UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040593 |
|---|---|
| Receipt number | R000046246 |
| Scientific Title | Mechanical stress and muscle activities of the lower limb in subjects with chronic ankle instability |
| Date of disclosure of the study information | 2020/05/31 |
| Last modified on | 2023/12/11 17:19:11 |
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Basic information
Public title
Mechanical stress and muscle activities of the lower limb in subjects with chronic ankle instability
Acronym
Mechanical stress and muscle activities of the lower limb in subjects with chronic ankle instability
Scientific Title
Mechanical stress and muscle activities of the lower limb in subjects with chronic ankle instability
Scientific Title:Acronym
Mechanical stress and muscle activities of the lower limb in subjects with chronic ankle instability
Region
| Japan |
Condition
Condition
chronic ankle instability
healthy adult
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the ankle joint mechanical stress and lower limb muscular activities in subjects with chronic ankle instability
Basic objectives2
Others
Basic objectives -Others
To assess the shock absorption characteristics and contact forces in the ankle joint in subjects with chronic ankle instability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Shock absorption characteristics
Contact forces
Lower limb muscular activities
Key secondary outcomes
Joint angles
Joint moments
Grand reaction forces
Ankle instability
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Having a history of at least one significant ankle sprain, and leading to at least one interrupted day of desired physical activity.
Having a history of the previously injured ankle joint 'giving way' and/or experiencing a recurent sprain and/or having 'feelings of instability'.
Key exclusion criteria
Having a history of fracture or surgery in the lower limb.
Acute injury to the musuloskeltal structures of othe lower extremity joints in the previous three months, and resulted in at least one interrupted day of desired physical activity.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Kasubuchi |
Organization
Kio University
Division name
Graduate School of Health Science
Zip code
635-0832
Address
4-2-2 Umami-naka Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL
+81-745-54-1601
b9975184@kio.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Kasubuchi |
Organization
Kio University
Division name
Graduate School of Health Science
Zip code
635-0832
Address
4-2-2 Umami-naka Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL
+81-745-54-1601
Homepage URL
b9975184@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
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
Kio University
Address
4-2-2 Umami-naka Koryo-cho, Kitakatsuragi-gun, Nara, Japan
Tel
+81-745-54-1601
b9975184@kio.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
| 2020 | Year | 05 | Month | 31 | 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
24
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
| 2020 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess the ankle joint mechanical stress and lower limb muscular activities in subjects with chronic ankle instability.
Management information
Registered date
| 2020 | Year | 05 | Month | 30 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046246
| Research Plan | |
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| 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 |
