UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016406 |
|---|---|
| Receipt number | 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 09:19:33 |
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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
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
kurakami@med.tottori-u.ac.jp
Sponsor or person
Institute
Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019054
