UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038897 |
|---|---|
| Receipt number | R000039302 |
| Scientific Title | The evaluation of spasticity during motion by using ankle foot orthosis with ankle brake |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/12/20 16:08:53 |
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Basic information
Public title
The evaluation of spasticity during motion by using ankle foot orthosis with ankle brake
Acronym
The evaluation of spasticity during motion
Scientific Title
The evaluation of spasticity during motion by using ankle foot orthosis with ankle brake
Scientific Title:Acronym
The evaluation of spasticity during motion
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of spasticity
Basic objectives2
Others
Basic objectives -Others
development of evaluation method
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ROM of ankle
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Healthy Volunteers
Interventions/Control_2
The patient with hemiplegia
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
Healthy Volunteers
Patients with hemiplegia
Key exclusion criteria
the subject with sitting impossible
The subject with standing up impossible
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiromichi |
| Middle name | |
| Last name | Metani |
Organization
Kawasaki Medical School
Division name
Rehabilitation Medicine
Zip code
701-0192
Address
577, Matsushima, Kurasiki, Okayama, 7010192, Japan
TEL
0864621111
meta@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Hiromichi |
| Middle name | |
| Last name | Metani |
Organization
Kawasaki Medical School
Division name
Rehabilitation Medicine
Zip code
7010192
Address
577, Matsushima, Kurashiki, Okayama, 7010192, Japan
TEL
086-462-1111
Homepage URL
meta@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577, Matsushima, Kurashiki city, Okayama prefecture
Tel
0864621111
meta@med.kawasaki-m.ac.jp
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
| 2022 | Year | 04 | 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
25
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
In the middle of data analysis
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039302
