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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032948
Receipt No. R000037554
Official scientific title of the study muscle afferent block (MAB) therapy for upper and lower limb spasticity
Date of disclosure of the study information 2018/06/11
Last modified on 2018/06/11

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Basic information
Official scientific title of the study muscle afferent block (MAB) therapy for upper and lower limb spasticity
Title of the study (Brief title) muscle afferent block (MAB) therapy for upper and lower limb spasticity
Region
Japan

Condition
Condition upper and lower limb spasticity
Classification by specialty
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to study the most effective administration region for the treatment, muscle afferent block therapy was administered to spasticity after strokes. Subjective symptoms and objective symptoms before and after MAB therapy were evaluated and compared after proximal and distal administration.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Subjective symptoms
Changes in subjective symptoms are determined by VAS before and after treatment.
Objective symptoms
The change in objective symptoms is judged by mVAS.
Key secondary outcomes Counts dropout rate after registration.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 MAB therapy and evaluation
A. From the proximal muscle group
1.Pre-treatment video shooting, visual analog scale (VAS) evaluation
2.
MAB therapy for the tibialis posterior muscle, and the flexor digitorum superficialis muscle
3.Video shooting after treatment, VAS evaluation
4.MAB therapy for flexor digitorum brevis muscle, opponence muscle
5.Video shooting after treatment, VAS evaluation
Interventions/Control_2 B. From the distal muscle group
1.Pre-treatment video shooting, VAS evaluation
2.MAB therapy for short finger flexor muscle, thumb substitute muscle
3.Motion picture shooting after treatment, VAS evaluation
4.MAB therapy for the posterior tibialis muscle, the superficial flexor muscle
5.Movie shooting after treatment, VAS evaluation
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
16 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria 1) Cases with spasm of upper and lower limbs due to sequela such as stroke
2) 2) About participation in the study Case in which consent was obtained from the patient himself in writing
3) 3) Patients over the age of 16
Key exclusion criteria 1) under 15 years old
2) those with severe kidney failure or liver failure
3) Pregnant women and women of reproductive age who have not taken effective measures for contraception
4) Others judged to be unsuitable for this research
Target sample size 1000

Research contact person
Name of lead principal investigator matsumoto shinichi
Organization Osaka Neurological Institute
Division name Department of Neurology
Address 2-6-23, Shounai Takaramachi, Toyonaka, Osaka
TEL 06-6333-0080
Email dyt1mc@yahoo.co.jp

Public contact
Name of contact person matsumoto shinichi
Organization Osaka Neurological Institute
Division name Department of Neurology
Address 2-6-23, Shounai Takaramachi, Toyonaka, Osaka
TEL 06-6333-0080
Homepage URL
Email dyt1mc@yahoo.co.jp

Sponsor
Institute Department of Neurology, Osaka Neurological Institute,
2-6-23, Shounai Takaramachi, Toyonaka 561-0836, Japan
Institute
Department

Funding Source
Organization Department of Neurology, Osaka Neurological Institute,
2-6-23, Shounai Takaramachi, Toyonaka 561-0836, Japan
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 06 Month 11 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 30 Day
Anticipated trial start date
2018 Year 04 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
2018 Year 06 Month 11 Day
Last modified on
2018 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037554

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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