UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of rehabilitation intervention time after botulinum treatment for spasticity
Title of the study (Brief title)	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
Name of lead principal investigator	Ryuji Kaji
Organization	Tokushima university hospital
Division name	Department of Neurology
Address	2-50-1 Kuramoto-cho, Tokushima, 770-8503, Japan
TEL	088-633-7207
Email	kajkyoto@mbox.kyoto-inet.or.jp

Public contact
Name of contact person	Takeuchi Toshiaki
Organization	Tokushima university hospital
Division name	Department of Neurology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 11 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023009