UMIN-CTR Clinical Trial

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
Email	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
Email	abahouse@belle.shiga-med.ac.jp

Sponsor
Institute	Department of Psychiatry, Shiga University of Medical Science
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054551