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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035826
Receipt No. R000040762
Scientific Title Investigation of the factors associated with the motor function of patients with dementia in psychiatric fields.
Date of disclosure of the study information 2019/03/01
Last modified on 2019/02/12

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Basic information
Public title Investigation of the factors associated with the motor function of patients with dementia in psychiatric fields.
Acronym Investigation of the motor function of patients with dementia.
Scientific Title Investigation of the factors associated with the motor function of patients with dementia in psychiatric fields.
Scientific Title:Acronym Investigation of the motor function of patients with dementia.
Region
Japan

Condition
Condition Those who have dementia or Cognitive impairments.
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clarifying the factors which affect on the motor function of the patients with Dementia.
Basic objectives2 Others
Basic objectives -Others Clarifying the factors which are correlated or associated with walking function and clinical assessment or clinical features.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Clarifying those factors below associated with walking parameters.
1. Dignosis
2. Cognitive function
3. Medication
4. Past History or comorbidity.
Key secondary outcomes Clarifying the factors associated with fall by following for 6 months.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Dementia patients
Patients with cognitive impairments who have been treated in Yokohama Maioka Hospital, who have the ability to walk, and whose BPSD are well controlled.
Normal elderly and patients with Parkinson's disease who admitted joining our study.
Key exclusion criteria Those who the research director judge inappropriate.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko Kase
Organization Sekiai-kai Yokohama Maioka Hospital
Division name Medical Office
Zip code
Address 3482 Maioka-Tyo, Totsuka-Ku, Yokohama-Shi, Kanagawa-Ken
TEL +81-45-822-2125
Email CZG01164@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuhei Chiba
Organization Sekiai-kai Yokohama Maioka Hospital
Division name Medical Office
Zip code
Address 3482 Maioka-Tyo, Totsuka-Ku, Yokohama-Shi, Kanagawa-Ken
TEL +81-45-822-2125
Homepage URL
Email suezan_2000@yahoo.co.jp

Sponsor
Institute Sekiai-kai Yokohama Maioka Hospital
Institute
Department

Funding Source
Organization Sekiai-kai Yokohama Maioka Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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
2019 Year 03 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
2019 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 03 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 Observational Study

Management information
Registered date
2019 Year 02 Month 09 Day
Last modified on
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040762

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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