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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027451
Receipt No. R000031375
Scientific Title The effect of rehabilitation on brain function and fracture risk in elderly with fractures.
Date of disclosure of the study information 2017/06/05
Last modified on 2017/05/22

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Basic information
Public title The effect of rehabilitation on brain function and fracture risk in elderly with fractures.
Acronym The effect of rehabilitation on brain function and fracture risk in elderly with fractures.
Scientific Title The effect of rehabilitation on brain function and fracture risk in elderly with fractures.
Scientific Title:Acronym The effect of rehabilitation on brain function and fracture risk in elderly with fractures.
Region
Japan

Condition
Condition fractures
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to prevent decrease in quality of life in elderly with fractures, we will consider whether combination use of OT in addition to PT is effective
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of changes in brain functions between hospitalization and discharge before departure, depending on the type of rehabilitation.
Key secondary outcomes Comparison of changes in blood pentosidine at hospitalization and before discharge from the type of rehabilitation.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Rehabilitation will be conducted 120 minutes a day (PT 60 minutes and OT 60 minutes) every day from the day after hospitalization to discharge to the study subject.
Interventions/Control_2 Rehabilitation for PT 120 minutes a day for each day from hospitalization day to hospitalization for the subjects.
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
65 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients scheduled for rehabilitation only for PT in regular practice.
2)Elderly people over 65 years old in spinal vertebral fractures due to falls.
3)Elderly people over 65 years old who have fractured proximal femur due to falls.
4)Patients requiring hospitalization for more than one month.
Key exclusion criteria 1)Patients who broke with strong external force.
2)Patients with severe complications other than fractures.
Target sample size 50

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

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Mitsubishi
Organization Tottori University Factory of Medicine School of Health Sciences
Division name Department of Biological Regulation
Zip code
Address 86 Nishi-cho,Yonago-shi,Tottori-ken
TEL 0859-38-6354
Homepage URL
Email macchanyann@yahoo.co.jp

Sponsor
Institute Tottori University Factory of Medicine School of Health Sciences
Institute
Department

Funding Source
Organization No
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
2017 Year 06 Month 05 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
2017 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 05 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
2017 Year 05 Month 22 Day
Last modified on
2017 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031375

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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