UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008323 |
|---|---|
| Receipt number | R000009750 |
| Scientific Title | The validity of evaluation method of the ability to stop walking for patients with spinal cord injury |
| Date of disclosure of the study information | 2012/07/05 |
| Last modified on | 2013/02/12 21:13:33 |
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Basic information
Public title
The validity of evaluation method of the ability to stop walking for patients with spinal cord injury
Acronym
The validity of evaluation method of the ability to stop walking for patients with spinal cord injury
Scientific Title
The validity of evaluation method of the ability to stop walking for patients with spinal cord injury
Scientific Title:Acronym
The validity of evaluation method of the ability to stop walking for patients with spinal cord injury
Region
| Japan |
Condition
Condition
Patients with spinal cord injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the assessment for stop-walking ability, this study examine the validity of the newly developed assessments, five-meter walking test and stop-walking test, subjecting for patients with spinal cord injury.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
I calculate the Pearson product moment correlation coefficient between five-meter walking test and stop-walking test,5m walking test, TUG test, the value of trunk limb muscle strength. Outlier cases were formed to consider the cause to the individual.Finally, we discuss the validity and limit of five-meter walking test and stop-walking test.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
The subjects receive sufficient explanation for the five-meter walking test and stop-walking test, 5m walking test, TUG test, the value of trunk limb muscle strength, and practice them once.The subjects conduct the tests two times with setting a sufficient rest time following with their functioning and ability. The tests are conducted in about 20 minutes including the explanation.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with spinal cord injury receiving physical therapy have more ability to walk indoors ten-meter distance with supervision.
Key exclusion criteria
Insecure subjects in acute phase after developing the symptoms and receiving operation.Subjects who are predicted to cause the significant fluctuating on vital sign and adverse events on the symptoms.Subjects who have difficulties in understanding the verbal instruction.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | koseki yousaku |
Organization
Saitama Medical University Faculty of Health
Division name
Department of Physical Therapy
Zip code
Address
Moroyama-cho Iruma-gun, Saitama 981 Kawakado
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Saitama Medical University Faculty of Health
Division name
Department of Physical Therapy
Zip code
Address
TEL
0492951001
Homepage URL
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
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
| 2012 | Year | 07 | Month | 05 | 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
| 2012 | Year | 07 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 11 | Month | 04 | Day |
Date trial data considered complete
| 2012 | Year | 11 | Month | 10 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 03 | Day |
Last modified on
| 2013 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009750
