UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054528 |
|---|---|
| Receipt number | R000062275 |
| Scientific Title | Characteristics of foot alignment in high school soccer players with chronic ankle instability |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/05/31 12:34:19 |
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Basic information
Public title
Characteristics of foot shape in high school soccer players with ankle instability
Acronym
Characteristics of foot shape in high school soccer players with ankle instability
Scientific Title
Characteristics of foot alignment in high school soccer players with chronic ankle instability
Scientific Title:Acronym
Characteristics of foot alignment in high school soccer players with CAI
Region
| Japan |
Condition
Condition
Chronic Ankle Instability
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify foot alignment under weight-bearing during CAI and the relationship between foot alignment and severity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lower limb alignment (calcaneal angle/Leg Heel Angle)
Measurement of one or both legs
Key secondary outcomes
Navicular Drop Test
Weight Bearing Lunge Test
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 16 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male
Key inclusion criteria
Participants were those who provided written consent from their guardians and themselves to participate in this study, had one or more ankle sprains, had experienced ankle instability "Giving Way" twice within 6 months prior to participating in the study, had two or more sprains of the same ankle as a recurrence of ankle sprains, and had a Cumberland Ankle Instability Tool score of 24 or less.
Key exclusion criteria
Those who could not obtain consent from their guardians or themselves for participation in this study, those who were unable to participate at the time of study participation, those with a history of surgery on the lower limbs, those with a history of fractures requiring reduction in the lower limbs, those who had suffered acute trauma to a lower limb joint other than the ankle joint within 3 months of participating in the study and were unable to participate in practice for at least one day, those with vestibular dysfunction, those who had a concussion within the past 3 months, and those with CAI only in the non-dominant leg.
Target sample size
63
Research contact person
Name of lead principal investigator
| 1st name | AKIHIRO |
| Middle name | AKI |
| Last name | ABE |
Organization
Kibi National University Graduate School
Division name
Graduate School of Health Sciences Department of Physical Therapy
Zip code
716-8508
Address
8 Igacho, Takahashi City, Okayama Prefecture
TEL
0866-22-9191
tsushin@kiui.ac.jp
Public contact
Name of contact person
| 1st name | AKIHIRO |
| Middle name | AKI |
| Last name | ABE |
Organization
Kibi National University Graduate School
Division name
Graduate School of Health Sciences Department of Physical Therapy
Zip code
716-8508
Address
8 Igacho, Takahashi City, Okayama Prefecture
TEL
0866-22-9191
Homepage URL
tsushin@kiui.ac.jp
Sponsor or person
Institute
Kibi National University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Kibi National University Graduate School
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
AKIHIRO ABE
Address
Ever Eden D 102, 702-10, Furukoi, Oizumi-machi, Oura-gun, Gunma Prefecture
Tel
09078028248
akihiro.abe0824@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 | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
63
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 | 12 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2024 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062275
