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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042433
Receipt No. R000048441
Scientific Title Low muscle mass at admission predicts poor ADL in acute ischemic stroke.
Date of disclosure of the study information 2020/11/13
Last modified on 2020/11/12

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Basic information
Public title Low muscle mass at admission predicts poor ADL in acute ischemic stroke.
Acronym Low muscle mass at admission predicts poor ADL in acute ischemic stroke.
Scientific Title Low muscle mass at admission predicts poor ADL in acute ischemic stroke.
Scientific Title:Acronym Low muscle mass at admission predicts poor ADL in acute ischemic stroke.
Region
Japan

Condition
Condition ischemic stroke
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to clarify whether low muscle mass is a prognosis factor for ADL.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes FIM at the discharge of acute hospital
Key secondary outcomes mRS at the discharge of acute hospital

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

Not applicable
Gender Male and Female
Key inclusion criteria (1) dependent walking at admission ; (2) Measure skeletal muscle mass within 5 days of admission.
Key exclusion criteria (1) pre-stroke functional limitation (mRS score >3) ; (2) hemorrhagic infraction ; (3) other symptoms encumber walking (e.g., lower-extremity amputation, lower limb fracture, and others) ; (4) dead in the hospital ; (5) more than 3 days of intubation or 5 days of bed rest due to losing skeletal muscle mass after admission.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Yuta
Middle name
Last name Kimura
Organization Kobe city medical center general hospital
Division name Rehabilitation
Zip code 650-0047
Address 2-1-1 Minatojimaminamimachi Chuo-ku, Kobe-shi, Hyogo-ken, Japan
TEL 08074172035
Email hpm19004@nuhw.ac.jp

Public contact
Name of contact person
1st name Yuta
Middle name
Last name Kimura
Organization Kobe city medical center general hospital
Division name Rehabilitation
Zip code 650-0047
Address 2-1-1 Minatojimaminamimachi Chuo-ku, Kobe-shi, Hyogo-ken, Japan
TEL 08074172035
Homepage URL
Email hpm19004@nuhw.ac.jp

Sponsor
Institute Kobe city medical center general hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Graduate School of Health and Welfare, Niigata University of Health and Welfare
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kobe city medical center general hospital, research ethics committee
Address 2-1-1 Minatojimaminamimachi Chuo-ku, Kobe-shi, Hyogo-ken, Japan
Tel 078-302-5176
Email rinken@kcho.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 神戸市立医療センター中央市民病院

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 13 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 Preinitiation
Date of protocol fixation
2020 Year 09 Month 19 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 19 Day
Last follow-up date
2020 Year 11 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective cohort study

Management information
Registered date
2020 Year 11 Month 12 Day
Last modified on
2020 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048441

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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