UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000015948
Receipt number	R000018545
Scientific Title	Does training sitting balance on a platform tilted 10 degrees to the weak side improve trunk control in the acute phase after stroke? A randomized, controlled trial
Date of disclosure of the study information	2014/12/15
Last modified on	2014/12/15 11:42:54

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Basic information

Public title

Does training sitting balance on a platform tilted 10 degrees to the weak side improve trunk control in the acute phase after stroke? A randomized, controlled trial

Acronym

Does training sitting balance on a platform tilted 10 degrees to the weak side improve trunk control in the acute phase after stroke? A randomized, controlled trial

Scientific Title

Does training sitting balance on a platform tilted 10 degrees to the weak side improve trunk control in the acute phase after stroke? A randomized, controlled trial

Scientific Title:Acronym

Does training sitting balance on a platform tilted 10 degrees to the weak side improve trunk control in the acute phase after stroke? A randomized, controlled trial

Region

Japan

Condition

Acute stroke patients

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To compare the effectiveness of training sitting balance on a platform tilted 10 degrees to the weak side and on a horizontal platform in stroke patients.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Stroke Impairment Assessment Set
Trunk Control Test
Motion analysis

Key secondary outcomes

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

The experimental group sat without leg support on a platform tilted 10 degrees to the paretic side in the frontal plane. They were asked to move their trunk laterally from the paretic side to the non-paretic side. This training was performed 60 times per session, with 6 sessions in one week.

Interventions/Control_2

The control group sat without leg support on a horizontal platform. They were asked to move their trunk laterally from the paretic side to the non-paretic side. This training was performed 60 times per session, with 6 sessions in one week.

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) no past history of stroke
(2) supratentorial lesion of the brain
(3) stable neurological symptoms and general condition
(4) ability to sit without support
(5) the trunk control test was not maximal at the start of study
(6) no dementia or psychiatric disorder
(7) ability to understand instructions
(8) no orthopedic problem that would interfere with the ability to perform lateral sitting training
(9) able to provide informed consent

Key exclusion criteria

Cases that do not meet the inclusion criteria.

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Yuji Fujino

Organization

Saitama Medical University International Medical Center

Division name

Department of Rehabilitation

Zip code

Address

1397-1, Yamane, Hidaka, Saitama 350-1298, Japan

TEL

042-984-4367

Email

yujifuji@saitama-med.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Yuji Fujino

Organization

Saitama Medical University International Medical Center

Division name

Department of Rehabilitation

Zip code

Address

1397-1, Yamane, Hidaka, Saitama 350-1298, Japan

TEL

042-984-4367

Homepage URL

Email

yujifuji@saitama-med.ac.jp

Sponsor or person

Institute

Saitama Medical University International Medical Center

Institute

Department

Personal name

Funding Source

Organization

none

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

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2014 Year 12 Month 15 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

2010 Year 04 Month 01 Day

Date of IRB

Anticipated trial start date

2010 Year 06 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

2014 Year 12 Month 15 Day

Last modified on

2014 Year 12 Month 15 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018545

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name