UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028299 |
|---|---|
| Receipt number | R000032397 |
| Scientific Title | An effect of learning by biofeedback for short foot exercise |
| Date of disclosure of the study information | 2017/07/21 |
| Last modified on | 2019/08/26 17:47:02 |
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Basic information
Public title
An effect of learning by biofeedback for short foot exercise
Acronym
A short foot exercise with biofeedback
Scientific Title
An effect of learning by biofeedback for short foot exercise
Scientific Title:Acronym
A short foot exercise with biofeedback
Region
| Japan |
Condition
Condition
normal adult
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
intrinsic muscles training
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hight of head of metatarsal bone
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
visual biofeedback
30days
6times/min
Interventions/Control_2
EMG biofeedback
30days
6times/min
Interventions/Control_3
oral biofeedback
30days
6times/min
Interventions/Control_4
electrical stimulation biofeedback
30days
6times/min
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
flat feetn
Key exclusion criteria
normal feet
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shusaku |
| Middle name | |
| Last name | Kanai |
Organization
Prefectural University of Hiroshima
Division name
Department of Physical Therapy
Zip code
7230053
Address
Mihara City, Hiroshima-Ken
TEL
0848-60-1120
kanai@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Shusaku |
| Middle name | |
| Last name | Kanai |
Organization
Prefectural University of Hiroshima
Division name
Department of Physical Therapy
Zip code
7230053
Address
Mihara City, Hiroshima-Ken
TEL
0848-60-1120
Homepage URL
kanai@pu-hiroshima.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima
Institute
Department
Personal name
Funding Source
Organization
Prefectural University of Hiroshima
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Prefectural University of Hiroshima
Address
Mihara City, Hiroshima-Ken
Tel
0848-60-1120
kikaku2@pu-hiroshima.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
| 2017 | Year | 07 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30636725
Number of participants that the trial has enrolled
36
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 01 | Month | 04 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 20 | Day |
Last modified on
| 2019 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032397
