UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019928
Receipt number 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 17:01:19

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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

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

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 or person

Institute

Department of neurology, Tokushima university hospital

Institute

Department

Personal name



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

Value
https://center6.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