UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000050477
Receipt number R000057496
Scientific Title Effect of Radial Extracorporeal Shock Wave Therapy on Functional Impairment and ADL Changes Caused by Spasticity in Stroke Patients
Date of disclosure of the study information 2023/03/03
Last modified on 2023/03/03 13:06:34

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Basic information

Public title

Effect of Radial Extracorporeal Shock Wave Therapy on Functional Impairment and ADL Changes Caused by Spasticity in Stroke Patients

Acronym

Effect of Radial Extracorporeal Shock Wave Therapy on Functional Impairment and ADL Changes Caused by Spasticity in Stroke Patients

Scientific Title

Effect of Radial Extracorporeal Shock Wave Therapy on Functional Impairment and ADL Changes Caused by Spasticity in Stroke Patients

Scientific Title:Acronym

Effect of Radial Extracorporeal Shock Wave Therapy on Functional Impairment and ADL Changes Caused by Spasticity in Stroke Patients

Region

Japan


Condition

Condition

Stroke

Classification by specialty

Neurology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To test whether radial extracorporeal shock wave therapy devices promote functional disability, such as spasticity, and improvement in ADLs in stroke patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Modified Ashworth Scale

Key secondary outcomes

Range of motion, Fugl-Meyer Assessment, Functional Independence Measure Motor score, Box and Block Test, 10m Walking Test, Functional Ambulation Categories


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

20 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

1. Stroke Hemiplegia
2. Modified Ashworth Scale greater than 1

Key exclusion criteria

Dementia, severe aphasia, severe sensory disturbance or pain, contracture.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Ichiro
Middle name
Last name Miyai

Organization

Morinomiya hospital

Division name

Neurorehabilitation Research Institute

Zip code

5360025

Address

2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan

TEL

06-6969-0111

Email

miyai@omichikai.or.jp


Public contact

Name of contact person

1st name Misako
Middle name
Last name Miyata

Organization

Morinomiya Hospital

Division name

Officer

Zip code

5360025

Address

2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan

TEL

06-6969-0111

Homepage URL


Email

miyata@omichikai.or.jp


Sponsor or person

Institute

Morinomiy Hospital

Institute

Department

Personal name



Funding Source

Organization

Sakai Medical Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Omichi-kai Social Medical Corporation IRB

Address

2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan

Tel

06-6969-0111

Email

nrri-jimu@omichikai.or.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

2023 Year 03 Month 03 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

2023 Year 03 Month 03 Day

Date of IRB

2023 Year 02 Month 22 Day

Anticipated trial start date

2023 Year 03 Month 03 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2023 Year 03 Month 03 Day

Last modified on

2023 Year 03 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057496