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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034786
Receipt No. R000039665
Official scientific title of the study 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 2018/11/06

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Basic information
Official scientific title of the study Development of a new evaluation method for leg extension muscle strength on the bed using a Pull-type hand-held dynamometer
Title of the study (Brief title) 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 Hiroyuki Iwasawa
Organization St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Division name Rehabilitation Division
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 Hiroyuki Iwasawa
Organization St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Division name Rehabilitation Division
Address 1197-1, Yasashi-cho, Asahi-ku, Yokohama, 241-0811
TEL 045-366-1111
Homepage URL
Email h-iwasawa@marianna-u.ac.jp

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

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 06 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 06 Day
Last modified on
2018 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.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


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