UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008323
Receipt No. 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

* 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 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
Email

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
Email

Sponsor
Institute Saitama Medical University Faculty of Health
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009750

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.