UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044554 |
|---|---|
| Receipt number | R000050857 |
| Scientific Title | Examination of the effect of foot training using positron emission tomography (PET) on the intrinsic muscles of the foot -to update the anterior cruciate ligament injury preventive program- |
| Date of disclosure of the study information | 2021/06/16 |
| Last modified on | 2022/01/14 12:15:32 |
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Basic information
Public title
Examination of the effect of foot training using positron emission tomography (PET) on the intrinsic muscles of the foot
-to update the anterior cruciate ligament injury preventive program-
Acronym
Examination of the effect of foot training using positron emission tomography (PET) on the intrinsic muscles of the foot
Scientific Title
Examination of the effect of foot training using positron emission tomography (PET) on the intrinsic muscles of the foot
-to update the anterior cruciate ligament injury preventive program-
Scientific Title:Acronym
Examination of the effect of foot training using positron emission tomography (PET) on the intrinsic muscles of the foot
Region
| Japan |
Condition
Condition
Anterior cruciate ligament injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the skeletal muscle activity of the foot intrinsic muscle training.
Basic objectives2
Others
Basic objectives -Others
To assess whether intrinsic foot muscle training improves risk factors for anterior cruciate ligament injury.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the lower limb skeletal muscle activities during foot intrinsic muscle training.
Key secondary outcomes
To evaluate the effect of intrinsic foot muscle training on improving risk factors for anterior cruciate ligament injury.
To evaluate changes in muscle activity patterns after 3 months of training.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is 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
| Behavior,custom |
Interventions/Control_1
Subjects perform foot intrinsic muscle training (rock-paper-scissors) for 10 minutes every day for 3 months. First, the skeletal muscle activity of the lower limbs during the initial training is evaluated using PET, and balance function. In addition, the effect of improving skeletal muscle activity and balance function after 3 months of training will be evaluated.
Interventions/Control_2
Subjects perform foot intrinsic muscle training (towel gather) for 10 minutes every day for 3 months. First, the skeletal muscle activity of the lower limbs during the initial training is evaluated using PET, and balance function. In addition, the effect of improving skeletal muscle activity and balance function after 3 months of training will be evaluated.
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
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
College student soccer player
Key exclusion criteria
Subjects with diabetes
Subjects who have injured their feet within 3 months
Subjects who are going to the hospital due to a leg injury
Subjects who have undergone PET examinations in the past and have a history of drug allergies
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Junsuke |
| Middle name | |
| Last name | Nakase |
Organization
Kanazawa University Hospital
Division name
Orthopaedics
Zip code
9208641
Address
13-1, Takara-machi,Kanazawa-shi,Ishikawa
TEL
0762642374
nakase1007@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Rikuto |
| Middle name | |
| Last name | Yoshimizu |
Organization
Kanazawa University Hospital
Division name
Orthopaedics
Zip code
9208641
Address
13-1, Takara-machi,Kanazawa-shi,Ishikawa
TEL
0762642374
Homepage URL
cogito_ergo_sum_1010@yahoo.co.jp
Sponsor or person
Institute
Kanazawa University Hospital Orthopaedics
Institute
Department
Personal name
Funding Source
Organization
Shibuya Academic Culture and Sports Promotion Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa University Clinical Trials Ethics Review Committee
Address
13-1, Takara-machi,Kanazawa-shi,Ishikawa
Tel
0762652048
hpsangak@adm.kanazawa-u.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 | 06 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
8
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
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 10 | 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 | 06 | Month | 16 | Day |
Last modified on
| 2022 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050857
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/01/14 | 研究計画書_Ver.0.0 最終.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/01/14 | 足部内在筋PET データ UMIN.xlsx |
