UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022648
Receipt number R000025905
Scientific Title Effects of physical therapy intervention by the visual feedback using the Anti-Gravity-Treadmil treadmill of compression myelopathy postoperative give the walking disorder
Date of disclosure of the study information 2016/06/20
Last modified on 2016/06/07 19:15:23

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Basic information

Public title

Effects of physical therapy intervention by the visual feedback using the Anti-Gravity-Treadmil treadmill of compression myelopathy postoperative give the walking disorder

Acronym

Effects of physical therapy intervention by the visual feedback using the Anti-Gravity-Treadmil treadmill of compression myelopathy postoperative give the walking disorder

Scientific Title

Effects of physical therapy intervention by the visual feedback using the Anti-Gravity-Treadmil treadmill of compression myelopathy postoperative give the walking disorder

Scientific Title:Acronym

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


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



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

1st name
Middle name
Last name Toshihiko Taguchi

Organization

National University Corporation Yamaguchi University Hospital length

Division name

Graduate School of Medicine orthopedics

Zip code


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

1st name
Middle name
Last name Makoto Agari

Organization

National University Corporation Yamaguchi University Hospital

Division name

Rehabilitation department

Zip code


Address

1-1-1, Minamikogushi, Ube-shi, Yamaguchi, 755-8505, Japan

TEL

0836-22-2651

Homepage URL


Email

wa.n08fk@gmail.com


Sponsor or person

Institute

National University Corporation Yamaguchi University Hospital

Institute

Department

Personal name



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)



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

2016 Year 06 Month 20 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

Preinitiation

Date of protocol fixation

2016 Year 05 Month 24 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025905


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name