UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013511
Receipt number R000015786
Scientific Title Examination about the behavior analysis using the inertial measurement unit.
Date of disclosure of the study information 2014/03/25
Last modified on 2015/01/23 15:25:30

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Basic information

Public title

Examination about the behavior analysis using the inertial measurement unit.

Acronym

Examination about the behavior analysis using the inertial measurement unit.

Scientific Title

Examination about the behavior analysis using the inertial measurement unit.

Scientific Title:Acronym

Examination about the behavior analysis using the inertial measurement unit.

Region

Japan


Condition

Condition

The patient whom ability to move is limited

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

establish a system inspecting a rehabilitation effect

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Agreement rate of true movement and the judgment result

Key secondary outcomes

amount of activity


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

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

puts on the unit and works

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

60 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1) ambulatory patient in Saku central hospital.
2) cerebrovascular. obstacle of the exercise function. disuse syndrome
3) The patient whom ability to move is limited.
4) J and A rank in the degree of independent living
5)stable disease
6)There is not a feeling of resistance for a device.
7)An agreement is provided

Key exclusion criteria

1) A device is buried in the body
2) metallic allergy
3)a desperately ill patient
4) Patient with the danger to be upset
5) Patient who has difficulty in wearing of the unit.
6) Inappropriate patient

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Fujii

Organization

Saku central hospital

Division name

Dep of rehabilitation

Zip code


Address

197 Usuda,Saku,Nagano

TEL

0267-82-3131

Email

Hiro-fj@hh.iij4u.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryuji Hokari

Organization

Seiko epson corporation

Division name

Corporate research & development Div

Zip code


Address

281 Fujimi,Fujimi-machi,Suwa-gun,Nagano

TEL

0266-61-0669

Homepage URL


Email

hokari.ryuji@exc.epson.co.jp


Sponsor or person

Institute

Seiko epson corporation

Institute

Department

Personal name



Funding Source

Organization

Seiko epson corporation

Organization

Division

Category of Funding Organization

Profit organization

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

佐久総合病院(長野県)


Other administrative information

Date of disclosure of the study information

2014 Year 03 Month 25 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

2014 Year 02 Month 06 Day

Date of IRB


Anticipated trial start date

2014 Year 04 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 03 Month 25 Day

Last modified on

2015 Year 01 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015786


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name