UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031989 |
|---|---|
| Receipt number | R000036032 |
| Scientific Title | Investigation of Factors Affecting Knee Extension Limit |
| Date of disclosure of the study information | 2018/04/02 |
| Last modified on | 2023/04/11 15:22:57 |
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Basic information
Public title
Investigation of Factors Affecting Knee Extension Limit
Acronym
Investigation of Factors Affecting Knee Extension Limit
Scientific Title
Investigation of Factors Affecting Knee Extension Limit
Scientific Title:Acronym
Investigation of Factors Affecting Knee Extension Limit
Region
| Japan |
Condition
Condition
nothing special
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the influence on the knee joint function itself due to restriction of extension of the knee joint and the influence on the trunk, hip joint and ankle joint, to examine the necessity of acquiring normal range of motion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gait
Key secondary outcomes
muscle hardness,Muscular strength
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Period of intervention:after approval - March 31, 2022
Interventions/Control_2
Number of interventions:once
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1:Persons whose age is 20 years or older at the time of consent acquisition
2:Persons who do not have pain in the body
3:Those who have not restricted each joint range
4:After receiving sufficient explanation for participation in this study, patients who obtained document consent by the patient's free will with sufficient understanding
Key exclusion criteria
1:Persons who have pain in the body
2:Persons who have experienced trauma or disorder in any of the bodies
3:Other subjects who judged that the person responsible for implementation was inappropriate as the research subject
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Etsuo |
| Middle name | |
| Last name | Chosa |
Organization
Miyazaki University Medical School Hospital
Division name
Department of Rehabilitation
Zip code
889-1692
Address
5200 Kihara, Kiyotaka, Miyazaki City, Miyazaki Prefecture 889-1692
TEL
0985-85-9849
igakubu_kenkyu@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | AKio |
| Middle name | |
| Last name | Imamura |
Organization
Miyazaki University Medical School Hospital
Division name
Department of Rehabilitation
Zip code
889-1692
Address
5200 Kihara, Kiyotaka, Miyazaki City, Miyazaki Prefecture 889-1692
TEL
0985-85-9849
Homepage URL
akio_imamura@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Miyazaki University Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Miyazaki University Medical School 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
Miyazaki University Medical School Hospital
Address
5200 Kihara, Kiyotaka, Miyazaki City, Miyazaki Prefecture 889-1692
Tel
0985-85-9849
igakubu_kenkyu@med.miyazaki-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 | 04 | Month | 02 | 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
| 2018 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 02 | 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 | 03 | Month | 29 | Day |
Last modified on
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036032
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
