UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between prefrontal cortex activation and motor function during a dual task walking
Acronym	The relationship between prefrontal cortex activation and motor function
Scientific Title	The relationship between prefrontal cortex activation and motor function during a dual task walking
Scientific Title:Acronym	The relationship between prefrontal cortex activation and motor function
Region	Japan

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

Objectives
Narrative objectives1	The difference of prefrontal cortex activation and motor function between older people and young people
Basic objectives2	Others
Basic objectives -Others	The performance of prefrontal cortex activation and walking
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prefrontal cortex activation
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Subjects are younger than 40 years old 20 years old or over Subjects are younger than 80 years old 60 years old or over
Key exclusion criteria	Orthopedics disease Neuromuscular disorders
Target sample size	36

Research contact person
Name of lead principal investigator	1st name TAKAYUKI Middle name Last name MORI
Organization	Tohoku University Graduate School
Division name	Biomedical Engineering
Zip code	9808575
Address	Aoba-ku
TEL	0227177338
Email	t-mori@med.tohoku.ac.jp

Public contact
Name of contact person	1st name TAKAYUKI Middle name Last name MORI
Organization	Tohoku University Graduate School
Division name	Biomedical Engineering
Zip code	9808575
Address	Aoba-ku
TEL	0227177338
Homepage URL
Email	t-mori@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Biomedical Engineering
Institute
Department

Funding Source
Organization	TAKENHI
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Tohoku University Graduate School of Medicine
Address	2-1 Seiryo-machi, Aoba-ku, Sendai
Tel	0227177338
Email	t-mori@med.tohoku.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	2020 Year 02 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	Enrolling by invitation
Date of protocol fixation	2019 Year 12 Month 10 Day
Date of IRB	2020 Year 01 Month 27 Day
Anticipated trial start date	2020 Year 02 Month 01 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The measurement of prefrontal cortex activation

Management information
Registered date	2019 Year 12 Month 10 Day
Last modified on	2020 Year 06 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044212