UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047916 |
|---|---|
| Receipt number | R000054551 |
| Scientific Title | a cross-sectional study |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2022/06/01 18:25:53 |
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Basic information
Public title
Examination of the relationship between the toe gripping force of the dominant foot and the risk of falling in the community-dwelling older adults
Acronym
Examination of the relationship between the toe gripping force of the dominant foot and the risk of falling
Scientific Title
a cross-sectional study
Scientific Title:Acronym
a cross-sectional study
Region
| Japan |
Condition
Condition
in community-dwelling older adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the effect of lower limb properties (such as toe grip force, muscle strength, and plantar sensation) on the risk of falls in older adults, while considering the foot dominance and asymmetry of lower limb function.
Basic objectives2
Others
Basic objectives -Others
Relevance investigation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
toe grip force, history of falls
Key secondary outcomes
quadriceps femoris muscle strength, two-point discrimination sense, Mini-Mental State Examination (MMSE)
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
| 60 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
In community-dwelling older adults over 60 years old
Key exclusion criteria
Participants with current or previous paralysis, dizziness, body pain, limitation in range of motion, flexibility in body movements including toe and forefoot, sensory impairment, MMSE score 21 points or less.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Ozeki |
Organization
Shiga University of Medical Science
Division name
Department of Psychiatry
Zip code
520-2192
Address
Tsukinowa-cho, seta, Otsu, Shiga
TEL
077-548-2291
ozeki@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Matsuno |
Organization
Shiga University of Medical Science
Division name
Department of Psychiatry
Zip code
520-2192
Address
Tsukinowa-cho, seta, Otsu, Shiga
TEL
077-548-2291
Homepage URL
abahouse@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI (grant number: 21K17696)
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
Shiga University of Medical Science Research Ethics Committee
Address
Tsukinowa-cho, seta, Otsu, Shiga
Tel
077-548-3576
hqrec@belle.shiga-med.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | 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
54
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
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Toe grip force of the dominant foot is associated with fall risk in community-dwelling older adults
Management information
Registered date
| 2022 | Year | 06 | Month | 01 | Day |
Last modified on
| 2022 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054551
