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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034380
Receipt No. R000039196
Scientific Title Electromyogram analysis of muscle synergy for stroke patients with hemiplegia
Date of disclosure of the study information 2018/10/05
Last modified on 2019/04/06

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Basic information
Public title Electromyogram analysis of muscle synergy for stroke patients with hemiplegia
Acronym Electromyogram analysis of muscle synergy for stroke patients
Scientific Title Electromyogram analysis of muscle synergy for stroke patients with hemiplegia
Scientific Title:Acronym Electromyogram analysis of muscle synergy for stroke patients
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to analyze the muscle synergy which is motion signal of central nerve system from stroke patient's upper extremity by surface electromyogram, and to observe the time-dependent change of same patient and the difference due to the severity.
Basic objectives2 Others
Basic objectives -Others Evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Muscle synergy
Key secondary outcomes Surface electromyogram
Motor items of Stroke Impairment Assessment Set
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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 The subject of this study is stroke patients in rehabilitation hospital. Surface electromyogram is measured while the subject moves by affixed to 6 upper extremity muscles of both (sound and affected) side. Every 20 minutes measurement per 2 weeks, total 4 times.
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

Not applicable
Gender Male and Female
Key inclusion criteria General condition is stable
Sitting position retention possible
Informed-consent has been obtained
Key exclusion criteria High-blood pressure, systolic blood pressure over 180 mmHg or diastolic blood pressure over 120 mmHg or resting heart rate over 120/min
Restricted by movement due to heart function or respiratory function disorder
hearing or visual impairment
Dementia or severe higher brain dysfunction
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Izumi
Middle name
Last name Kondo
Organization National Center for Geriatrics and Gerontology
Division name Rehabilitation Center
Zip code 474-8511
Address 7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL 0562-46-2311
Email ik7710@ncgg.go.jp

Public contact
Name of contact person
1st name Kenichi
Middle name
Last name Ozaki
Organization National Center for Geriatrics and Gerontology
Division name Rehabilitation Center
Zip code 474-8511
Address 7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL 0562-46-2311
Homepage URL
Email ozk-kety@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization TOYOTA motor corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Center for Geriatrics and Gerontology
Address 7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
Tel 0562-46-2311
Email sumiyami@ncgg.go.jp

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 国立長寿医療研究センター

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 05 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
2014 Year 04 Month 01 Day
Date of IRB
2013 Year 04 Month 23 Day
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 04 Day
Last modified on
2019 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039196

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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