UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037175 |
|---|---|
| Receipt number | 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 23:24:35 |
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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
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
sako19920707@gmail.com
Sponsor or person
Institute
Motoyama Rehabilitation Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041632
