UMIN-CTR Clinical Trial

Basic information
Public title	The influence of the limited ankle joint angle on body center of mass in the one leg standing
Acronym	The influence of the limited ankle joint angle on body center of mass in the one leg standing
Scientific Title	The influence of the limited ankle joint angle on body center of mass in the one leg standing
Scientific Title:Acronym	The influence of the limited ankle joint angle on body center of mass in the one leg standing
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Change of the center of mass sway by the difference in ankle angle
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Position of center of pressure The total trajectory length The dimension of an outer circumference area The joint angle of lower limb
Key secondary outcomes

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	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention is 2 hours per day Ankle joint angles of the ankle foot orthosis are set at dorsal flexion angle of 0 degrees, 5 degrees and 10 degrees and plantar flexion angle of 5 degrees and 10 degrees. Bare foot
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	30 years-old >=
Gender	Male and Female
Key inclusion criteria	Footedness is the right No limitation at the right ankle joint
Key exclusion criteria	Individuals have any musculoskeletal impairments in the right foot.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Shiho Middle name Last name Hosoya
Organization	Hokkaido University of Science
Division name	Department of Physical Therapy
Zip code	006-8585
Address	7-15-4-1 Maeda, Teine, Sapporo
TEL	0116887125
Email	hosoya-s@hus.ac.jp

Public contact
1st name of contact person	1st name Shiho Middle name Last name Hosoya
Organization	Hokkaido University of Science
Division name	Department of Physical Therapy
Zip code	006-8585
Address	7-15-4-1 Maeda, Teine, Sapporo
TEL	0116887125
Homepage URL
Email	hosoya-s@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)

IRB Contact (For public release)
Organization	Hokkaido University of Science
Address	7-15-4-1 Maeda, Teine, Sapporo
Tel	0116887125
Email	hosoya-s@hus.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	2017 Year 03 Month 18 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	7
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	Completed
Date of protocol fixation	2017 Year 02 Month 28 Day
Date of IRB	2017 Year 03 Month 21 Day
Anticipated trial start date	2017 Year 03 Month 21 Day
Last follow-up date	2017 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 03 Month 17 Day
Last modified on	2019 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030537