UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022233 |
|---|---|
| Receipt number | 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 18:26:21 |
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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
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
yuki-n@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022807
