UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044577
Receipt number R000050919
Scientific Title Differences in the effects of wearing a jacket stimulating pregnancy on standing balance function.
Date of disclosure of the study information 2021/06/17
Last modified on 2022/04/13 10:27:16

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Basic information

Public title

Differences in the effects of wearing a jacket stimulating pregnancy on standing balance function.

Acronym

Differences in the effects of wearing a jacket stimulating pregnancy on standing balance function.

Scientific Title

Differences in the effects of wearing a jacket stimulating pregnancy on standing balance function.

Scientific Title:Acronym

Differences in the effects of wearing a jacket stimulating pregnancy on standing balance function.

Region

Japan


Condition

Condition

Healthy adult women

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the differences in the effects of the presence or absence of a jacket stimulating pregnancy on standing balance function in healthy adult women.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Four balance function assessment items: (1) Functional Balance Scale, (2) Timed up and Go Test, (3) Single leg standing time (eyes open and closed), (4) Two step test

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

The four balance function assessment items will be compared in two conditions: with and without a jacket stimulating pregnancy. Each of the four balance function assessments will be conducted once. The four balance function assessments are as follows: (1) Functional Balance Scale, (2) Timed up and Go Test, (3) Unilateral Stance Time (Eyes Open and Eyes Closed), and (4) Two-Step Test.

Interventions/Control_2


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

Female

Key inclusion criteria

Health adult women

Key exclusion criteria

Cognitive disorders
Movement disorders
Sensory disorder

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Yui
Middle name
Last name Abe

Organization

Hokkaido University of Science

Division name

Department of Physical Therapy Faculty of Health Sciences

Zip code

006-8585

Address

7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN

TEL

011-688-2305

Email

abe-y@hus.ac.jp


Public contact

Name of contact person

1st name Yui
Middle name
Last name Abe

Organization

Hokkaido University of Science

Division name

Department of Physical Therapy Faculty of Health Sciences

Zip code

006-8585

Address

7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN

TEL

011-688-2305

Homepage URL


Email

abe-y@hus.ac.jp


Sponsor or person

Institute

Hokkaido University of Science

Institute

Department

Personal name



Funding Source

Organization

Hokkaido University of Science

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

Hokkaido University of Science Ethics Committee

Address

7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN

Tel

011-688-2305

Email

abe-y@hus.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

2021 Year 06 Month 17 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

10

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

2021 Year 07 Month 01 Day

Date of IRB

2021 Year 06 Month 28 Day

Anticipated trial start date

2021 Year 07 Month 01 Day

Last follow-up date

2021 Year 12 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

2021 Year 06 Month 17 Day

Last modified on

2022 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050919


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name