UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010182
Receipt number R000011924
Scientific Title Effect of the standing position exercise by the difference in sense strategy in the stroke patient
Date of disclosure of the study information 2013/04/01
Last modified on 2014/04/06 20:38:24

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Basic information

Public title

Effect of the standing position exercise by the difference in sense strategy in the stroke patient

Acronym

Effect of the standing position exercise by the difference in sense strategy in the stroke patient

Scientific Title

Effect of the standing position exercise by the difference in sense strategy in the stroke patient

Scientific Title:Acronym

Effect of the standing position exercise by the difference in sense strategy in the stroke patient

Region

Japan


Condition

Condition

Stroke

Classification by specialty

Neurology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

I clarify the effect of the standing position exercise by the difference in sense strategy in the stroke patient

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The measurements of the total trace head, the circumference area with the center of gravity unrest meter.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Intervention group practiced standing position while retaining visual feedback in the mirror.

Interventions/Control_2

The control group practiced standing holding without using a mirror.

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

A person considered that an exercise is necessary for standing position maintenance among stroke patients carrying out physiotherapy.

Key exclusion criteria

Physical condition is unstable person.
The person that it is predicted that I cause exacerbation of the remarkable change and illness of the vital signs by intervention.
The person who I have difficulty in instructions understanding by highly advanced brain functional disorder or has difficulty in concentrating on the measurement.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Keishi Takano

Organization

Saitama Medical School synthesis medical center

Division name

Rehabilitation

Zip code


Address

1981, Kamoda, Kawagoe-shi, Saitama

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Saitama Medical School synthesis medical center

Division name

Rehabilitation

Zip code


Address

1981, Kamoda, Kawagoe-shi, Saitama

TEL


Homepage URL


Email



Sponsor or person

Institute

Saitama Medical School synthesis medical center

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical School synthesis medical center

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


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

2013 Year 04 Month 01 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

Completed

Date of protocol fixation

2013 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 04 Month 01 Day

Last follow-up date

2014 Year 03 Month 31 Day

Date of closure to data entry

2014 Year 03 Month 31 Day

Date trial data considered complete

2014 Year 03 Month 31 Day

Date analysis concluded

2014 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 03 Month 06 Day

Last modified on

2014 Year 04 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011924


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name