UMIN-CTR Clinical Trial

Basic information
Public title	Adjustment of motor control induced by EMG-based feedback training
Acronym	The effect of physical training used feedback system based on EMG information
Scientific Title	Adjustment of motor control induced by EMG-based feedback training
Scientific Title:Acronym	Adjustment of motor control induced by EMG-based feedback training
Region	Japan

Condition
Condition	Healthy subjects and Stroke patients
Classification by specialty	Neurology Geriatrics Neurosurgery Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to develop the novel rehabilitative training system used network analysis of the muscles-activity information measured by EMG.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Center of Pressure on the force plate Force adjustment (Target match) test EMG-EMG/EEG-EMG coherence
Key secondary outcomes	Questionnaire for Fatigue, Concentration, Sleepiness Vital sign

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Real-time feedback training through network analysis of EMG information
Interventions/Control_2	Sham control group used EMG information with noise
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	Experiment1. Healthy young adults Experiment2. Healthy young adults and Healthy elderly Experiment3. Stroke patients met the following inclusion criteria 1) Patients admitted to a convalescent rehabilitation ward 2) Patients with stable condition 3) Patients singed an informed consent document.
Key exclusion criteria	1) a clip or other metal in the skull 2) a cardiac pacemaker 3) taking medicines such as antidepressants or antipsychotics 4) Patients with epilepsy or a family history of epilepsy 5) Other subjects whose health may be affected by this research
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Ippei Middle name Last name Nojima
Organization	Shinshu University, Department of Health Sciences
Division name	Applied Physical Therapy
Zip code	390-8621
Address	3-1-1, Asahi, Matsumoto-city, Nagano, Japan
TEL	0263-37-2408
Email	nojima@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Ippei Middle name Last name Nojima
Organization	Shinshu University, Department of Health Sciences
Division name	Applied Physical Therapy
Zip code	390-8621
Address	3-1-1, Asahi, Matsumoto-city, Nagano, Japan
TEL	0263-37-2408
Homepage URL
Email	nojima@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Hospital Organization Higashinagoya National Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shinshu University, Ethics Committee
Address	3-1-1, Asahi, Matsumoto-city, Nagano, Japan
Tel	0263-37-2572
Email	mdrinri@shinshu-u.ac.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

Other administrative information
Date of disclosure of the study information	2021 Year 04 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	Open public recruiting
Date of protocol fixation	2020 Year 07 Month 01 Day
Date of IRB	2020 Year 09 Month 14 Day
Anticipated trial start date	2020 Year 11 Month 02 Day
Last follow-up date	2024 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	2020 Year 11 Month 02 Day
Last modified on	2020 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048317