UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025710 |
|---|---|
| Receipt number | R000029581 |
| Scientific Title | Construction of the fall prevention programs based on analysis of mechanism of the single leg standing in the elderly |
| Date of disclosure of the study information | 2017/01/20 |
| Last modified on | 2021/02/16 12:07:06 |
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Basic information
Public title
Construction of the fall prevention programs based on analysis of mechanism of the single leg standing in the elderly
Acronym
Construction of the fall prevention programs for the elderly
Scientific Title
Construction of the fall prevention programs based on analysis of mechanism of the single leg standing in the elderly
Scientific Title:Acronym
Construction of the fall prevention programs for the elderly
Region
| Japan |
Condition
Condition
Healthy elderly
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To construct of the fall prevention programs for the elderly
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biomechanical parameters of toes during the single leg standing in the elderly
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Behavior,custom | Maneuver |
Interventions/Control_1
One grouop carries out the constructed fall prevention programs for three months
Interventions/Control_2
Another group does not carry out any interventions but recieve cross-sectional measurements
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults:
20 years old or older
Elderly:
more than 60 years old or older
No experience of any physical impairments past 6 months
Subject can perform the single leg standing more than three seconds
Key exclusion criteria
Subjects have experienced physical impairments past 6 months
Subject can perform the single leg standing less than three seconds
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoichiro |
| Middle name | |
| Last name | Sato |
Organization
Hokkaido University of Science
Division name
Health Science
Zip code
006-8585
Address
7-15-4-1 Maeda, Teine, Sapporo, 006-8585 Japan
TEL
0116887192
sato-y@hus.ac.jp
Public contact
Name of contact person
| 1st name | Yoichiro |
| Middle name | |
| Last name | Sato |
Organization
Hokkaido University of Science
Division name
Health Science
Zip code
006-8585
Address
7-15-4-1 Maeda, Teine, Sapporo, 006-8585 Japan
TEL
0116887192
Homepage URL
sato-y@hus.ac.jp
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University of Science
Address
15-4-1, Maeda 7-jo, Teine
Tel
0116882241
kenkyu@hus.ac.jp
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
北海道科学大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
no cite
Publication of results
Partially published
Result
URL related to results and publications
no cite
Number of participants that the trial has enrolled
36
Results
The function of the hallux during one-leg standing impaired in older adults compared with younger adults.
Results date posted
| 2019 | Year | 07 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy young adults and community-dwelling older adults.
Participant flow
Participants maintain one-leg standing on plantar distribution mat.
Adverse events
Possibility of the fall for the older participants.
Outcome measures
Duration of maintaining one-leg standing, coordination of toes, and coupling between toes and center of pressure.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 17 | Day |
Last modified on
| 2021 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029581
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
