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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037175
Receipt No. R000041632
Scientific Title Attempt to improve motor image ability for older people who fall
Date of disclosure of the study information 2020/05/01
Last modified on 2019/06/25

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Basic information
Public title Attempt to improve motor image ability for older people who fall
Acronym Attempt to improve motor image ability for older people who fall
Scientific Title Attempt to improve motor image ability for older people who fall
Scientific Title:Acronym Attempt to improve motor image ability for older people who fall
Region
Japan

Condition
Condition Fracture patients due to falls
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 With regard to fall risk, risk factors have been elucidated from various perspectives.
Moreover, although exercise therapy is proposed as the correspondence, the report of the treatment effect for exercise image ability decline is not consistent.
We aim to contribute to the development of fall prevention by interventing and examining the effect on motor image ability decline.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes functional balance scale
imaged functional reach test
mental rotation test
kinesthetic and visual imagery qestionnaire
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Closed eye movement
Interventions/Control_2 open eye movement
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 Elderly people over 65
Person who is injured by hospital fall and is hospitalized
Key exclusion criteria Person who does not have pain regardless of resting / working time
Person without dementia
Person without neurological symptoms such as sensory disorders and numbness
Person without visual impairment
Person who does not show severe dizziness at present
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yoshiyuki
Middle name
Last name Sakoda
Organization Motoyama Rehabilitation Hospital
Division name rehabilitation
Zip code 6580015
Address 7-7-15 motoyamaminami-cho,hidgashinada-ku kobe-shi hyogo-ken
TEL 0784128080
Email sako19920707@gmail.com

Public contact
Name of contact person
1st name Yoshiyuki
Middle name
Last name Sakoda
Organization Motoyama Rehabilitation Hospital
Division name rehabilitation
Zip code 6580015
Address 7-7-15 motoyamaminami-cho,hidgashinada-ku kobe-shi hyogo-ken
TEL 0784128080
Homepage URL
Email sako19920707@gmail.com

Sponsor
Institute Motoyama Rehabilitation Hospital
Institute
Department

Funding Source
Organization Motoyama Rehabilitation Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Motoyama Rehabilitation Hospital
Address 7-7-15 motoyamaminami-cho,hidgashinada-ku kobe-shi hyogo-ken
Tel 0784128080
Email sako19920707@gmail.com

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
2020 Year 05 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 Preinitiation
Date of protocol fixation
2019 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 30 Day
Last follow-up date
2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 25 Day
Last modified on
2019 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041632

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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