UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013523 |
|---|---|
| Receipt number | R000015805 |
| Scientific Title | Immediate effect of the standing position exercise being aware of the somatosensory strategy in patients with incomplete spinal cord injury |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2015/03/26 10:01:40 |
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Basic information
Public title
Immediate effect of the standing position exercise being aware of the somatosensory strategy in patients with incomplete spinal cord injury
Acronym
Immediate effect of the standing position exercise being aware of the somatosensory strategy in patients with incomplete spinal cord injury
Scientific Title
Immediate effect of the standing position exercise being aware of the somatosensory strategy in patients with incomplete spinal cord injury
Scientific Title:Acronym
Immediate effect of the standing position exercise being aware of the somatosensory strategy in patients with incomplete spinal cord injury
Region
| Japan |
Condition
Condition
Patients with incomplete spinal cord injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the this study is the immediate effect of the standing position exercise being aware of the somatosensory strategy in patients with incomplete spinal cord injury
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The measurements of the total trace head, the circumference area with the center of gravity unrest meter
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group practiced a standing position maintenance exercise while being conscious of somatosensor.
Interventions/Control_2
The control group does nothing with sitting.
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
Among patients with spinal cord injury receiving physical therapy, standing exercise is necessary
Key exclusion criteria
Physical condition is unstable person.
The person that it is predicted that I cause exacerbation of the remarkable change and illness of the vital signs by intervention.
The person who have complications to affect the standing position maintenance and the gait remarkably.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Morooka |
Organization
Saitama Medical University Faculty of Health
Division name
Department of Physical Therapy
Zip code
Address
Moroyama-cho Iruma-gun, Saitama 981 Kawakado
TEL
049-295-1001
morooka@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Morooka |
Organization
Saitama Medical University Faculty of Health
Division name
Department of Physical Therapy
Zip code
Address
Moroyama-cho Iruma-gun, Saitama 981 Kawakado
TEL
049-295-1001
Homepage URL
morooka@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Faculty of Health
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Faculty of Health
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 12 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 17 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 17 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 26 | Day |
Last modified on
| 2015 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015805
