UMIN-CTR Clinical Trial

Basic information
Public title	The association between toe function and foot morphology, and biomechanics of the knee during walking
Acronym	The association between toe function and foot morphology, and biomechanics of the knee during walking
Scientific Title	The association between toe function and foot morphology, and biomechanics of the knee during walking
Scientific Title:Acronym	The association between toe function and foot morphology, and biomechanics of the knee during walking
Region	Japan

Condition
Condition	Osterarthritis of the knee
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the association between toe grip strength and foot morphology, and biomechanics of the knee during walking
Basic objectives2	Others
Basic objectives -Others	Biomechanical study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accerelation of the knee during walking
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	self training about strengthening exercise of the toe flexor muscle
Interventions/Control_2	control
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Community-dwelling people patients with OA of the knee
Key exclusion criteria	people with neurological deficit of the lower extremity people with history of the surgery or severe injury in their lower extremity
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Uritani
Organization	Kio University
Division name	Department of Physical Therapy, Faculty of Health Science
Zip code	6350832
Address	4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL	0745541601
Email	d.uritani@kio.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Nakayama
Organization	Kio University
Division name	Department of general affairs
Zip code	6350832
Address	4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL	0745541601
Homepage URL
Email	h.nakayama@kio.ac.jp

Sponsor
Institute	Kio University
Institute
Department

Funding Source
Organization	Kio University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Kio University
Address	4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
Tel	0745541601
Email	soumu@kio.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 02 Month 01 Day

Related information
URL releasing protocol	https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-022-05624-y
Publication of results	Published

Result
URL related to results and publications	https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-022-05624-y
Number of participants that the trial has enrolled	36
Results	Walking Staheli Arch Index (SAI) and first peak medial tibiofemoral contact force (CF) in control participants (r = -0.505, p = 0.039). SAI was also significantly positively correlated with first peak medial tibiofemoral CF in patients with knee OA (r = 0.482, p = 0.042). This study indicates that people with knee OA and flatfoot have excessive first medial tibiofemoral CF during walking.
Results date posted	2022 Year 08 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	For Knee OA group, Age > 45 years and radiographic changes with Kellgren-Lawrence (KL) grade of 2 or higher in the medial tibiofemoral compartment. For control group, the inclusion criteria were as follows: age > 45 years, walking independently without any ambulatory assistive device, and no pain in the knee joint, and we excluded those with any previous surgical treatment for the lower limbs or trunk or known neuromuscular or musculoskeletal pathologies.
Participant flow	Outpatients with Knee OA diagnosed by their treating physician in orthopedics at a Hospital and healthy adults from participants in a health promotion project conducted by a town, Nara, Japan, and from the staff members of the Hospital.
Adverse events	None
Outcome measures	tibiofemoral contact force Foot Posture Index Staheli Arch Index hallux valgus angle calcaneus inverted angle relative to the floor as a static rearfoot posture navicular height toe grip strength
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 01 Day
Date of IRB	2017 Year 02 Month 14 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 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 01 Month 26 Day
Last modified on	2022 Year 08 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029733