UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040183 |
|---|---|
| Receipt number | 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 | 2024/04/20 11:25:36 |
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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
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
arita@luke.ac.jp
Sponsor or person
Institute
St Luke's International Hospital
Institute
Department
Personal name
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
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
| Delay expected |
Results Delay Reason
ysis is taking a long time.
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
| 2024 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045808
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
