UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044804 |
|---|---|
| Receipt number | R000051153 |
| Scientific Title | Outcome Of Acute Stroke Patients Undergoing Functional Rehabilitation Based On Timing Of The Initiation Of Therapy: A Multidisciplinary Clinical Trial |
| Date of disclosure of the study information | 2021/07/08 |
| Last modified on | 2021/07/08 20:27:29 |
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Basic information
Public title
Early Mobilisation For People After Acute Ischemic Stroke
Acronym
EMAIS
Scientific Title
Outcome Of Acute Stroke Patients Undergoing Functional Rehabilitation Based On Timing Of The Initiation Of Therapy: A Multidisciplinary Clinical Trial
Scientific Title:Acronym
Outcome Of Acute Stroke Patients Undergoing Functional Rehabilitation Based On Timing Of The Initiation Of Therapy: A Multidisciplinary Clinical Trial
Region
| Asia(except Japan) |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the outcomes of subjects mobilised within 24 hrs of stroke symptom onset (VEM group) with those subjects mobilised after 24 hrs (24 hrs to 48 hrs period) of symptom onset (Early mobilization group).
Basic objectives2
Others
Basic objectives -Others
To compare the effects of early mobilization on all the 3 levels of severity of acute stroke patients namely mild, moderate and severe in the context of a routine clinical setting.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mobility Scale for Acute Stroke Patients
Key secondary outcomes
Number of adverse events during the study period.
The number of mobilisation sessions differed due to unstable patient status.
Canadian Neurological Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Very early mobilization of acute ischemic stroke patients. Patients will be mobilised within 24hours of symptom onset. Mobilsiation will be provided for first 7 days or up to discharge, if discharged prior to 7 days.
Interventions/Control_2
Early mobilisation of acute ischemic stroke patients. Patients will be mobilised within 24 to 48hours of symptom onset.Mobilsiation will be provided for first 7 days or up to discharge, if discharged prior to 7 days.
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
| Not applicable |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
should react to verbal commands.
Systolic blood pressure should be between 110 and 180 mm Hg.
oxygen saturation of more than 92%
Heart rate should be between 40 and 100 beats per minute
Key exclusion criteria
Transient ischemic attack and hemorrhagic stroke.
Premorbid modified Rankin Scale (mRS) score more than 3
Musculoskeletal problem (like fracture) preventing mobilisation, associated progressive neurological condition, acute coronary syndrome, heart failure and pregnant women
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | JIDESH |
| Middle name | VALIPARAMBIL |
| Last name | VISWAMBHARAN |
Organization
HAMAD MEDICAL CORPORATION
Division name
HAMAD GENERAL HOSPITAL, DEPARTMENT OF PHYSIOTHERAPY
Zip code
3050
Address
Department of Physiotherapy, Hamad General Hospital, DOHA, QATAR
TEL
+97455221738
jideshvv@yahoo.com
Public contact
Name of contact person
| 1st name | JIDESH |
| Middle name | VALIPARAMBIL |
| Last name | VISWAMBHARAN |
Organization
HAMAD MEDICAL CORPORATION
Division name
HAMAD GENERAL HOSPITAL, DEPARTMENT OF PHYSIOTHERAPY
Zip code
3050
Address
Department of Physiotherapy, Hamad General Hosptial, Doha, Qatar
TEL
00974-55221738
Homepage URL
https://www.hamad.qa/
jideshvv@yahoo.com
Sponsor or person
Institute
Medical Research Centre, HAMAD MEDICAL CORPORATION
Institute
Department
Personal name
Funding Source
Organization
Medical Research Centre, Hamad Medical Corporation, Qatar
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Qatar
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Centre, Hamad Medical Corporation, Qatar
Address
PO 3050, IRB, Medical Research Centre, Hamad Medical Corporation, Qatar
Tel
00974-40256410
irb@hamad.qa
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
Hamad General Hosptial (Qatar)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 08 | 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
300
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
| 2017 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 08 | Day |
Last modified on
| 2021 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051153
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