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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029498
Receipt No. R000033696
Scientific Title The study of the evaluation about pattern of muscle activities and the effect of intervention using feedback of muscle activities during shoulder flexion in patients with hemiparetic stroke
Date of disclosure of the study information 2017/10/10
Last modified on 2019/03/28

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Basic information
Public title The study of the evaluation about pattern of muscle activities and the effect of intervention using feedback of muscle activities during shoulder flexion in patients with hemiparetic stroke
Acronym The study of the evaluation about pattern of muscle activities and the effect of intervention in patients with hemiparetic stroke
Scientific Title The study of the evaluation about pattern of muscle activities and the effect of intervention using feedback of muscle activities during shoulder flexion in patients with hemiparetic stroke
Scientific Title:Acronym The study of the evaluation about pattern of muscle activities and the effect of intervention in patients with hemiparetic stroke
Region
Japan

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

Objectives
Narrative objectives1 The purposes are to clarify the features of muscle activities in patients with hemiparetic stroke comparing with healthy adult, and to investigate the effect of intervention using feedback the pattern of muscle activities.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Surface EMG of the upper trapezius, pectoralis major muscle, anterior deltoid, middle deltoid posterior deltoid, and biceps brachii muscle
Key secondary outcomes

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 participants wear exoskeleton robot and muscle activities and angle of robot are measured during shoulder flexion in healthy adults and stroke patients. Next, based o the measured data, they exercise using the robot driven when appropriate pattern of muscle activities is obtained. The training time is about 30 minutes.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adults;

Stroke patients with hemiparesis;

no cognitive deficits;
less than two scores of SIAS knee-mouth test;
passive range of movement is <120 (shoulder flexion)
Key exclusion criteria (1) Contraindication to the exercise for severe heart, lung and other disease
(2) Contraindication to electric muscle stimulation
(3) Patients who can not record electroencephalogram because of epilepsy or trauma injury.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Meigen Liu
Organization Keio University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 35 Shinanomachi,Shinjyuku-ku,Tokyo, Japan
TEL 03-5363-3833
Email meigenliukeio@mac.com

Public contact
Name of contact person
1st name
Middle name
Last name Michiyuki Kawakami
Organization Keio University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 35 Shinanomachi,Shinjyuku-ku,Tokyo, Japan
TEL 03-5363-3833
Homepage URL
Email michiyukikawakami0212@yahoo.co.jp

Sponsor
Institute Department of Rehabilitation Medicine, Keio University School of Medicine
Institute
Department

Funding Source
Organization National Institute of Information and Communications Technology
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 10 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 Completed
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
2017 Year 10 Month 11 Day
Anticipated trial start date
2017 Year 10 Month 11 Day
Last follow-up date
2019 Year 03 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 10 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033696

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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