UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045117 |
|---|---|
| Receipt number | R000051541 |
| Scientific Title | The survey of motor ability for the people who had been infected with COVID-19 |
| Date of disclosure of the study information | 2021/08/11 |
| Last modified on | 2022/02/21 20:54:43 |
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Basic information
Public title
The survey of motor ability for the people who had been infected with COVID-19
Acronym
The survey of motor ability for the patients with COVID-19
Scientific Title
The survey of motor ability for the people who had been infected with COVID-19
Scientific Title:Acronym
The survey of motor ability for the patients with COVID-19
Region
| Japan |
Condition
Condition
COVID-19 infection
Classification by specialty
| Medicine in general | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether patients been infected with COVID-19 have prolonged locomotor dysfunction or persistent musculoskeletal pain, and find the relationship with the status of return to social life
Basic objectives2
Others
Basic objectives -Others
The related factors for prolonged locomotor dysfunction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevalence of locomotive syndrome and the severity
Key secondary outcomes
persistent musculoskeletal pain, the status of return to social life (work, school, sports)
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
| 20 | years-old | <= |
Age-upper limit
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who had been finished the treatment for COVID-19 and discharged over two months before
Key exclusion criteria
The patients who do not agree with the prescribed opt-out
The patients who are in postoperative acute phase and hard to receive telephone-based medicine
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Sakawa |
Organization
Osaka City Juso Hospital
Division name
Department of Orthopedic surgery
Zip code
5320034
Address
2-12-27, Nonakakita, Yodogawa-ku, Osaka, Japan
TEL
0661508000
Akirasakawa@aol.com
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Hayashi |
Organization
Osaka City Juso Hospital
Division name
Department of Orthopedic surgery
Zip code
5320034
Address
2-12-27, Nonakakita, Yodogawa-ku, Osaka, Japan
TEL
0661508000
Homepage URL
kh_ocg@yahoo.co.jp
Sponsor or person
Institute
Osaka City Juso Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Osaka City Juso Hospital
Address
2-12-27, Nonakakita, Yodogawa-ku, Osaka, Japan
Tel
0661508000
close to public
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
大阪市立十三市民病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 11 | 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 | 08 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The survey is conducted by questionnaire
Management information
Registered date
| 2021 | Year | 08 | Month | 10 | Day |
Last modified on
| 2022 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051541
