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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name