UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The evaluation of the cognitive function in patients with fracture and the effect of rehabilitation on cerebral function
Title of the study (Brief title)	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	Katsuya Urakami
Organization	School of Health Science, Faculty of Medicine, Tottori University
Division name	Department of Biological Regulation
Address	86 Nishicho, Yonago, Tottori, Japan
TEL	0859-38-6354
Email	kurakami@med.tottori-u.ac.jp

Public contact
Name of contact person	Katsuya Urakami
Organization	School of Health Science, Faculty of Medicine, Tottori University
Division name	Department of Biological Regulation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019054