UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032088
Receipt number R000036608
Scientific Title Effect of lateral wedge for standing balance capacity in patients with acute stroke -a randomized controlled trial -
Date of disclosure of the study information 2018/04/03
Last modified on 2021/04/09 05:59:03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effect of lateral wedge for standing balance capacity in patients with acute stroke
-a randomized controlled trial -

Acronym

Effect of lateral wedge for standing balance capacity in patients with acute stroke
-a randomized controlled trial -

Scientific Title

Effect of lateral wedge for standing balance capacity in patients with acute stroke
-a randomized controlled trial -

Scientific Title:Acronym

Effect of lateral wedge for standing balance capacity in patients with acute stroke
-a randomized controlled trial -

Region

Japan


Condition

Condition

Stroke

Classification by specialty

Neurology Neurosurgery Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of lateral wedge for standing balance capacity in patients with acute stroke

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

Berg Balance Scale

Key secondary outcomes

Standing balance
Stroke Impairment Assessment Set
Trunk Control Test
Trunk Impairment Scale
Functional Ambulation Category
Functional Independence Measure
Kinematic analysis


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration


Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Experimental group
Reach exercise to non-paretic side on the lateral wedge
(30 times per session, 5 sessions a week)

Interventions/Control_2

Control group
Reach exercise to non-paretic side on the horizontal plane
(30 times per session, 5 sessions a 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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)no history of stroke
2)within 30 days from onset
3)supratentorial lesion
4)over 20 years old
5)right handed
6)stable of neurological conditions
7)no respiratory and cardiovascular diseases
8)having a hemiparesis
9)signed informed consent

Key exclusion criteria

1)cannot understand the instruction
2)having mental disease or dementia
3)cannot execute the task due to musculoskeletal disease
4)Bilateral lesions

Target sample size

52


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahide Inoue

Organization

Saitama medical university international medical center

Division name

Rehabilitation center

Zip code


Address

1397-1, Yamane, Hidaka city, Saitama

TEL

042-984-4367

Email

mm0678@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masahide Inoue

Organization

Saitama medical university international medical center

Division name

Rehabilitation center

Zip code


Address

1397-1, Yamane, Hidaka city, Saitama

TEL

042-984-4367

Homepage URL


Email

mm0678@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

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

2018 Year 04 Month 03 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

52

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

2018 Year 04 Month 03 Day

Date of IRB

2017 Year 12 Month 13 Day

Anticipated trial start date

2018 Year 04 Month 04 Day

Last follow-up date

2020 Year 02 Month 08 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 04 Month 03 Day

Last modified on

2021 Year 04 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036608


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name