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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036679
Receipt No. 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

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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
Email 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
Email tohakawa@bgu.ac.jp

Sponsor
Institute AOI Universal Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041708

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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