UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049188 |
|---|---|
| Receipt number | R000055868 |
| Scientific Title | Evaluation of botulinum therapy to the lower limb for post-stroke spasticity using shear wave velocity. |
| Date of disclosure of the study information | 2022/10/11 |
| Last modified on | 2022/10/10 21:31:09 |
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Basic information
Public title
Evaluation of botulinum therapy to the lower limb for post-stroke spasticity using shear wave velocity.
Acronym
Evaluation of botulinum therapy for post-stroke spasticity using shear wave velocity.
Scientific Title
Evaluation of botulinum therapy to the lower limb for post-stroke spasticity using shear wave velocity.
Scientific Title:Acronym
Evaluation of botulinum therapy for post-stroke spasticity using shear wave velocity.
Region
| Japan |
Condition
Condition
Post Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The current study examined the effects of botulinum therapy through quantitative evaluation of spastic muscle stiffness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
spastic muscle stiffness
Key secondary outcomes
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
post-stroke paralysis of the lower limbs
Key exclusion criteria
(1) Age less than 20 years old, (2) bilateral cerebral hemispheric lesions, (3) Bilateral motor paralysis is still present, (4) Patients with a history of cervical spondylotic radiculopathy or peripheral neuropathy of the upper limbs, (5) Patients with a history of upper limb trauma or surgery.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Hasegawa |
Organization
The Jikei University School of Medicine
Division name
Department of Rehabilitaion Medicine
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-Ku Tokyo
TEL
03-3433-1111
hasegawa.yuki.reha@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Hasegawa |
Organization
The Jikei University School of Medicine
Division name
Department of Rehabilitaion Medicine
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-Ku Tokyo
TEL
03-3433-1111
Homepage URL
hasegawa.yuki.reha@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine
Department of Rehabilitaion Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
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
The Jikei University School of Medicine
Address
3-25-8, Nishi-Shimbashi, Minato-Ku Tokyo
Tel
03-3433-1111
hasegawa.yuki.reha@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
| 2022 | Year | 10 | Month | 11 | 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
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
| 2021 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 08 | 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
case series study
Management information
Registered date
| 2022 | Year | 10 | Month | 11 | Day |
Last modified on
| 2022 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055868
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
