UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048623
Receipt number R000055403
Scientific Title A study of physical activity and feeling of use when using plastic bottle openers
Date of disclosure of the study information 2022/08/08
Last modified on 2023/02/28 17:50:05

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Basic information

Public title

A study on ease of use of plastic bottle openers

Acronym

A study on ease of use of plastic bottle openers

Scientific Title

A study of physical activity and feeling of use when using plastic bottle openers

Scientific Title:Acronym

A study of physical activity and feeling of use when using plastic bottle openers

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the characteristics of various types of plastic bottle openers, and to obtain basic data for making decisions when selecting a plastic bottle opener and for creating a new plastic bottle opener.

Basic objectives2

Others

Basic objectives -Others

Tests to clarify usage conditions

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Muscle activity ratio

Key secondary outcomes

Range of motion ratio
Evaluating ease of use


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Individuals who gave voluntary written informed consent after receiving an adequate explanation regarding their participation in the study.

Key exclusion criteria

Individuals with limited range of motion in upper limb.
Individuals with sensory disorder and abnormal sensation in upper limb.
Individuals who have otherwise been determined to be ineligible as a subject by the principal investigator.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Hitoshi
Middle name
Last name Mutai

Organization

Shinshu University

Division name

Division of occupational therapy, School of health sciences, Faculty of Medicine

Zip code

390-8621

Address

3-1-1, Asahi, Matsumoto, Nagano, Japan

TEL

0263372405

Email

hitmutai@shinshu-u.ac.jp


Public contact

Name of contact person

1st name Hitoshi
Middle name
Last name Mutai

Organization

Shinshu University

Division name

Division of occupational therapy, School of health sciences, Faculty of Medicine

Zip code

390-8621

Address

3-1-1, Asahi, Matsumoto, Nagano, Japan

TEL

0263372405

Homepage URL


Email

hitmutai@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University

Institute

Department

Personal name



Funding Source

Organization

Shinshu University

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

The Ethics Committee of the Shinshu University School of Medicine

Address

3-1-1, Asahi, Matsumoto, Nagano, Japan

Tel

0263372572/+81263372572

Email

mdrinri@shinshu-u.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

2022 Year 08 Month 08 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

Open public recruiting

Date of protocol fixation

2022 Year 07 Month 08 Day

Date of IRB

2022 Year 07 Month 28 Day

Anticipated trial start date

2022 Year 09 Month 26 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The ease of use of the plastic bottles openers will be examined based on the evaluation of muscle activity ratio, range of motion ratio, and feeling of use.


Management information

Registered date

2022 Year 08 Month 08 Day

Last modified on

2023 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055403


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name