UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051153