UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040902
Receipt number R000046703
Scientific Title Effects of dynamic sitting exercise with delayed visual feedback in early phase after stroke
Date of disclosure of the study information 2020/06/26
Last modified on 2022/07/06 16:13:27

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Basic information

Public title

Effects of dynamic sitting exercise with delayed visual feedback in early phase after stroke

Acronym

Effects of dynamic sitting exercise with delayed visual feedback in early phase after stroke

Scientific Title

Effects of dynamic sitting exercise with delayed visual feedback in early phase after stroke

Scientific Title:Acronym

Effects of dynamic sitting exercise with delayed visual feedback in early phase after stroke

Region

Japan


Condition

Condition

First stroke patient with unilateral motor deficits

Classification by specialty

Neurology Neurosurgery Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of dynamic sitting exercise to anteroposterior and mediolateral direction with delayed visual feedback in early phase after stroke

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Postural Assessment Scale for Stroke

Key secondary outcomes

Dynamic sitting task
Sit-to-stand task
Change of center of pressure movement in the daily intervention
Stroke Impairment Assessment Set
Trunk Impairment Scale
Functional Ambulation Category
Functional Independence Measure - motor items


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Experimental group
Dynamic sitting exercise to anteroposterior and mediolateral direction with delayed visual feedback
(30 times for each direction per session, 5 sessions a week)

Interventions/Control_2

Control group
Dynamic sitting exercise to anteroposterior and mediolateral direction with conventional visual feedback
(30 times for each direction 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

-within 30 days from onset
-over 20 years old
-able to perform the task
-able to sit without upper limb support
-able to understand the instruction contents
-no problem for visual or visuospatial perception
-no previous history of neurological diseases other than stroke
-no orthopedic disease influenced on measurement or intervention
-signed informed consent

Key exclusion criteria

none

Target sample size

48


Research contact person

Name of lead principal investigator

1st name Masahide
Middle name
Last name Inoue

Organization

Saitama medical university international medical center

Division name

Rehabilitation center

Zip code

350-1298

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 Masahide
Middle name
Last name Inoue

Organization

Saitama medical university international medical center

Division name

Rehabilitation center

Zip code

350-1298

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

Saitama medical university international medical center clinical research IRB

Address

1397-1, Yamane, Hidaka city, Saitama

Tel

042-984-4523

Email

chikens@saitama-med.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 06 Month 26 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

27

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

Main results already published

Date of protocol fixation

2020 Year 06 Month 01 Day

Date of IRB

2020 Year 04 Month 08 Day

Anticipated trial start date

2020 Year 07 Month 10 Day

Last follow-up date

2021 Year 08 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 06 Month 25 Day

Last modified on

2022 Year 07 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046703


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name