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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040827
Receipt No. 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 2020/06/19

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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
80 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
Email 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
Email fkazuhiro.68@gmail.com

Sponsor
Institute Saitama Medical University International Medical Center
Institute
Department

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
Email 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
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
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
2020 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044211

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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