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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022233
Receipt No. R000022807
Scientific Title The effect of early movilization in patients with stroke
Date of disclosure of the study information 2016/05/07
Last modified on 2019/02/25

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Basic information
Public title The effect of early movilization in patients with stroke
Acronym The effect of early movilization in patients with stroke
Scientific Title The effect of early movilization in patients with stroke
Scientific Title:Acronym The effect of early movilization in patients with stroke
Region
Japan

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

Objectives
Narrative objectives1 To study early rehabilitation in acute stroke patients improve activity of daily living during several months, but the short-term effects were not clear. The purpose of present study was to investigate the short-term effects of early rehabilitation during acute hospital stay
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes All patients were assessed Functional Independence Measure, Glasgow Coma Scale and National Institute of Health Stroke Scale on first rehabilitation and discharge. The number of death and recurrent stroke were measured.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 The patients were started rehabilitation within 24 hours from stroke onset.
Interventions/Control_2 The patients were started rehabilitation 24 to 48 hours from stroke onset.
Interventions/Control_3 The patients were started rehabilitation more than 48 hours (OM) from stroke onset.
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
18 years-old <
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients 18 years or older consecutively admitted to this hospital after stroke onset and consulted to physiatrists were screened for recruitment. Patients with cerebral infarction or intracerebral hemorrhage, and first stroke were all included
Key exclusion criteria Patients with a premorbid mRS > 4, a concurrent progressive neurologic disorder, severe heart failure, confirmed or suspected lower-limb fracture preventing mobilization, and those requiring palliative care were excluded.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihide Nishimura
Organization Wakayama Medical University
Division name Department of Rehabilitation Medicine
Zip code
Address 811-1 Kimiidera, Wakayama city, Wakayama 641-8509, Japan
TEL 073-447-2300
Email yuki-n@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihide Nishimura
Organization Wakayama Medical University
Division name Department of Rehabilitation Medicine
Zip code
Address 811-1 Kimiidera, Wakayama city,Wakayama 641-8509, Japan
TEL 073-447-2300
Homepage URL
Email yuki-n@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
Organization
Division
Category of Funding Organization Local Government
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
2016 Year 05 Month 07 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 05 Month 07 Day
Last modified on
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022807

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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