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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039522
Receipt No. R000045072
Scientific Title A study on the effect of using a communication robot
Date of disclosure of the study information 2020/02/18
Last modified on 2020/02/18

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Basic information
Public title A study on the effect of using a communication robot
Acronym Effect of a communication robot
Scientific Title A study on the effect of using a communication robot
Scientific Title:Acronym Effect of a communication robot
Region
Japan

Condition
Condition Patients using visit home rehabilitation
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study was verification of the effect of using a baby-type communication robot for the home visit rehabilitation patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes COPM
Key secondary outcomes Basic information: age, medical history, need of care
SDS
FIM
Question about robot items(Items related to effect of robots such as Motivation, Communication, Sitting-time, Sleeping-time and Social morality)
ZBI

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 In addition to regular visit home rehabilitation, using a communication robot for one month
Interventions/Control_2 In addition to regular visit home rehabilitation, using a communication robot for one month
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The selection criteria are the users who are undergoing the visit home rehabilitation
General condition is stable
Patients who obtained informed consent for participation in this study
Key exclusion criteria The exclusion criteria were patients with difficulty in communication, as well as patients with severe dementia, alone patients, and patients with infection
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Izumi
Middle name
Last name Kondo
Organization National Center for Geriatrics and Geriatrics and Gerontology
Division name Department of Rehabilitation Medicine
Zip code 474-8511
Address 7-430, Morioka-cho, Obu, Aichi, 474-8511, Japan
TEL 0562-46-2311
Email ik7710@ncgg.go.jp

Public contact
Name of contact person
1st name Izumi
Middle name
Last name Kondo
Organization National Center for Geriatrics and Geriatrics and Gerontology
Division name Department of Rehabilitation Medicine
Zip code 474-8511
Address 7-430, Morioka-cho, Obu,Aichi, 474-8511, Japan
TEL 0562-46-2311
Homepage URL
Email ik7710@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Geriatrics and Gerontology
Institute
Department

Funding Source
Organization National Center for Geriatrics and Geriatrics and Gerontology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Center for Geriatrics and Geriatrics and Gerontology
Address 7-430, Morioka-cho, Obu, Aichi, 474-8511, Japan
Tel 0562-46-2311
Email rehab@ncgg.go.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

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 18 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
2017 Year 10 Month 30 Day
Date of IRB
2017 Year 10 Month 30 Day
Anticipated trial start date
2017 Year 10 Month 30 Day
Last follow-up date
2022 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
2020 Year 02 Month 18 Day
Last modified on
2020 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045072

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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