UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	On the relationship between muscle weakness of knee joint and postural sway and/or stability limit
Title of the study (Brief title)	On the relationship between muscle weakness of knee joint and postural sway and/or stability limit
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this research is to examine the influence of the muscular strength of the knee joint on the standing balance.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postural stability in standing position
Key secondary outcomes	Postural sway Stability limit Muscular strength of knee joint

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	Behavior,custom
Interventions/Control_1	Evaluation of ordinary standing and one-legged standing 1 time 2 min. period 1 day Evaluation of ordinary standing and one-legged standing when fatigue of knee extensors 1 time 50 min. period 1 day Evaluation of ordinary standing and one-legged standing 1 time 2 min. period 1 day Evaluation of ordinary standing and one-legged standing when fatigue of knee flexors 1 time 50 min. period 1 day
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	Not applicable
Gender	Female
Key inclusion criteria	Healthy adult
Key exclusion criteria	Cognitive disorders Movement disorders Sensory disorder
Target sample size	10

Research contact person
Name of lead principal investigator	Yuji Tanaka
Organization	Hokkaido University of Science
Division name	Dept. of Physical Therapy Faculty of Health Sciences
Address	7-15-4-1 Maeda, Teine, Sapporo, Hokkaido
TEL	011-688-2410
Email	tanaka-y@hus.ac.jp

Public contact
Name of contact person	Yuji Tanaka
Organization	Hokkaido University of Science
Division name	Dept. of Physical Therapy Faculty of Health Sciences
Address	7-15-4-1 Maeda, Teine, Sapporo, Hokkaido
TEL	011-688-2410
Homepage URL
Email	tanaka-y@hus.ac.jp

Sponsor
Institute	Hokkaido University of Science
Institute
Department

Funding Source
Organization	Hokkaido University of Science
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	2017 Year 03 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 31 Day
Anticipated trial start date	2018 Year 01 Month 31 Day
Last follow-up date	2018 Year 01 Month 31 Day
Date of closure to data entry	2018 Year 01 Month 31 Day
Date trial data considered complete	2018 Year 01 Month 31 Day
Date analysis concluded	2018 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	The effect of muscle fatigue was greater in the quadriceps muscle than hamstrings. In particular, the quadriceps femoris muscle affects greatly at backward moving range and speed, and the risk of falling to the rear may be high.
Other related information

Management information
Registered date	2017 Year 03 Month 15 Day
Last modified on	2018 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030496