UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035340 |
|---|---|
| Receipt number | R000040264 |
| Scientific Title | Consolidating a quantitative evaluation of overactivity of the hemiplegic triceps surae on chronic stroke patient's ambulation. |
| Date of disclosure of the study information | 2019/01/25 |
| Last modified on | 2020/03/31 19:45:58 |
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Basic information
Public title
Consolidating a quantitative evaluation of overactivity of the hemiplegic triceps surae on chronic stroke patient's ambulation.
Acronym
Quantitative evaluation of overactivity of the hemiplegic triceps surae.
Scientific Title
Consolidating a quantitative evaluation of overactivity of the hemiplegic triceps surae on chronic stroke patient's ambulation.
Scientific Title:Acronym
Quantitative evaluation of overactivity of the hemiplegic triceps surae.
Region
| Japan |
Condition
Condition
Cerebrovascular Diseases
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine a new method for measuring overactivity of the triceps surae, and compare to modified Ashworth Scale
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
coefficient of correlation
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
measuring overactivity of the triceps surae with non-invasive device, and compare to modified Ashworth Scale
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Chronic stroke patients with hemiplegia
Key exclusion criteria
non-ambulatory patients
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikio Fujimoto |
Organization
Saitama Medical Center, Saitama medical University
Division name
Department of Rehabilitation
Zip code
Address
1981 Kamoda Kawagoe Japan
TEL
049-228-3400
m_fujimo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikio Fujimoto |
Organization
Saitama Medical Center, Saitama Medical university
Division name
Department of Rehabilitation
Zip code
Address
1981 Kamoda Kawagoe Japan
TEL
049-228-3400
Homepage URL
m_fujimo@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
the Research Foundation for Rehabilitation Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2019 | Year | 01 | Month | 25 | 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
10
Results
To be published in the original paper.
Results date posted
| 2020 | Year | 03 | Month | 31 | Day |
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
Terminated
Date of protocol fixation
| 2018 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 24 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 02 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 21 | Day |
Last modified on
| 2020 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040264
