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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040183
Receipt No. R000045808
Scientific Title RANDOMIZED CONTROL STUDY OF TOE EXERCISE FOR PREVENTION FROM FALL IN ELDERLY PEOPLE
Date of disclosure of the study information 2020/05/01
Last modified on 2020/04/17

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

Condition
Condition none
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether there is a correlation with existing fall risk by measuring the flexion of the toes and to examine whether there is an effect on the actual number of falls by training the flexion of the toes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes number of falls (Evaluation every two months, up to 12 months)
Key secondary outcomes toe plantarflexion strength, FES (fall efficacy scale), functional reach test, single leg standing time, timed up and go test (Evaluation every three months, up to 12 months

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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Treatment group: Two months of foot training with the guidance of a physical therapist
Interventions/Control_2 Control: follow-up without 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 of age with no foot disease who visited orthopedic surgery at our hospita
Key exclusion criteria Patients under 65 years old, with a foot disease or a disease that interferes with the ability to walk (e.g., cerebral infarction)
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Amaha
Middle name
Last name Kentaro
Organization St Luke's International Hospital
Division name Department of Orthopedics Surgery
Zip code 1048560
Address 9-1 Akashicho, Chuo-ku, Tokyo, Japan
TEL 81-3-3541-5151
Email amaken@luke.ac.jp

Public contact
Name of contact person
1st name Arimoto
Middle name
Last name Tatsuya
Organization St Luke's International Hospital
Division name Department of Orthopedics Surgery
Zip code 1048560
Address 9-1 Akashicho, Chuo-ku, Tokyo, Japan
TEL 81-3-3541-5151
Homepage URL
Email arita@luke.ac.jp

Sponsor
Institute St Luke's International Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Institutional Review Board of St Luke's International University
Address 9-1 Akashicho, Chuo-ku, Tokyo, Japan
Tel 81-3-3543-6391
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
2020 Year 05 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 11 Month 01 Day
Last follow-up date
2021 Year 12 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
2020 Year 04 Month 17 Day
Last modified on
2020 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045808

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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