UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013441 |
|---|---|
| Receipt number | 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 09:46:51 |
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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
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
tsujikawa-ma@hotmail.co.jp
Sponsor or person
Institute
Keio University School of Medicine, Japan
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015615
