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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034680
Receipt No. R000037118
Scientific Title Reliability and validity of performance task by Universal Keyboard Unit and the relation to cognitive functions.
Date of disclosure of the study information 2018/10/29
Last modified on 2019/05/20

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Basic information
Public title Reliability and validity of performance task by Universal Keyboard Unit and the relation to cognitive functions.
Acronym Reliability and validity of performance task by Universal Keyboard Unit and the relation to cognitive functions.
Scientific Title Reliability and validity of performance task by Universal Keyboard Unit and the relation to cognitive functions.
Scientific Title:Acronym Reliability and validity of performance task by Universal Keyboard Unit and the relation to cognitive functions.
Region
Japan

Condition
Condition cognitive dysfunction
Classification by specialty
Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. To investigate the Reference value of healthy people in performance task by Universal Keyboard Unit (Universal Keyboard Unit:UKU).
2. To compare the results of performance task by UKU between healthy people and people with cognitive dysfunction.
3. To clarify the relationship between performance task by UKU and neuropsychological tests.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The number of pads achieved in performance task by UKU.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Healthy people and people with cognitive dysfunction undertake performance tasks by UKU and psychological tests.
Interventions/Control_2 Healthy people has performance task by UKU twice at intervals of one week.
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1. People with cognitive dysfunction
The doctor diagnosed cognitive dysfunction.
Subjects can hear the sound of UKU.
The subjects has not had motor paralysis in upper limbs.
The subjects has no visual field disturbance and aphasia.
The subjects knows "Twinkle, Twinkle, Little Star" of nursery rhymes.

2. Healthy people
Mini Mental State of examination(Mini Mental State of examination: MMSE) >= 28
Subjects can hear the sound of UKU.
The subjects has not had motor paralysis in upper limbs.
The subjects has no visual field disturbance and aphasia.
The subjects knows "Twinkle, Twinkle, Little Star" of nursery rhymes.
Key exclusion criteria The subjects could't hear the sound of UKU.
The subjects have motor paralysis in upper limbs.
The subjects have visual field disturbance and aphasia.
The subjects don't knows "Twinkle, Twinkle, Little Star" of nursery rhymes.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Ryuji
Middle name
Last name Ito
Organization Nagoya City Rehabilitation Agency
Division name Division of Occupational Therapy
Zip code 4678622
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL 052-835-3811
Email ot-dep@nagoya-rehab.or.jp

Public contact
Name of contact person
1st name Ryuji
Middle name
Last name Ito
Organization Nagoya City Rehabilitation Agency
Division name Division of Occupational Therapy
Zip code 4678622
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL 052-835-3811
Homepage URL
Email ot-dep@nagoya-rehab.or.jp

Sponsor
Institute Nagoya City Rehabilitation Agency
Institute
Department

Funding Source
Organization Nagoya City Rehabilitation Agency
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Nagoya City Rehabilitation Agency
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
Tel 052-835-3811
Email soumubu@nagoya-rehab.or.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 名古屋市総合リハビリテーション事業団(愛知県)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 29 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 45
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
2018 Year 05 Month 14 Day
Date of IRB
2018 Year 06 Month 15 Day
Anticipated trial start date
2018 Year 06 Month 15 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 10 Month 29 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037118

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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