UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021314
Receipt number R000024580
Scientific Title Effect of a human-type communication robot on the cognitive function of elderly people
Date of disclosure of the study information 2016/04/01
Last modified on 2020/03/06 14:37:10

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Basic information

Public title

Effect of a human-type communication robot on the cognitive function of elderly people

Acronym

A human-type communication robot and the cognitive function

Scientific Title

Effect of a human-type communication robot on the cognitive function of elderly people

Scientific Title:Acronym

A human-type communication robot and the cognitive function

Region

Japan


Condition

Condition

cognitive function

Classification by specialty

Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We examine the effects of a human-type communication robot on the cognitive function of elderly people living a nursing home. We observe them for 2 months.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

mental state examination score using the Mini-Mental State Examinaton (MMSE) test, 2 months after the intervention

Key secondary outcomes

judgement, and verbal memory function


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Communicating with the robot
2 months

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

70 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Good health was required for participation and was assessed by physical examination, blood chemistry panel, lipid profile and complete blood count.

Key exclusion criteria

Persons who reject to participate the program

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kanako Ikeya

Organization

The University of Tokyo

Division name

Department of Advanced Clinical Science and Therapeutics

Zip code


Address

7-3-1 Hongo, Bunkyo, Tokyo, Japan

TEL

81-3-5800-9116

Email

ikeya0330@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Kanako Ikeya

Organization

The University of Tokyo

Division name

Department of Advanced Clinical Science and Therapeutics

Zip code


Address

7-3-1 Hongo, Bunkyo, Tokyo, Japan

TEL

81-3-5800-9116

Homepage URL


Email

ikeya0330@gmail.com


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Mitsubishi Foundation, Health Science Center Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

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

2016 Year 04 Month 01 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 03 Month 03 Day

Date of IRB

2016 Year 03 Month 03 Day

Anticipated trial start date

2016 Year 04 Month 06 Day

Last follow-up date

2016 Year 04 Month 06 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 03 Month 03 Day

Last modified on

2020 Year 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024580


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name