UMIN-CTR Clinical Trial

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
Last 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
1st 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