UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042591
Receipt number R000046976
Scientific Title Change of stretch reflex in central nervous system patients
Date of disclosure of the study information 2020/11/30
Last modified on 2020/12/04 08:58:42

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Basic information

Public title

Change of reflex in disease

Acronym

Change of reflex

Scientific Title

Change of stretch reflex in central nervous system patients

Scientific Title:Acronym

Change of stretch reflex

Region

Japan


Condition

Condition

central nervous system disease

Classification by specialty

Hepato-biliary-pancreatic medicine Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the influence of the pronation and supination exercise in patients with central nervous system.

Basic objectives2

Others

Basic objectives -Others

To measure the change of stretch reflex

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

change of amplitude of stretch reflex. immediate effect. every 2 weeks until 8 weeks.

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

We measure the stretch reflex before and after training. every 2 weeks until 8weeks.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with central nervous disease.

Key exclusion criteria

person with metal, pacemaker. defibrillator in the body.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Seiji
Middle name
Last name Etoh

Organization

Guraduate school of Kagoshima University

Division name

Department of physical medicine and rehabilitation

Zip code

890-8520

Address

Sakuragaoka 8-35-1, Kagoshima City, Japan

TEL

0992755339

Email

etohs@m2.kufm.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name Seiji
Middle name
Last name Etoh

Organization

Guraduate school of Kagoshima University

Division name

Department of physical medicine and rehabilitation

Zip code

890-8520

Address

Sakuragaoka 8-35-1, Kagoshima City, Japan

TEL

0992755339

Homepage URL


Email

etohs@m2.kufm.kagoshima-u.ac.jp


Sponsor or person

Institute

Guraduate school of Kagoshima University

Institute

Department

Personal name



Funding Source

Organization

Guraduate school of Kagoshima University

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

Guraduate school of Kagoshima University

Address

Sakuragaoka 8-35-1, Kagoshima City, Japan

Tel

0992755339

Email

etohs@m2.kufm.kagoshima-u.ac.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

2020 Year 11 Month 30 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

2019 Year 11 Month 01 Day

Date of IRB

2019 Year 12 Month 04 Day

Anticipated trial start date

2020 Year 11 Month 30 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 11 Month 30 Day

Last modified on

2020 Year 12 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046976


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name