UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031278
Receipt number R000035697
Scientific Title Effect of early neuromuscular electrical stimulation on quadriceps muscle after total knee Arthroplasty.
Date of disclosure of the study information 2018/03/01
Last modified on 2018/02/13 17:26:54

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Basic information

Public title

Effect of early neuromuscular electrical stimulation on quadriceps muscle after total knee Arthroplasty.

Acronym

Effect of early NMES on quadriceps muscle after TKA

Scientific Title

Effect of early neuromuscular electrical stimulation on quadriceps muscle after total knee Arthroplasty.

Scientific Title:Acronym

Effect of early NMES on quadriceps muscle after TKA

Region

Japan


Condition

Condition

Osteoarthritis of the knee

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examine the effect of neuromuscular electrical stimulation on the quadriceps muscle performed from 2 days after total replacement surgery until 2 weeks after total knee replacement surgery

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Quadriceps muscle strength

Key secondary outcomes

Resting pain, quadriceps maximal contraction pain, knee flexion movement range, knee joint extension range, quadriceps muscle cross sectional area (and IMAT), patellar upper extreme level circumference, patellar superior proximal level circumference Diameter, TUG, SCT


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Neuromuscular electrical stimulation to the quadriceps femoris(Ten times in total for 30 minutes, between 2 days and 14 days after surgery)

Interventions/Control_2

Non-intervention

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

60 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients scheduled to undergo total knee arthroplasty for osteoarthritis

Key exclusion criteria

patients with bilateral TKA, patients with orthopedic disease with strong pain on the other side, patients with infection, neurological symptoms (paralysis of lower limbs etc.) Patients with dementia, skin hyperresponsiveness or skin trouble

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Hisano

Organization

Shiraniwa hospital

Division name

Department of Rehabilitation

Zip code


Address

6-10-1, Shiraniwadai, Ikoma-shi, Nara, 630-0136, Japan

TEL

0743-70-0022

Email

takashi807@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Hisano

Organization

Elixir

Division name

Nursing home care

Zip code


Address

4137, Kamimachi, Ikoma-shi, Nara, 630-0131, Japan

TEL

0743-70-0070

Homepage URL


Email

takashi807@gmail.com


Sponsor or person

Institute

Department of Rehabilitation Shiraniwa hospital

Institute

Department

Personal name



Funding Source

Organization

Shiraniwa 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


Address


Tel


Email



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

医療法人社団松下会 白庭病院


Other administrative information

Date of disclosure of the study information

2018 Year 03 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

2017 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 01 Month 14 Day

Last follow-up date

2018 Year 10 Month 31 Day

Date of closure to data entry

2018 Year 12 Month 31 Day

Date trial data considered complete

2018 Year 12 Month 31 Day

Date analysis concluded

2019 Year 02 Month 28 Day


Other

Other related information



Management information

Registered date

2018 Year 02 Month 13 Day

Last modified on

2018 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035697


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name