UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of early movilization in patients with stroke
Title of the study (Brief title)	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	Yukihide Nishimura
Organization	Wakayama Medical University
Division name	Department of Rehabilitation Medicine
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	Yukihide Nishimura
Organization	Wakayama Medical University
Division name	Department of Rehabilitation Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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