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
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
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
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
