UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003575
Receipt number R000004336
Scientific Title The effect of trunk facilitation in post-stroke patients
Date of disclosure of the study information 2010/05/07
Last modified on 2014/11/09 19:37:48

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Basic information

Public title

The effect of trunk facilitation in post-stroke patients

Acronym

Effect of trunk facilitation

Scientific Title

The effect of trunk facilitation in post-stroke patients

Scientific Title:Acronym

Effect of trunk facilitation

Region

Japan


Condition

Condition

Post-stroke patients

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of trunk facilitation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Muscle strength, Functional Assessment For Control Trunk, Berg Balance Scale, Functional Reach Test, 10m gait measurement, Functional Independence Measure

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Trunk facilitation technique

Interventions/Control_2

Without trunk facilitation technique

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Post-stroke patinets whoes onset between 1 and 6 months

Key exclusion criteria

Severe higher brain dysfunction, Severe dementia, Loss of consciousness

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shuji Matsumoto

Organization

Kagoshima University

Division name

Department of Physical Medicine and Rehabilitation

Zip code


Address

3930-7 Takachiho, Makizono-cho, Kirishima City

TEL

0995-78-2538

Email

shushu@m.kufm.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shuji Matsumoto

Organization

Kagoshima University

Division name

Department of Physical Medicine and Rehabilitation

Zip code


Address

3930-7 Takachiho, makizono-cho, Kirishima City

TEL

0995-78-2538

Homepage URL


Email

shushu@m.kufm.kagoshima-u.ac.jp


Sponsor or person

Institute

Kagoshima University

Institute

Department

Personal name



Funding Source

Organization

None

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

2010 Year 05 Month 07 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

2010 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 05 Month 07 Day

Last modified on

2014 Year 11 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004336


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name