UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of behavior intervention in a healthy person is on the spine alignment and muscle activity
Title of the study (Brief title)	Effect of behavior intervention in a healthy person is on the spine alignment and muscle activity
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to identify changes in posture and muscle activity in order to establish effective rehabilitation program for healthy adults
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	muscle activity
Key secondary outcomes	stabilograph, Diagnostic ultrasound imaging systems,spinal mouse

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Behavior intervention
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	10 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	healthy adults
Key exclusion criteria	Orthopedic disease of the lower extremities, other neurological diseases
Target sample size	100

Research contact person
Name of lead principal investigator	Tsuyoshi Goto
Organization	Tokushima University Hospital
Division name	Departments of Rehabilitation
Address	2-50-1, Kuramoto-cho, Tokushima
TEL	+81-88-633-9313
Email	tsuyoshi.510@hotmail.com

Public contact
Name of contact person	Tsuyoshi Goto
Organization	Tokushima University Hospital
Division name	Departments of Rehabilitation
Address	2-50-1, Kuramoto-cho, Tokushima
TEL	+81-88-633-9313
Homepage URL
Email	tsuyoshi.510@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Tokushima University Hospital
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 10 Month 01 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 07 Month 13 Day
Last modified on	2016 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026672