UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024655
Receipt No. R000028356
Scientific Title Managements of neuro-rehabilitation for patients with acute stroke
Date of disclosure of the study information 2016/11/01
Last modified on 2017/12/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Managements of neuro-rehabilitation for patients with acute stroke
Acronym Neuro-rehabilitation for acute strokes
Scientific Title Managements of neuro-rehabilitation for patients with acute stroke
Scientific Title:Acronym Neuro-rehabilitation for acute strokes
Region
Japan

Condition
Condition Acute stroke
Classification by specialty
Neurology Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aimed to compare the effectiveness of rehabilitation by use of robot-assisted vs. conventional therapies.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1)Functional outcome
NIHSS score
Fugl-Meyer Assessment (FMA)
Action Research Arm test (ARAT)
Functional Ambulation Categories (FAC)
10m walking (time, the number of steps)
2)Activity of daily living
modified Rankin Scale (mRS)
Functional Independence Measure (FIM)
3)Cognitive function
Mini-Mental State Examination test (MMSE)
Coloured progressive matrices by J C Raven
Behavioural Inattention Test (BIT)
4)Examination for depression
Geriatric Depression Scale (GDS)
5)Patient Reported Outcome
Decision Regret Scale (DRS)
6)Amount of rehabilitation
Period of rehabilitation
Time to first mobilization
7)Adverse events
Deterioration of neurological sign
Stroke recurrence
Onset of Cardiovascular disease
Fall
Key secondary outcomes Analysis of I diffusion tensor imaging

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
18 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria a)18 years or older who had a informed consent
b) Functional Ambulation Categories (FAC) 1-2
c) Patients who can mobile out of bed within 1 week of stroke onset
Key exclusion criteria a) consciousness disturbance
b) Patients who cannot walk due to muscle skeletal deformity or other than stroke
c) liver failure, renal failure
d) Patients who cannot undergo MRI
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chiaki Yokota
Organization National Cerebral and Cardiovascular Center
Division name Stroke rehabilitation
Zip code
Address 5-7-1, Fujishirodai, Suita, Osaka, Japan
TEL 06-6833-5012
Email cyokota@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chiaki Yokota
Organization National Cerebral and Cardiovascular Center
Division name Stroke rehabilitation
Zip code
Address 5-7-1, Fujishirodai, Suita, Osaka, Japan
TEL 06-6833-5012
Homepage URL
Email cyokota@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 11 Month 01 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
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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 10 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 10 Month 31 Day
Last modified on
2017 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028356

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.