UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039522 |
|---|---|
| Receipt number | 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 09:42:08 |
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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
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
ik7710@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Geriatrics and Gerontology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045072
