UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028540
Receipt number R000032666
Scientific Title Effect of the "noukatsu balancer" on the cognitive function and other functions for people with dementia
Date of disclosure of the study information 2018/04/01
Last modified on 2017/08/04 19:24:38

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Basic information

Public title

Effect of the "noukatsu balancer" on the cognitive function and other functions for people with dementia

Acronym

Effect of the "noukatsu balancer" for people with dementia

Scientific Title

Effect of the "noukatsu balancer" on the cognitive function and other functions for people with dementia

Scientific Title:Acronym

Effect of the "noukatsu balancer" for people with dementia

Region

Japan


Condition

Condition

Dementia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study examines the effects in the practice of the noukatsu balancer to the cognitive function and the emotions, and self-care of people with dementia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hasegawa's Dementia Scale for Revised(HDS-R)
(Before the intervention start, the 5th week of the intervention, After the end of intervention)

Key secondary outcomes

Trail Making Test-A, B(TMT-A, B)
The Cornell Scale for Depression in Dementia(CSDD)
Multidimensional Observation Scale for Elderly Subjects(MOSES)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Intervention period; Eight weeks
Intervention frequency; 2 times per week
Intervention time: It is about 20 minutes per one session.
The contents of intervention: Implement the noukatsu balancer at a rehabilitation room.

Interventions/Control_2

Intervention period; Eight weeks
The contents of intervention; The usual care

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

40 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

We target people of the dementia within use start 1 month of Health Care Facilities for the Elderly Requiring Long-term Care of Hyogo in Japan.

Key exclusion criteria

We will exclude from the object those who cannot implement the noukatsu balancer because of the body and mental symptoms.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kiyoshi Maeda

Organization

kobe Gakuin University

Division name

Faculty of Rehabilitation

Zip code


Address

518 Arise Ikawadani-cho, Nishi-ku, kobe, Japan

TEL

078-974-1551

Email

maedak@reha.kobegakuin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshimichi Nakamae

Organization

kobe Gakuin University

Division name

Faculty of Rehabilitation

Zip code


Address

518 Arise Ikawadani-cho, Nishi-ku, kobe, Japan

TEL

078-974-1551

Homepage URL


Email

nakamae@reha.kobegakuin.ac.jp


Sponsor or person

Institute

kobe Gakuin University

Institute

Department

Personal name



Funding Source

Organization

Life Science Institute, Inc (LSII)

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Total brain care, Inc

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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 04 Month 01 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

Preinitiation

Date of protocol fixation

2017 Year 05 Month 26 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date


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 04 Day

Last modified on

2017 Year 08 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032666


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name