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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019928
Receipt No. R000023009
Scientific Title Study of rehabilitation intervention time after botulinum treatment for spasticity
Date of disclosure of the study information 2015/11/25
Last modified on 2018/05/28

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Basic information
Public title Study of rehabilitation intervention time after botulinum treatment for spasticity
Acronym Study of rehabilitation intervention time after botulinum treatment for spasticity
Scientific Title Study of rehabilitation intervention time after botulinum treatment for spasticity
Scientific Title:Acronym Study of rehabilitation intervention time after botulinum treatment for spasticity
Region
Japan

Condition
Condition spasticity
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 botulinum treatment against spasticity patients of stroke, such as central nervous system disease, to consider whether to start to functional recovery rehabilitation in different timings
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Spasticity and evaluated before the botulinum treatment in patients in outpatient for the botulinum treatment with, and evaluate treatment after one month in all groups perform different rehabilitation intervention.
Evaluation items Modified Ashworth Scale, joint range of motion, Fugel-Myer Assessment (FMA), Disabilitiy Assessment Scale (DAS), Brunnstrom stage, Visual, Analogue Scale
Such as joint range of motion and FMA so if it looks consent of the patient, to the moving image recording.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Intervention 1: immediately rehabilitation after botulinum treatment

Interventions/Control_2 Intervention 2: rehabilitation botulinum treatment after 1 week
Interventions/Control_3 Intervention 3: No rehabilitation
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
90 years-old >=
Gender Male and Female
Key inclusion criteria botulinum treatment at outpatient
Key exclusion criteria infants, pregnant women
serious systemic disease
progressive central diseases
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Ryuji Kaji
Organization Tokushima university hospital
Division name Department of Neurology
Zip code
Address 2-50-1 Kuramoto-cho, Tokushima, 770-8503, Japan
TEL 088-633-7207
Email kajkyoto@mbox.kyoto-inet.or.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takeuchi Toshiaki
Organization Tokushima university hospital
Division name Department of Neurology
Zip code
Address 2-50-1 Kuramoto-cho, Tokushima, 770-8503, Japan
TEL 088-633-7207
Homepage URL
Email takeuchi.toshiaki@tokushima-u.ac.jp

Sponsor
Institute Department of neurology, Tokushima university hospital
Institute
Department

Funding Source
Organization nothing
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
2015 Year 11 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
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 Enrolling by invitation
Date of protocol fixation
2015 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 25 Day
Last modified on
2018 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023009

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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