UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035340
Receipt number R000040264
Scientific Title Consolidating a quantitative evaluation of overactivity of the hemiplegic triceps surae on chronic stroke patient's ambulation.
Date of disclosure of the study information 2019/01/25
Last modified on 2020/03/31 19:45:58

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Basic information

Public title

Consolidating a quantitative evaluation of overactivity of the hemiplegic triceps surae on chronic stroke patient's ambulation.

Acronym

Quantitative evaluation of overactivity of the hemiplegic triceps surae.

Scientific Title

Consolidating a quantitative evaluation of overactivity of the hemiplegic triceps surae on chronic stroke patient's ambulation.

Scientific Title:Acronym

Quantitative evaluation of overactivity of the hemiplegic triceps surae.

Region

Japan


Condition

Condition

Cerebrovascular Diseases

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine a new method for measuring overactivity of the triceps surae, and compare to modified Ashworth Scale

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

coefficient of correlation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

measuring overactivity of the triceps surae with non-invasive device, and compare to modified Ashworth Scale

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

18 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Chronic stroke patients with hemiplegia

Key exclusion criteria

non-ambulatory patients

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mikio Fujimoto

Organization

Saitama Medical Center, Saitama medical University

Division name

Department of Rehabilitation

Zip code


Address

1981 Kamoda Kawagoe Japan

TEL

049-228-3400

Email

m_fujimo@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mikio Fujimoto

Organization

Saitama Medical Center, Saitama Medical university

Division name

Department of Rehabilitation

Zip code


Address

1981 Kamoda Kawagoe Japan

TEL

049-228-3400

Homepage URL


Email

m_fujimo@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

the Research Foundation for Rehabilitation Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

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

2019 Year 01 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

10

Results

To be published in the original paper.

Results date posted

2020 Year 03 Month 31 Day

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

Terminated

Date of protocol fixation

2018 Year 12 Month 21 Day

Date of IRB

2019 Year 03 Month 07 Day

Anticipated trial start date

2019 Year 03 Month 11 Day

Last follow-up date

2020 Year 01 Month 24 Day

Date of closure to data entry

2020 Year 01 Month 31 Day

Date trial data considered complete

2020 Year 01 Month 31 Day

Date analysis concluded

2020 Year 02 Month 17 Day


Other

Other related information



Management information

Registered date

2018 Year 12 Month 21 Day

Last modified on

2020 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040264


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name