UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of hip function using gait analysis system in hip disorder patients
Acronym	Gait analysis system for assessment of hip function
Scientific Title	Assessment of hip function using gait analysis system in hip disorder patients
Scientific Title:Acronym	Gait analysis system for assessment of hip function
Region	Japan

Condition
Condition	Hip disorders
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Use of gait analysis system for the assessment of hip function and gait appearance in hip disorder patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	For the assessment of hip function, range of motion and muscle strength in hip will be measured by motion analysis system, CT imaging, and Anybody system. For the assessment of gait appearance, body sway and stability will be measured by gait analysis system.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
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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	1. Age over 18years old 2. Patients with Hip osteoarthritis, osteonecrosis, development dysplasia of hip, limbs tear, groin pain syndrome who undergoes CT scanning. 3. Patients who can be undergone gait analysis 4. Patients who agreed with our study
Key exclusion criteria	1. Patient who are not able to walk independently 2. Patient who are judged as inappropriate by doctor
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yutaka Inaba
Organization	Yokohama City University
Division name	Department of Orthopaedic Surgery
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL	0457872655
Email	hyonmin@hotmail.com

Public contact
Name of contact person	1st name Middle name Last name Choe Hyonmin
Organization	Yokohama City University
Division name	Department of Orthopaedic Surgery
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL	0457872655
Homepage URL
Email	hyonmin@hotmail.com

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2018 Year 08 Month 22 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	Enrolling by invitation
Date of protocol fixation	2018 Year 08 Month 21 Day
Date of IRB	2018 Year 10 Month 05 Day
Anticipated trial start date	2018 Year 10 Month 05 Day
Last follow-up date	2023 Year 10 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Nothing

Management information
Registered date	2018 Year 08 Month 21 Day
Last modified on	2021 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038602