UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034680
Receipt number 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 15:49:18

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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 or person

Institute

Nagoya City Rehabilitation Agency

Institute

Department

Personal name



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

Value
https://center6.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