UMIN-CTR Clinical Trial

Basic information
Public title	Balance ability and exercise capacity in patients with hallux valgus Comparison before and after surgery
Acronym	Balance ability and exercise capacity in patients with hallux valgus before and after surgery
Scientific Title	Balance ability and exercise capacity in patients with hallux valgus Comparison before and after surgery
Scientific Title:Acronym	Balance ability and exercise capacity in patients with hallux valgus before and after surgery
Region	Japan

Condition
Condition	Hallux valgus
Classification by specialty	Orthopedics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate balance ability and exercise capacity in patients with hallux valgus and to compare with healthy adults and examine the effectiveness of surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The balance ability and exercise capacity at the time of one year or more of postoperative progress are evaluated. Evaluation with plantar pressure distribution and a center-of-gravity agitation meter, a radiographic assessment, and a questionnaire are performed.
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	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	The patients that would have been hospitalized for the purpose of operative treatment for a symptomatic hallux valgus from January 2013 to December 2015 will be included in the group of hallux valgus.
Interventions/Control_2	The subjects that passed more than one year after surgery are included in the postoperative group.
Interventions/Control_3	Healthy adults without history of foot injury or complaints and obvious lower limbs deformity on inspection are included in control group.
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	The patients that have been hospitalized for the purpose of operative treatment for a symptomatic hallux valgus are included in the group of hallux valgus. The subjects that passed more than one year after surgery are included in the postoperative group. Healthy adults without history of lower limbs injury or complaints and obvious lower limbs deformity on inspection are included in control group.
Key exclusion criteria	The subjects with history of lower limbs injury or surgery and have a neurological disorder are excluded.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masashi Neo
Organization	Osaka Medical College
Division name	Department of Orthopedic Surgery
Zip code
Address	2-7, Daigaku-machi, Takatsuki-shi, Osaka, Japan
TEL	072-683-1221
Email	neo@poh.osaka-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Jotoku Tsuyoshi
Organization	Osaka Medical College
Division name	Department of Orthopedic Surgery
Zip code
Address	2-7, Daigaku-machi, Takatsuki-shi, Osaka, Japan
TEL	072-683-1221
Homepage URL
Email	ort032@poh.osaka-med.ac.jp

Sponsor
Institute	Department of Orthopedic Surgery, Osaka Medical College
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2013 Year 11 Month 28 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
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	2013 Year 01 Month 07 Day
Date of IRB	2013 Year 01 Month 07 Day
Anticipated trial start date	2013 Year 01 Month 07 Day
Last follow-up date	2020 Year 06 Month 18 Day
Date of closure to data entry	2020 Year 06 Month 18 Day
Date trial data considered complete	2020 Year 06 Month 18 Day
Date analysis concluded	2020 Year 06 Month 18 Day

Other
Other related information

Management information
Registered date	2013 Year 11 Month 28 Day
Last modified on	2020 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014544