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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028489
Receipt No. 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

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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
Email 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
Email tanemura@mw.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki University of Medical Welfare
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032512

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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