UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028489 |
|---|---|
| Receipt number | R000032512 |
| Scientific Title | Develpoment of cognitive rehabilitation device with application software |
| Date of disclosure of the study information | 2018/03/31 |
| Last modified on | 2019/08/05 14:18:07 |
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Basic information
Public title
Develpoment of cognitive rehabilitation device with application software
Acronym
Develpoment of cognitive rehabilitation device
Scientific Title
Develpoment of cognitive rehabilitation device with application software
Scientific Title:Acronym
Develpoment of cognitive rehabilitation device
Region
| Japan |
Condition
Condition
Cerebrovascular disease
traumatic brain injury
neurocognitive disorders
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the usefulness of cognitive rehabilitation device with application to higher brain dysfunction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
scores of tasks in the cognitive rehabilitation device and neuropsychological tests
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
9
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Amount of intervention: 30 minutes, 5 times a week
times of intervention: 20 times
frequency: 1 time a day
Interventions/Control_2
Amount of intervention: 30 minutes, 5 times a week
times of intervention: 20 times
frequency: 1 time a day
Interventions/Control_3
Amount of intervention: 30 minutes, 5 times a week
times of intervention: 20 times
frequency: 1 time a day
Interventions/Control_4
Amount of intervention: 30 minutes, 5 times a week
times of intervention: 20 times
frequency: 1 time a day
Interventions/Control_5
Amount of intervention: 30 minutes, 5 times a week
times of intervention: 20 times
frequency: 1 time a day
Interventions/Control_6
Amount of intervention: 30 minutes, 5 times a week
times of intervention: 20 times
frequency: 1 time a day
Interventions/Control_7
Amount of intervention: 30 minutes, 5 times a week
times of intervention: 20 times
frequency: 1 time a day
Interventions/Control_8
Amount of intervention: 30 minutes, 5 times a week
times of intervention: 20 times
frequency: 1 time a day
Interventions/Control_9
Amount of intervention: 30 minutes, 5 times a week
times of intervention: 20 times
frequency: 1 time a day
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects with proper comprehension of the tasks in the cognitive rehabilitation device, cognitive skills and physical skills
Key exclusion criteria
Subjects without proper comprehension of the tasks , cognitive skills nor physical skills
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | tanemura |
Organization
Kawasaki University of Medical Welfare
Division name
Sensory Science
Zip code
7010193
Address
288, Matsushima, Kurashiki-shi, Okayama
TEL
086-462-1111
tanemura@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Tanemura |
Organization
Kawasaki University of Medical Welfare
Division name
Sensory Science
Zip code
7010193
Address
288, Matsushima, Kurashiki-shi, Okayama
TEL
086-462-1111
Homepage URL
tanemura@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki University of Medical Welfare
Institute
Department
Personal name
Funding Source
Organization
none
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
Kawasaki University of Medical Welfare
Address
288, Matsushima, Kurashiki-shi, Okayama
Tel
086-462-1111
tanemura@mw.kawasaki-m.ac.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
| 2018 | Year | 03 | Month | 31 | 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
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 02 | Day |
Last modified on
| 2019 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032512
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
