UMIN-CTR Clinical Trial

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 Akihiko Middle name Last name Kase
Organization	Sekiai-kai Yokohama Maioka Hospital
Division name	Medical Office
Zip code	244-0813
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 Chiba Middle name Last name Yuhei
Organization	Sekiai-kai Yokohama Maioka Hospital
Division name	Medical Office
Zip code	244-0813
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	Yokohama Maioka Hospital Review Board
Address	3482 Maioka-Tyo, Totsuka-Ku, Yokohama-Shi, Kanagawa-Ken
Tel	+81-45-822-2125
Email	none

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	Enrolling by invitation
Date of protocol fixation	2019 Year 03 Month 01 Day
Date of IRB	2019 Year 02 Month 06 Day
Anticipated trial start date	2019 Year 03 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
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	2020 Year 02 Month 11 Day

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