UMIN-CTR Clinical Trial

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