UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043322 |
|---|---|
| Receipt number | R000049459 |
| Scientific Title | RANDOMIZED CONTROL STUDY OF TOE EXERCISE FOR PREVENTION FROM FALL IN ELDERLY PEOPLE |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2021/02/14 11:35:34 |
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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
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
amahakentaro@gmail.com
Sponsor or person
Institute
St Lukes International University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049459
| 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 |
