UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Quantitative analysis of trunk muscles activities by surface EMG
Title of the study (Brief title)	Quantitative s-EMG analysis of trunk muscles
Region	Japan

Condition
Condition	Healthy subjects and patients with disuse syndrome
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Trunk muscles are important to perform various limb movements. Several methods for strengthening these muscles are introduced in the field of sports. Quantitative assessment is needed to have for comparison of the effectiveness of each method. Surface EMG might be a such tool.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	To test the linearity between force level and surface EMG
Key secondary outcomes	Test of reciprocity and cocontraction between rectus abdominis and paralumbar muscles

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Crunch exercise
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Normal subjects Outpatients with disuse syndrome
Key exclusion criteria	Patients with Low back pain Neurorogiical patients and orthopedic patients Patients with restriction of strong exercise
Target sample size	15

Research contact person
Name of lead principal investigator	Masanori Nagaoka
Organization	Juntendo University
Division name	Department of Rehabilitation Medicine
Address	2-1-1, Hongo, Bunkyo-ku, tokyo
TEL	09026373079
Email	nagaokam@juntendo.ac.jp

Public contact
Name of contact person	Masanori Nagaoka
Organization	Juntendo University
Division name	Rehabilitation Medicine
Address	2-1-1, Hongo, Bunkyo-ku, tokyo
TEL	09026373079
Homepage URL
Email	nagaokam@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Juntendo University
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	順天堂大学医学部附属順天堂医院（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 01 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2017 Year 02 Month 28 Day
Date of closure to data entry	2017 Year 02 Month 28 Day
Date trial data considered complete	2017 Year 02 Month 28 Day
Date analysis concluded	2017 Year 03 Month 01 Day

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

Management information
Registered date	2017 Year 01 Month 05 Day
Last modified on	2018 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029407