UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046013 |
|---|---|
| Receipt number | R000052515 |
| Scientific Title | Observational study about physical function and return to play in patients with ankle ligament injury based on severity of the ankle joint instability |
| Date of disclosure of the study information | 2021/11/09 |
| Last modified on | 2022/11/18 19:42:20 |
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Basic information
Public title
Assessment of physical function and return to play in patients with ankle ligament injury
Acronym
Assessment of physical function and return to play in patients with ankle ligament injury
Scientific Title
Observational study about physical function and return to play in patients with ankle ligament injury based on severity of the ankle joint instability
Scientific Title:Acronym
Observational study about physical function and return to play in patients with ankle ligament injury based on severity of the ankle joint instability
Region
| Japan |
Condition
Condition
ankle ligament injury
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate prospectively the influence of severity of ankle ligament injury on the physical function and the return to play in sports.
Basic objectives2
Others
Basic objectives -Others
Quantification of the joint instability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The period and the rate of return to play in sports
Key secondary outcomes
physical examination (range of motion, muscle strength, balance, pain, joint instability)
questionnaire
physical condition by ultrasound assessment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ankle ligament injury who had a diagnosis in Kumazawa orthopedic clinic
Key exclusion criteria
Patients with fracture, cartilage injury, or neuropathy
Not given consent
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Kawabata |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
252-0373
Address
Kanagawa prefecture, Sagamihara city, Minami ward 1-15-1, 252-0373
TEL
042-778-9968
mkawaba@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Kawabata |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
252-0373
Address
Kanagawa prefecture, Sagamihara city, Minami ward 1-15-1, 252-0373
TEL
042-778-9968
Homepage URL
mkawaba@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Allied Health Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kumazawa orthopaedics clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Allied Health Sciences institutional review board
Address
Kanagawa prefecture, Sagamihara city, Minami ward 1-15-1, 252-0373
Tel
042-778-8896
a-soumu@kitasato-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
くまざわ整形外科
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 09 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The inclusion of subjects and the follow-up period will be extended if necessary, with the approval of the Ethical Review Committee.
Management information
Registered date
| 2021 | Year | 11 | Month | 09 | Day |
Last modified on
| 2022 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052515
