UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The sensory stimuli induced hemodynamic responses in the cerebral cortex during the rehabilitative task
Title of the study (Brief title)	The sensory stimuli induced cortical responses
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the sensory stimuli induced cortical hemodynamic responses during the rehabilitative motor task.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The hemodynamic responses by the near-infrared spectroscopy
Key secondary outcomes	The results of motor task and the subjective assessment of sensory stimuli

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	The sensory stimuli during the motor task
Interventions/Control_2	The pseudo sensory stimuli during the motor task
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	29 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) healthy adults (20-29 years-old) (2) voluntary participation by signboard (3) obtaining the informed consent following the understanding of the research
Key exclusion criteria	(1) patient with orthopedic diseases or sensory dysfunctions related to the task-difficulties (2) diagnosis experience of psychiatry or neurology (3) student belonging to the researcher's class (4) judgement of unsuitable by the principal investigator or researcher
Target sample size	40

Research contact person
Name of lead principal investigator	Urakawa Susumu
Organization	Hiroshima Univ
Division name	Dept of Musculoskeletal Functional Research and Regeneration
Address	1-2-3, Kasumi, Minami-ku, Hiroshima
TEL	082-257-5430
Email	urkawas@hiroshima-u.ac.jp

Public contact
Name of contact person	Urakawa Susumu
Organization	Hiroshima Univ
Division name	Dept of Musculoskeletal Functional Research and Regeneration
Address	1-2-3, Kasumi, Minami-ku, Hiroshima
TEL	082-257-5430
Homepage URL
Email	urkawas@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima Univ
Institute
Department

Funding Source
Organization	Hiroshima Univ
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	広島大学

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 16 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 11 Day
Anticipated trial start date	2016 Year 11 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 11 Day
Last modified on	2016 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028533