UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025352 |
|---|---|
| Receipt number | R000029180 |
| Scientific Title | A development of easy-to-use communication support device for users and carers |
| Date of disclosure of the study information | 2016/12/21 |
| Last modified on | 2018/11/06 14:17:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A development of easy-to-use communication support device for users and carers
Acronym
A development of easy-to-use communication support device for users and carers
Scientific Title
A development of easy-to-use communication support device for users and carers
Scientific Title:Acronym
A development of easy-to-use communication support device for users and carers
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the research is compared with the operability of the prototype communication control device and the operability of the conventional device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Operation process
Key secondary outcomes
Operation time
Ease of operation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Operation of prototype model 1 time 10 min.
Period 1 day
Interventions/Control_2
Control; Operation of conventional model 1 time 10 min.
Period 1 day
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adult
Key exclusion criteria
Cognitive disorders
Movement disorders
Sensory disorder
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoya Miyasaka |
Organization
Hokkaido University of Science
Division name
Dept. of Physical Therapy Faculty of Health Sciences
Zip code
Address
7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN
TEL
011-688-2232
tmiyasaka-hus@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoya Miyasaka |
Organization
Hokkaido University of Science
Division name
Dept. of Physical Therapy Faculty of Health Sciences
Zip code
Address
7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN
TEL
011-688-2232
Homepage URL
tmiyasaka-hus@umin.ac.jp
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 12 | Month | 21 | 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
| 2016 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 21 | Day |
Last modified on
| 2018 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029180
