UMIN-CTR Clinical Trial

Basic information
Public title	TOE EXERCISE FOR PREVENTION FROM FALL IN ELDERLY PEOPLE
Acronym	TOE EXERCISE FOR PREVENTION FROM FALL
Scientific Title	RANDOMIZED CONTROL STUDY OF TOE EXERCISE FOR PREVENTION FROM FALL IN ELDERLY PEOPLE
Scientific Title:Acronym	TOE EXERCISE FOR PREVENTION FROM FALL
Region	Japan

Condition
Condition	healthy elderly people
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	PREVENTION FROM FALL IN ELDERLY PEOPLE
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of falls (Monthly evaluation for one year)
Key secondary outcomes	Toe flexion strength The Timed Up and Go Test one-legged stance time Functional Reach Test Fall Efficacy Score

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Toe exercise
Interventions/Control_2	No treatment
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients over 65 years old
Key exclusion criteria	Patients with a history of foot surgery Patients with diseases of the foot that are currently being treated Patients with neurological diseases such as paralysis Patients with obvious deformities such as hallux valgus Patients who are unable to comply with the protocol
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Kentaro Middle name Last name Amaha
Organization	St Lukes International Hospital
Division name	Department of Orthopaedics Surgery
Zip code	1048560
Address	9-1 Akashicho, Chuo-ku, Tokyo
TEL	03-3541-5151
Email	amahakentaro@gmail.com

Public contact
Name of contact person	1st name Kentaro Middle name Last name Amaha
Organization	St Lukes International Hospital
Division name	Department of Orthopaedics Surgery
Zip code	1048560
Address	9-1 Akashicho, Chuo-ku, Tokyo
TEL	03-3541-5151
Homepage URL
Email	amahakentaro@gmail.com

Sponsor
Institute	St Lukes International University
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Center of St. Lukes International University
Address	9-1 Akashicho, Chuo-ku, Tokyo
Tel	03-5550-2423
Email	kenkyukikaku@luke.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	2021 Year 03 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	140
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	No longer recruiting
Date of protocol fixation	2014 Year 10 Month 14 Day
Date of IRB	2014 Year 10 Month 14 Day
Anticipated trial start date	2014 Year 10 Month 14 Day
Last follow-up date	2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 02 Month 14 Day
Last modified on	2021 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049459