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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013441
Receipt No. R000015615
Scientific Title Oxygen uptake and metabolic equivalents of basic activities in the patients with acute hemiparetic stroke
Date of disclosure of the study information 2014/03/17
Last modified on 2016/09/17

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Basic information
Public title Oxygen uptake and metabolic equivalents of basic activities in the patients with acute hemiparetic stroke
Acronym Oxygen uptake and METs of basic activities in the patients with acute hemiparetic stroke
Scientific Title Oxygen uptake and metabolic equivalents of basic activities in the patients with acute hemiparetic stroke
Scientific Title:Acronym Oxygen uptake and METs of basic activities in the patients with acute hemiparetic stroke
Region
Japan

Condition
Condition stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate oxygen uptake and metabolic equivalents of basic activities in the patients with acute hemiparetic stroke and to compare those with healthy persons and the patients with chronic hemiparetic stroke
Basic objectives2 Others
Basic objectives -Others evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes oxygen uptake
Key secondary outcomes metabolic equivalents

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 evaluation of basic activities with expiration gas analysis(patients with acute stroke)
Interventions/Control_2 evaluation of basic activities with expiration gas analysis(healthy persons)
Interventions/Control_3 evaluation of basic activities with expiration gas analysis(patients with chronic stroke)
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 Patients with acute stroke
First ever hemiparetic patients with cerebral infarction or cerebral hemorrhage
Patients with unilateral cerebral lesion
Over 20 years old
Rehabilitation is provided at the rehabilitation center (patients can sit on a wheelchair for at least 30 minutes)
Instructions understandable
Agreed to participate in the study
Within 30 days from stroke onset

Healthy persons
Over 20 years old
No problem of basic activities and walking
Instructions understandable
Agreed to participate in the study

Patients with chronic stroke
First ever hemiparetic patients with cerebral infarction or cerebral hemorrhage
Patients with unilateral cerebral lesion
Over 20 years old
Patients can sit on a wheelchair for at least 30 minutes
Instructions understandable
Agreed to participate in the study
Over 30 days from stroke onset
Key exclusion criteria Patients with acute stroke
Heart diseases or respiratory diseases that may affect fitness such as ischemic heart disease, asthma, chronic obstructive pulmonary disease
Orthopedic diseases that may disturb movement of lower extremity such as active arthritis
Arrhythmia such as atrial fibrillation

Healthy persons
Heart diseases or respiratory diseases that may affect fitness such as ischemic heart disease, asthma, chronic obstructive pulmonary disease
Orthopedic diseases that may disturb movement of lower extremity such as active arthritis
Arrhythmia such as atrial fibrillation
History of stroke

Patients with chronic stroke
Heart diseases or respiratory diseases that may affect fitness such as ischemic heart disease, asthma, chronic obstructive pulmonary disease
Orthopedic diseases that may disturb movement of lower extremity such as active arthritis
Arrhythmia such as atrial fibrillation
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Meigen Liu
Organization Keio University School of Medicine, Japan
Division name Department of Rehabilitation Medicine
Zip code
Address 35 Shinanomati, Shinjuku-ku, Tokyo, Japan
TEL 0353633833
Email meigenliukeio@mac.com

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Tsujikawa
Organization Keio University School of Medicine, Japan
Division name Department of Rehabilitation Medicine
Zip code
Address 35 Shinanomati, Shinjuku-ku, Tokyo, Japan
TEL 0353633833
Homepage URL
Email tsujikawa-ma@hotmail.co.jp

Sponsor
Institute Keio University School of Medicine, Japan
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
Address
Tel
Email

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
2014 Year 03 Month 17 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 Terminated
Date of protocol fixation
2014 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2016 Year 09 Month 17 Day
Date of closure to data entry
2016 Year 09 Month 17 Day
Date trial data considered complete
2016 Year 09 Month 17 Day
Date analysis concluded
2016 Year 09 Month 17 Day

Other
Other related information

Management information
Registered date
2014 Year 03 Month 17 Day
Last modified on
2016 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015615

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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