UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of walking exercise prescription using antigravity treadmill for patients with walking difficulty
Title of the study (Brief title)	Development of the prescription for improvement of walking
Region	Japan

Condition
Condition	Walking disorder
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate the prescription for improvement of walking ability
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of walking by body weight reduction
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	Other
Interventions/Control_1	Treadmill walking
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	60 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with knee disorder
Key exclusion criteria	Patients with neural disorder
Target sample size	20

Research contact person
Name of lead principal investigator	Yoshinobu Ohira
Organization	Doshisha University
Division name	Faculty and Graduate School of Health & Sports Science
Address	1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL	0774-65-7163
Email	yohira@mail.doshisha.ac.jp

Public contact
Name of contact person	Tetsuya Izawa
Organization	Doshisha University
Division name	Faculty and Graduate School of Health & Sports Science
Address	1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL	0774-65-6721
Homepage URL
Email	tizawa@mail.doshisha.ac.jp

Sponsor
Institute	Doshisha University
Institute
Department

Funding Source
Organization	Doshisha University
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	2016 Year 09 Month 07 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 08 Month 23 Day
Anticipated trial start date	2016 Year 09 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 06 Day
Last modified on	2016 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027578