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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043371
Receipt No. R000049520
Scientific Title Cumulative effect of static contraction of lower body muscle resistance on knee flexor and knee extensor strength in healthy subjects.
Date of disclosure of the study information 2021/02/19
Last modified on 2021/02/20

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Basic information
Public title Effect of pelvic exercise on knee flexion and extension
Acronym Effect of pelvic exercise on knee flexion and extension
Scientific Title Cumulative effect of static contraction of lower body muscle resistance on knee flexor and knee extensor strength in healthy subjects.
Scientific Title:Acronym Cumulative effect of static contraction of lower body muscle resistance on knee flexor and knee extensor strength in healthy subjects.
Region
Japan

Condition
Condition Healthy subjects (People who have difficulty in direct rehabilitation of the lower limbs)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effects of SCPD (Sustained contraction of posterior depression; SCPD) and SCAE (Sustained Contraction of Anterior Elevation; SCAE) on knee extension strength and knee flexion strength.

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Knee flexor muscles.
Knee extensor muscles.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 SCPD (Training intensity: 30% MVC, number of times: hold 10 times for 5 seconds).
Measure knee extension or flexion muscle strength.
Washout period (1 day).
SCAE (Training intensity: 30% MVC, number of times: 5 seconds holding 10 times).
Measure knee extension or flexion muscle strength.
Interventions/Control_2 SCAE (Training intensity: 30% MVC, number of times: hold 10 times for 5 seconds).
Measure knee extension or flexion muscle strength.
Washout period (1 day).
SCPD (Training intensity: 30% MVC, number of times: 5 seconds holding 10 times).
Measure knee extension or flexion muscle strength.

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 Male and Female
Key inclusion criteria A healthy person with the right dominant leg.
Key exclusion criteria People with a history of neurological disorders.
The person whose dominant leg is on the left.
Target sample size 32

Research contact person
Name of lead principal investigator
1st name Rui
Middle name
Last name Hobara
Organization Sonoda Second Hospital
Division name Department of Rehabilitation
Zip code 121-0813
Address 4-2-17, Takenotsuka, Adachi-ku, Tokyo, Japan.
TEL 03-3850-5723
Email daiyasan@hotmail.co.jp

Public contact
Name of contact person
1st name Rui
Middle name
Last name Hobara
Organization Sonoda Second Hospital
Division name Department of Rehabilitation
Zip code 121-0813
Address 4-2-17, Takenotsuka, Adachi-ku, Tokyo, Japan.
TEL 03-3850-5723
Homepage URL
Email daiyasan@hotmail.co.jp

Sponsor
Institute Sonoda Second Hospital
Institute
Department

Funding Source
Organization PNF Society of Japan
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 Sonodakai Joint Replacement Center Hospital
Address 1-21-10, Takenotsuka, Adachi-ku, Tokyo, Japan.
Tel 03-5831-1811
Email irb@sonodakai.or.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 02 Month 19 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 Preinitiation
Date of protocol fixation
2021 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 02 Month 19 Day
Last follow-up date
2025 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
2021 Year 02 Month 18 Day
Last modified on
2021 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049520

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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