UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of physical therapy intervention by the visual feedback using the Anti-Gravity-Treadmil treadmill of compression myelopathy postoperative give the walking disorder
Title of the study (Brief title)	Effects of physical therapy intervention by the visual feedback using the Anti-Gravity-Treadmil treadmill of compression myelopathy postoperative give the walking disorder
Region	Japan

Condition
Condition	Compression myelopathy
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is a prospective study involving physical therapy intervention, walking by using the Anti-Gravity Treadmill for Compression myelopathy patients are installed in our hospital, do the physical therapy intervention using visual feedback or research can contribute to the improvement of the capacity. The walking ability improved early compression myelopathy patients by performing physical therapy interventions aimed, to obtain a demonstration of the effect early intervention, also it can be expected that there can be a new therapeutic means.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	10m walking test
Key secondary outcomes	Body sway inspection Japan Orthopaedic Association score JOA Cervical Myelopathy Evaluation Questionnaire

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Intervention group the group to carry out the intervention by the visual feedback in addition to the normal physical therapy using the Anti-Gravity Treadmill, and a control group to a group to implement only the normal physical therapy.
Interventions/Control_2	The intervention group, Anti-Gravity Treadmillsettings at 20% relieving, carried out for 5 minutes at optimal walking speed (0.2 ~ 4.0km / h). Anti-Gravity Treadmill in use using a video camera, is carried out while projected to monitor the gait of the patient's own. Intervention period shall be three weeks after surgery from Anti-Gravity Treadmill available time (post-operative average length of stay in our hospital).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All cases in which surgery was performed treatment in the hospital than the preoperative diagnosis of compression myelopathy
Key exclusion criteria	1)Patients with pre-operative complications of cerebral vascular disorders 2)Patient dementia 3)Patient it is difficult to follow the inspection enforcement's instructions 4)Principal investigator or sharing deems unsuitable as a subject
Target sample size	60

Research contact person
Name of lead principal investigator	Toshihiko Taguchi
Organization	National University Corporation Yamaguchi University Hospital length
Division name	Graduate School of Medicine orthopedics
Address	1-1-1, Minamikogushi, Ube-shi, Yamaguchi, 755-8505, Japan
TEL	0836-22-2266
Email	wa.n08fk@gmail.com

Public contact
Name of contact person	Makoto Agari
Organization	National University Corporation Yamaguchi University Hospital
Division name	Rehabilitation department
Address	1-1-1, Minamikogushi, Ube-shi, Yamaguchi, 755-8505, Japan
TEL	0836-22-2651
Homepage URL
Email	wa.n08fk@gmail.com

Sponsor
Institute	National University Corporation Yamaguchi University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	National University Corporation Yamaguchi University Hospital Graduate School of Medicine orthopedics
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 06 Month 20 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 05 Month 24 Day
Anticipated trial start date	2016 Year 08 Month 01 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 06 Month 07 Day
Last modified on	2016 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025905