UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034786
Receipt number R000039665
Scientific Title Development of a new evaluation method for leg extension muscle strength on the bed using a Pull-type hand-held dynamometer
Date of disclosure of the study information 2018/11/06
Last modified on 2020/05/15 11:30:24

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Basic information

Public title

Development of a new evaluation method for leg extension muscle strength on the bed using a Pull-type hand-held dynamometer

Acronym

Development of a new evaluation method for leg extension muscle strength on the bed using a Pull-type hand-held dynamometer

Scientific Title

Development of a new evaluation method for leg extension muscle strength on the bed using a Pull-type hand-held dynamometer

Scientific Title:Acronym

Development of a new evaluation method for leg extension muscle strength on the bed using a Pull-type hand-held dynamometer

Region

Japan


Condition

Condition

healthy adult women

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the usefulness of a new evaluation method for leg extension muscle strength on the bed using a Pull-type hand-held dynamometer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The relative reliability and the absolute reliability of a new evaluation method for leg extension muscle strength on the bed using a Pull-type hand-held dynamometer

Key secondary outcomes

The validity of a new evaluation method for leg extension muscle strength on the bed using a Pull-type hand-held dynamometer


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

evaluate leg extension muscle strength using a Pull-type hand-held dynamometer and cycle ergometer for healthy adult women

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

1) Women aged 20 years or older at the time of acquiring consent.
2) Women who give a written informed consent.

Key exclusion criteria

1) Women who have musculoskeltal diseases that cause problems in this study
2) pregnancy or possibility of pregnancy

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Iwasawa

Organization

St. Marianna University School of Medicine, Yokohama City Seibu Hospital

Division name

Rehabilitation Division

Zip code

241-0811

Address

1197-1, Yasashi-cho, Asahi-ku, Yokohama, 241-0811

TEL

045-366-1111

Email

h-iwasawa@marianna-u.ac.jp


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Iwasawa

Organization

St. Marianna University School of Medicine, Yokohama City Seibu Hospital

Division name

Rehabilitation Division

Zip code

241-0811

Address

1197-1, Yasashi-cho, Asahi-ku, Yokohama, 241-0811

TEL

045-366-1111

Homepage URL


Email

h-iwasawa@marianna-u.ac.jp


Sponsor or person

Institute

St. Marianna University School of Medicine, Yokohama City Seibu Hospital

Institute

Department

Personal name



Funding Source

Organization

St. Marianna University School of Medicine, Yokohama City Seibu Hospital

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

St. Marianna University School of Medicine, Yokohama City Seibu Hospital

Address

1197-1, Yasashi-cho, Asahi-ku, Yokohama, 241-0811

Tel

045-366-1111

Email

h-iwasawa@marianna-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

2018 Year 11 Month 06 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

16

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 11 Month 06 Day

Date of IRB

2018 Year 12 Month 19 Day

Anticipated trial start date

2018 Year 12 Month 01 Day

Last follow-up date

2020 Year 03 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

2018 Year 11 Month 06 Day

Last modified on

2020 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039665


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name