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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016406
Receipt No. R000019054
Scientific Title The evaluation of the cognitive function in patients with fracture and the effect of rehabilitation on cerebral function
Date of disclosure of the study information 2015/02/03
Last modified on 2016/08/03

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Basic information
Public title The evaluation of the cognitive function in patients with fracture and the effect of rehabilitation on cerebral function
Acronym The evaluation of the cognitive function in patients with fracture and the effect of rehabilitation on cerebral function
Scientific Title The evaluation of the cognitive function in patients with fracture and the effect of rehabilitation on cerebral function
Scientific Title:Acronym The evaluation of the cognitive function in patients with fracture and the effect of rehabilitation on cerebral function
Region
Japan

Condition
Condition Femoral fracture, Spinal compression fracture
Classification by specialty
Neurology Geriatrics Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to investigate the relation between osteoporosis and cognitive function, and to evaluate the effect of rehabilitation on cerebral function. Eventually, we will evaluate changes in cognitive function of the hospitalized patients for fractures treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes electroencephalogram by Diagnosis Method of Neuronal Dysfunction(DIMENSION), Touch Panel-type Dementia Assessment Scale(TDAS), Blood test(Intact P1NP, TRACP-5b)
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 The electroencephalography for 5 to 15 minutes, Touch Panel-type Dementia Assessment Scale(TDAS), Blood test
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 (1)Femoral fracture
(2)Spinal compression fracture
Key exclusion criteria Patients other than the above
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuya Urakami
Organization School of Health Science, Faculty of Medicine, Tottori University
Division name Department of Biological Regulation
Zip code
Address 86 Nishicho, Yonago, Tottori, Japan
TEL 0859-38-6354
Email kurakami@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuya Urakami
Organization School of Health Science, Faculty of Medicine, Tottori University
Division name Department of Biological Regulation
Zip code
Address 86 Nishicho, Yonago, Tottori, Japan
TEL 0859-38-6354
Homepage URL
Email kurakami@med.tottori-u.ac.jp

Sponsor
Institute Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2015 Year 02 Month 03 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 Completed
Date of protocol fixation
2015 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 14 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
2015 Year 02 Month 01 Day
Last modified on
2016 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019054

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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