UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016591
Receipt number R000019252
Scientific Title Clinical trial of balance exercise "Assist"
Date of disclosure of the study information 2015/02/20
Last modified on 2017/06/29 22:40:06

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Basic information

Public title

Clinical trial of balance exercise "Assist"

Acronym

Balance Exercise Assist

Scientific Title

Clinical trial of balance exercise "Assist"

Scientific Title:Acronym

Balance Exercise Assist

Region

Japan


Condition

Condition

Stroke, Parkinson disease, Osteoarthrosis

Classification by specialty

Medicine in general Neurology Orthopedics
Neurosurgery Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the effect on balance response between ordinary exercise and exercise with barance exercise assist

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

muscle strength of lower limbs, static balance, walking speed

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

use of balance exercise assist

Interventions/Control_2

ordinary balance exercise

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with dysequilibrium

Key exclusion criteria

patients with cardiopulmonary dysfunction and severe deformities in their limbs

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masanori Nagaoka

Organization

Juntendo University

Division name

Rehabilitation Medicine

Zip code


Address

2-1-1, Hongo, Bunkyo-ku, tokyo

TEL

03-3813-3111

Email

nagaokam@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masanori Nagaoka

Organization

Juntendo University

Division name

Rehabilitation Medicine

Zip code


Address

2-1-1, Hongo, Bunkyo-ku, tokyo

TEL

03-3813-3111

Homepage URL


Email

nagaokam@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

Juntendo University, Faculty of Medicine

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

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

順天堂大学医学部附属順天堂医院


Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 20 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


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

2015 Year 02 Month 20 Day

Date of IRB


Anticipated trial start date

2015 Year 04 Month 01 Day

Last follow-up date

2016 Year 02 Month 29 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete

2017 Year 03 Month 31 Day

Date analysis concluded

2017 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 02 Month 20 Day

Last modified on

2017 Year 06 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019252


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name