UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038027 |
|---|---|
| Receipt number | R000043353 |
| Scientific Title | Limits of stability in various directions and total area of functional base of support while standing in community-dwelling older adults |
| Date of disclosure of the study information | 2019/09/17 |
| Last modified on | 2020/02/17 16:37:17 |
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Basic information
Public title
Limits of stability in various directions and total area of functional base of support while standing in community-dwelling older adults
Acronym
Limits of stability in various directions and total area of functional base of support while standing in community-dwelling older adults
Scientific Title
Limits of stability in various directions and total area of functional base of support while standing in community-dwelling older adults
Scientific Title:Acronym
Limits of stability in various directions and total area of functional base of support while standing in community-dwelling older adults
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine, among community-dwelling older adults, effects of aging on limits of stability in various directions and total area of functional base of support while standing.
Basic objectives2
Others
Basic objectives -Others
To examine individual differences of aging effects on limits of stability and functional base of support.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positions of center of pressure in eight stability limits and total area of functional base of support.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria for the older group were as follows: between 65 and 79 years of age; able to walk outdoors and perform daily activities without assistance or assistive devices; and not have neurological or orthopedic impairments that require current treatment. Inclusion criteria for the younger group were free of neurological or orthopedic impairments.
Key exclusion criteria
Not to fulfill inclusion criteria.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hidehito |
| Middle name | |
| Last name | Tomita |
Organization
Toyohashi SOZO University
Division name
Graduate School of Health Sciences
Zip code
440-8511
Address
20-1 Matsushita, Ushikawa-cho, Toyohashi, Japan
TEL
050-2017-2277
h_tomita@sozo.ac.jp
Public contact
Name of contact person
| 1st name | Hidehito |
| Middle name | |
| Last name | Tomita |
Organization
Toyohashi SOZO University
Division name
Graduate School of Health Sciences
Zip code
440-8511
Address
20-1 Matsushita, Ushikawa-cho, Toyohashi, Japan
TEL
050-2017-2277
Homepage URL
h_tomita@sozo.ac.jp
Sponsor or person
Institute
Graduate School of Health Sciences, Toyohashi SOZO University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Health Sciences, Toyohashi SOZO University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyohashi SOZO University
Address
20-1 Matsushita, Ushikawa-cho, Toyohashi, Japan
Tel
050-2017-2277
h_tomita@sozo.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
豊橋創造大学
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 17 | Day |
Related information
URL releasing protocol
https://www.tandfonline.com/doi/full/10.1080/00222895.2020.1723484
Publication of results
Unpublished
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/00222895.2020.1723484
Number of participants that the trial has enrolled
86
Results
The total area of functional base of support was significantly smaller in older group than in younger group. The eight stability limits were all significantly reduced in older group. However, among older participants, no significant correlations were found between the degree of reduction in the limit of stability in a certain direction and that in the opposite direction.
Results date posted
| 2019 | Year | 09 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Younger and older adults who fulfilled inclusion criteria were participated in this study.
Participant flow
By using public invitation.
Adverse events
None.
Outcome measures
Total area of functional base of support and positions of center of pressure in eight stability limits.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The total area of functional base of support was significantly smaller in older group than in younger group . The eight stability limits were all significantly reduced in older group. However, among older participants, no significant correlations were found between the degree of reduction in the limit of stability in a certain direction and that in the opposite direction.
Management information
Registered date
| 2019 | Year | 09 | Month | 17 | Day |
Last modified on
| 2020 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043353
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/09/17 | All results.xlsx |
