UMIN-CTR Clinical Trial

Basic information
Public title	Neural mechanism of behavioral and neurophysiological changed by sensorimotor incongruence.
Acronym	Neural mechanism of behavioral and neurophysiological changed by sensorimotor incongruence.
Scientific Title	Neural mechanism of behavioral and neurophysiological changed by sensorimotor incongruence.
Scientific Title:Acronym	Neural mechanism of behavioral and neurophysiological changed by sensorimotor incongruence.
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Orthopedics Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Pathological pain and dysesthesia are caused by sensorimotor incongruence. However, it is still not clear that behavioral and neurophysiological changes caused by sensorimotor incongruence. In the present study, we clarify the neural mechanism of behavioral and neurophysiological changes using electroencephalogram.
Basic objectives2	Others
Basic objectives -Others	Pathological pain and dysesthesia are caused by sensorimotor incongruence. However, it is still not clear that behavioral and neurophysiological changes caused by sensorimotor incongruence. In the present study, we clarify the neural mechanism of behavioral and neurophysiological changes using electroencephalogram.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	dysesthesia range of motion muscle activity
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Bimanual coordination task. Mirror congruence condition.
Interventions/Control_2	Bimanual coordination task. Mirror incongruence condition.
Interventions/Control_3	Bimanual coordination task. Board congruence condition.
Interventions/Control_4	Bimanual coordination task. Board incongruence condition.
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	Participants had no current or past physical or mental illness (e.g., neurological disorders or chronic pain) and normal or corrected-to-normal vision. Demographic details including occupation and a brief medical history including hand dominance was obtained for all subjects.
Key exclusion criteria	neurological disorders or chronic pain
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Osamu Middle name Last name Katayama
Organization	Graduate School of Health Sciences, Kio University
Division name	Department of Neurorehabilitation
Zip code	635-0832
Address	4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, 635-0832, Japan.
TEL	+81745541603
Email	609.sam@gmail.com

Public contact
Name of contact person	1st name Osamu Middle name Last name Katayama
Organization	Graduate School of Health Sciences, Kio University
Division name	Department of Neurorehabilitation
Zip code	635-0832
Address	4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, 635-0832, Japan.
TEL	+81745541603
Homepage URL
Email	609.sam@gmail.com

Sponsor
Institute	Kio University
Institute
Department

Funding Source
Organization	Kio University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Kio University
Address	4-2-2 Umami-naka,, Koryo-cho, Kitakatsuragi-gun,
Tel	+81745541603
Email	609.sam@gmail.com

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	2016 Year 08 Month 07 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	2016 Year 08 Month 31 Day
Date of IRB	2016 Year 09 Month 01 Day
Anticipated trial start date	2016 Year 09 Month 30 Day
Last follow-up date	2019 Year 03 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 08 Month 07 Day
Last modified on	2020 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027097