UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033761 |
|---|---|
| Receipt number | R000038502 |
| Scientific Title | To investigate the effects of levetiracetam on the rehabilitation outcome in patients with cerebral infarction |
| Date of disclosure of the study information | 2018/08/15 |
| Last modified on | 2024/04/05 09:56:02 |
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Basic information
Public title
To investigate the effects of levetiracetam on the rehabilitation outcome in patients with cerebral infarction
Acronym
To investigate the effects of levetiracetam on the rehabilitation outcome in patients with cerebral infarction
Scientific Title
To investigate the effects of levetiracetam on the rehabilitation outcome in patients with cerebral infarction
Scientific Title:Acronym
To investigate the effects of levetiracetam on the rehabilitation outcome in patients with cerebral infarction
Region
| Japan |
Condition
Condition
cerebral infarction
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of levetiracetam on the rehabilitation outcome in patients with cerebral infarction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional Independence Measure
Key secondary outcomes
Stroke Impairment Assessment Set
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
| Not applicable |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
SIAS < 60 and >= 25
Male or female younger than 80 years-old
patients with cerebral infarction
Key exclusion criteria
History of dementia
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Yamashiro |
Organization
Yamanashi Rehabilitation Hospital
Division name
Medical department
Zip code
4060004
Address
855, Komatu Kasugai, Fuefuki, Yamanashi, Japan
TEL
0553-26-3030
n-yamashiro@yamanashireha.p
Public contact
Name of contact person
| 1st name | Nobuo |
| Middle name | |
| Last name | Yamashiro |
Organization
Yamanashi Rehabilitation Hospital
Division name
Medical department
Zip code
4060004
Address
855, Komatu Kasugai, Fuefuki, Yamanashi, Japan
TEL
0553-26-3030
Homepage URL
n-yamashiro@yamanashireha.jp
Sponsor or person
Institute
Yamanashi Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamanashi Rehabilitation Hospital
Address
855, Komatu Kasugai, Fuefuki, Yamanashi, Japan
Tel
0553-26-3030
n-yamashiro@yamanashireha.co.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
| 2018 | Year | 08 | Month | 15 | 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
| 2018 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Medical records for 2 months
Management information
Registered date
| 2018 | Year | 08 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038502
