural Government

Division name

Department of health and welfare

Zip code


Address

2-4-6 Uchisange, Okayama, 700-8570 Japan

TEL

086-226-7084

Homepage URL


Email

satoshi_kousaka1@pref.okayama.lg.jp


Sponsor or person

Institute

Kawasaki Medical School
Okayama Prefectural Government,Department of health and welfare

Institute

Department

Personal name



Funding Source

Organization

Okayama Prefectural Government

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan


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

川崎医科大学附属病院(岡山県)、岡村一心堂病院(岡山県)、岡山光南病院(岡山県)、北川病院(岡山県)、しげい病院(岡山県)、倉敷平成病院(岡山県)、倉敷紀念病院(岡山県)、渡辺病院(岡山県)、介護老人保健施設いるかの家リハビリテーションセンター(岡山県)、筑波大学大学院システム情報工学研究科(茨城県)


Other administrative information

Date of disclosure of the study information

2011 Year 10 Month 03 Day


Related information

URL releasing protocol


Publication of results

Published


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

2011 Year 07 Month 15 Day

Date of IRB


Anticipated trial start date

2011 Year 08 Month 01 Day

Last follow-up date

2014 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2014 Year 03 Month 25 Day


Other

Other related information



Management information

Registered date

2011 Year 10 Month 03 Day

Last modified on

2018 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=R000007661


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name