UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040827 |
|---|---|
| Receipt number | R000044211 |
| Scientific Title | Responsibility, reliability and validity of measurement on leg extension strength in incomplete spinal cord injury- prospective cohort study- |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2022/12/26 00:04:28 |
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Basic information
Public title
Study of muscle strength in incomplete spinal cord injury
Acronym
Study of muscle strength in incomplete spinal cord injury
Scientific Title
Responsibility, reliability and validity of measurement on leg extension strength in incomplete spinal cord injury- prospective cohort study-
Scientific Title:Acronym
measurement on leg extension strength in incomplete spinal cord injury
Region
| Japan |
Condition
Condition
incomplete spinal cord injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the responsibility, reliability and validity of measurement on leg extension strength using recumbent bicycle in incomplete spinal cord injury
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Leg extention
Primary outcome is assessed before 1st assessment, and next day, 1week later, 2week later.
Key secondary outcomes
ASIA impairment scale
LEMS: Lower extremity motor score
ABMS2: Ability for Basic Movement Scale-2
WISCI: Walking index for spinal cord injury
FIM: Functional Independence measure
Secondary outcomes are assessed before 1st assessment and 1week later, 2week later, and at discharge.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients attended the inpatient rehabilitation program at the emergency and critical care center
2.First incomplete spinal cord injury
3.more than 20 years
4.stable neurological symptoms and general condition
5.No orthostatic hypotension
6.more than 95% on transcutaneous oxygen saturation, and range from 50 to 100 resting heart rate
7.history of dimentia and psychiatric disorder
8.The consent of this study was obtained
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Fukata |
Organization
Saitama Medical University International Medical Center
Division name
Department of rehabilitation center
Zip code
350-1298
Address
1397-1, Yamane, Hidaka-city, Saitama
TEL
0429844367
fkazuhiro.68@gmail.com
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Fukata |
Organization
Saitama Medical University International Medical Center
Division name
Department of rehabilitation center
Zip code
350-1298
Address
1397-1, Yamane, Hidaka-city, Saitama
TEL
0429844367
Homepage URL
fkazuhiro.68@gmail.com
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Saitama Medical University International Medical Center
Address
1397-1, Yamane, Hidaka-city, Saitama
Tel
042-984-4367
fkazuhiro.68@gmail.com
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
| 2020 | Year | 07 | 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
6
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
| 2020 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 06 | Month | 19 | Day |
Last modified on
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044211
