UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043371 |
|---|---|
| Receipt number | 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 | 2022/08/26 13:09:21 |
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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
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
daiyasan@hotmail.co.jp
Sponsor or person
Institute
Sonoda Second Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2022 | 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
| 2022 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049520
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
