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
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
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
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
