UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035582 |
|---|---|
| Receipt number | R000040548 |
| Scientific Title | Verification of the effect of Functional Electrical Stimulation on knee varus thrust aimed to prevent the progression of knee osteoarthritis |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2024/04/23 13:57:54 |
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Basic information
Public title
Verification of the effect of Functional Electrical Stimulation on knee varus thrust aimed to prevent the progression of knee osteoarthritis
Acronym
FES trial for knee OA
Scientific Title
Verification of the effect of Functional Electrical Stimulation on knee varus thrust aimed to prevent the progression of knee osteoarthritis
Scientific Title:Acronym
FES trial for knee OA
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validate the effect of muscle reeducate training during gait with FES to knee osteoarthritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
severity of knee osteoarthritis (kellgren-lawrence grade) after 24 months
Key secondary outcomes
knee varus thrust, vastus medialis on set time, pain scale, knee function, knee abduct moment, body mass index after 24 months
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
vastus medialis reeducation by Functional Electrical Stimulator on walking exercise done on once to three times weekly for 6 months followed.
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
kellgren-lawrence grade 1-3
out patient
written informed consent
without dementia
Key exclusion criteria
have disease on the other joints
cannot walk 10m
risk of fall (a score of 10 or above)
deemed inappropriate for this study by doctor
using cardiac pacemakers and other implantable medical electrical devices and metal implants
history or suspected epilepsy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kai |
| Middle name | |
| Last name | Ushio |
Organization
Hiroshima University Hospital
Division name
Department of Rehabilitation
Zip code
734-8551
Address
1-2-3 kasumi, minami-ku, hiroshima, hiroshima
TEL
082-257-5566
ushiosista@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Noboru |
| Middle name | |
| Last name | Shimada |
Organization
Hiroshima University Hospital
Division name
Division of clinical support
Zip code
734-8551
Address
1-2-3 kasumi, minami-ku, hiroshima, hiroshima
TEL
082-257-5566
Homepage URL
nshimada@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Hiroshima University Certified Review Board
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, Japan
Tel
082-257-1551
iryo-seisaku@office.hiroshima-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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 01 | 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
| 2019 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2023 | 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
| 2019 | Year | 01 | Month | 18 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040548
