UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036679 |
|---|---|
| Receipt number | R000041708 |
| Scientific Title | Motion analysis and evaluation of health status of before and after platelet-rich plasma treatment using a three-dimensional motion analysis system and MOS Short Form-36 and Western Ontario and McMaster Universities Osteoarthritis Index |
| Date of disclosure of the study information | 2019/05/20 |
| Last modified on | 2019/05/08 11:43:10 |
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Basic information
Public title
Motion analysis and evaluation of health status of before and after platelet-rich plasma treatment using a three-dimensional motion analysis system and MOS Short Form-36 and Western Ontario and McMaster Universities Osteoarthritis Index
Acronym
Motion analysis and health evaluation before and after platelet rich plasma treatment
Scientific Title
Motion analysis and evaluation of health status of before and after platelet-rich plasma treatment using a three-dimensional motion analysis system and MOS Short Form-36 and Western Ontario and McMaster Universities Osteoarthritis Index
Scientific Title:Acronym
Motion analysis and health evaluation before and after platelet rich plasma treatment
Region
| Japan |
Condition
Condition
Lower extremity musculoskeletal diseases including knee osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes before and after platelet rich plasma therapy for lower extremity musculoskeletal diseases from the viewpoint of kinematics
Basic objectives2
Others
Basic objectives -Others
To evaluate changes before and after platelet rich plasma therapy for lower extremity musculoskeletal diseases from the viewpoint of health condition
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Kinematic parameters of walking and standing
Key secondary outcomes
Scores of MOS Short Form-36 and Western Ontario and McMaster Universities Osteoarthritis Index
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Platelet Rich Plasma therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Outpatient who were treated the platelet rich plasma therapy
2. Those who have obtained consent to participate in research
Key exclusion criteria
1. Those who are dizzy frequently
2. Those who have numbness on the leg
3. Those who have a history of brain diseases such as stroke, trauma
4. Those who have a history of orthopedic surgery
5. Those who have pain that is affecting daily life
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ohkawa |
Organization
Bunkyo Gakuin University
Division name
Department of Physical Therapy
Zip code
356-8533
Address
1196 Kamekubo, Fujimino, Saitama 356-8533 Japan
TEL
049-261-7973
tohakawa@bgu.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Ohkawa |
Organization
Bunkyo Gakuin University
Division name
Department of Physical Therapy
Zip code
356-8533
Address
1196 Kamekubo, Fujimino, Saitama 356-8533 Japan
TEL
049-261-7973
Homepage URL
tohakawa@bgu.ac.jp
Sponsor or person
Institute
AOI Universal Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
AOI Universal Hospital
Address
2-9-1 Tamachi, Kawasakishi, Kawasakiku, Kanagawa, Japan
Tel
044-277-5511
kon.kun.ko@gmail.com
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
| 2019 | Year | 05 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 08 | Day |
Last modified on
| 2019 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041708
