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 2022/07/22 20:17:30

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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

Email

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


Email

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

Email

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

Enrolling by invitation

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

2022 Year 07 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040548


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name