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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030801
Receipt No. R000035131
Scientific Title A study on clinical application of IVES for patients with unilateral upper limb paralysis in chronic stroke
Date of disclosure of the study information 2018/01/14
Last modified on 2018/01/14

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Basic information
Public title A study on clinical application of IVES for patients with unilateral upper limb paralysis in chronic stroke
Acronym A study on clinical application of IVES for patients with unilateral upper limb paralysis in chronic stroke
Scientific Title A study on clinical application of IVES for patients with unilateral upper limb paralysis in chronic stroke
Scientific Title:Acronym A study on clinical application of IVES for patients with unilateral upper limb paralysis in chronic stroke
Region
Japan

Condition
Condition Stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the effectiveness of IVES for the upper limb function training of a chronic stroke unilateral upper limb paralysis patient
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes MFT(Manual function Test) after one month of upper limb function training
Key secondary outcomes MAS(Modified Ashworth Scale)
ADL(Activities of Daily Living)
Brunnstrom Stage

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The upper limb function training using IVES
60 minutes a day
Three times a week
For four weeks
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Over six months since the onset of the stroke
Unilateral upper limb paralysis (hemiplegia or upper limb paralysis)
Walking function above functional Ambulation Category 2
Possible to understand the explanation of the research and the direction of the movement
Key exclusion criteria Who may not be able to follow the instructions of therapist or doctor
Who has the possibility that exercise load cause physical activity to deteriorate
Who has tha possibility that physical condition interfere with the safe practice
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toyoko Asami
Organization Saga University Hospital
Division name Department of rehabilitation
Zip code
Address 5-1-1, Nabeshima, Saga-shi, Saga, 849-8501, Japan
TEL 0952-31-6511
Email asamit@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuki Murata
Organization Saga University Hospital
Division name Department of rehabilitation
Zip code
Address 5-1-1, Nabeshima, Saga-shi, Saga, 849-8501, Japan
TEL 0952-34-3285
Homepage URL
Email ss4512@cc.saga-u.ac.jp

Sponsor
Institute Saga University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 01 Month 14 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 Preinitiation
Date of protocol fixation
2018 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 09 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
2018 Year 01 Month 14 Day
Last modified on
2018 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035131

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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