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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029311
Receipt No. R000033507
Scientific Title Acute stroke rehabilitation for patients with upper limb motor dysfunction
Date of disclosure of the study information 2017/10/01
Last modified on 2019/04/02

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Basic information
Public title Acute stroke rehabilitation for patients with upper limb motor dysfunction
Acronym Stroke rehabilitation for upper limb motor dysfunction
Scientific Title Acute stroke rehabilitation for patients with upper limb motor dysfunction
Scientific Title:Acronym Stroke rehabilitation for upper limb motor dysfunction
Region
Japan

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

Objectives
Narrative objectives1 The aim of the present study is to clarify the determinants of functional recovery for patients with upper limb dysfunction with stroke rehabilitation using the visual feed back system.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Functional outcome and activity of daily living 3 month after the registration.
Key secondary outcomes 1.Cognitive function and depression scale at baseline and 3 month after the registration.
2.Total periods of intervention.
3.Motion analyses (motion capture, surface EMG)
4.Diffusion tensor imaging

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Rehabilitation with conventional therapies
Interventions/Control_2 Rehabilitation using visual feedback system
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. 18 years or older who had a informed consent.
2. Functional Ambulation Categories (FAC) 0-5
3. Patients who can sit on the chair.
Key exclusion criteria 1. consciousness disturbance.
2. Patients who cannot be undergone rehabilitation due to muscle skeletal deformity or other than stroke.
3. Liver failure, renal failure.
Target sample size 300

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
Department of Stroke rehabilitation
Institute
Department

Funding Source
Organization National Cerebral and Cardiovascular Center
Department of Stroke rehabilitation
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
2017 Year 10 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
2017 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2017 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
2017 Year 09 Month 27 Day
Last modified on
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033507

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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