UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056292 |
|---|---|
| Receipt number | R000064323 |
| Scientific Title | Training Effect on the Abductor Hallucis Muscles by Flexion of the 1st MTP Joint in the plantar flexed position of the ankle |
| Date of disclosure of the study information | 2024/11/28 |
| Last modified on | 2025/11/29 12:42:51 |
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Basic information
Public title
Training effects of heel-raising exercises using the big toe
Acronym
Training effects of heel-raising exercises using the big toe
Scientific Title
Training Effect on the Abductor Hallucis Muscles by Flexion of the 1st MTP Joint in the plantar flexed position of the ankle
Scientific Title:Acronym
Training effects of heel-raising exercises using the big toe
Region
| Japan |
Condition
Condition
Muscle cross sectional area and strength
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate whether or not muscle hypertrophy and muscle strength improvements can be seen in the abductor hallucis muscle by performing 1st MTP joint flexion in the plantar flexion position of the ankle joint.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of muscle cross-sectional area and strength of the abductor hallucis muscle 6 weeks after the start of training
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Perform flexion exercises at the 1st MTP joint twice a week for 6 weeks. The number of repetitions per session is 30, but from the fourth week, increase by 10 each week.
Interventions/Control_2
The control group will not receive any training and will continue to live their normal lives.
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults with no history of lower limb disease.
Key exclusion criteria
Those with a history of lower limb disease.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Otani |
Organization
Nishikawa Orthopedic Clinic
Division name
Rehabilitation Department
Zip code
845-0021
Address
2171-5 Mikatsukicho-chokanda, Ogi, Saga
TEL
0952-73-8855
otani.mail@gmail.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Otani |
Organization
Nishikawa Orthopedic Clinic
Division name
Rehabilitation Department
Zip code
845-0021
Address
2171-5 Mikatsukicho-chokanda, Ogi, Saga
TEL
09056884468
Homepage URL
otani.mail@gmail.com
Sponsor or person
Institute
Nishikawa Orthopedic Clinic
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nishikawa Orthopedic Clinic
Address
2171-5 Mikatsukicho-chokanda, Ogi, Saga
Tel
0952-73-8855
otani.mail@gmail.com
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
| 2024 | Year | 11 | Month | 28 | 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
16
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Currently undergoing peer review.
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
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 28 | Day |
Last modified on
| 2025 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064323
