UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032948
Receipt number R000037554
Scientific Title muscle afferent block (MAB) therapy for upper and lower limb spasticity
Date of disclosure of the study information 2018/06/11
Last modified on 2023/07/25 06:21:49

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Basic information

Public title

muscle afferent block (MAB) therapy for upper and lower limb spasticity

Acronym

muscle afferent block (MAB) therapy for upper and lower limb spasticity

Scientific Title

muscle afferent block (MAB) therapy for upper and lower limb spasticity

Scientific Title:Acronym

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

1st name shinichi
Middle name
Last name matsumoto

Organization

Osaka Neurological Institute

Division name

Department of Neurology

Zip code

5610836

Address

2-6-23, Shounai Takaramachi, Toyonaka, Osaka

TEL

06-6333-0080

Email

dyt1mc@yahoo.co.jp


Public contact

Name of contact person

1st name shinichi
Middle name
Last name matsumoto

Organization

Osaka Neurological Institute

Division name

Department of Neurology

Zip code

561-0836

Address

2-6-23, Shounai Takaramachi, Toyonaka, Osaka

TEL

06-6333-0080

Homepage URL


Email

dyt1mc@yahoo.co.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization

Osaka neurological institute / IRB

Address

2-6-23, Shounai Takaramachi, Toyonaka 561-0836, Japan

Tel

06-6333-0080

Email

dyt100mc@yahoo.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 06 Month 11 Day


Related information

URL releasing protocol

https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi

Publication of results

Unpublished


Result

URL related to results and publications

https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi

Number of participants that the trial has enrolled

1000

Results

duaring the clinical trial

Results date posted

2023 Year 07 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients with spasticity of the upper and lower limbs who visited our hospital

Participant flow

Patients with upper and lower extremity spasticity who wish to participate in the trial.

Adverse events

No adverse events so far

Outcome measures

Modified visual analog scale

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2018 Year 03 Month 30 Day

Date of IRB

2018 Year 03 Month 30 Day

Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2022 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 06 Month 11 Day

Last modified on

2023 Year 07 Month 25 Day



Link to view the page

Value
https://center6.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