UMIN-CTR Clinical Trial

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
Email	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
Email	kh_ocg@yahoo.co.jp

Sponsor
Institute	Osaka City Juso Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051541