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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044804
Receipt No. 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

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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
Email 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/
Email jideshvv@yahoo.com

Sponsor
Institute Medical Research Centre, HAMAD MEDICAL CORPORATION
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051153

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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