UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025641
Receipt number R000029503
Scientific Title Efficasy of neuromuscle stimulation after anterior cruciate ligament reconstruction
Date of disclosure of the study information 2017/01/31
Last modified on 2017/01/12 14:33:32

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Basic information

Public title

Efficasy of neuromuscle stimulation after anterior cruciate ligament reconstruction

Acronym

Efficasy of neuromuscle stimulation after anterior cruciate ligament reconstruction

Scientific Title

Efficasy of neuromuscle stimulation after anterior cruciate ligament reconstruction

Scientific Title:Acronym

Efficasy of neuromuscle stimulation after anterior cruciate ligament reconstruction

Region

Japan


Condition

Condition

Anterior Cruciate ligament injury

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to assess the efficacy of neuromuscular electrical stimulation after anterior cruciate ligament reconstruction.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

muscle power

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Neuromuscular Electrical Stimulation

Interventions/Control_2

without Neuromuscular Electrical Stimulation

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

13 years-old <=

Age-upper limit

50 years-old >=

Gender

Male and Female

Key inclusion criteria

The patients agreed to undergo ACLR and were able to implement our standard postoperative rehabilitation protocol.

Key exclusion criteria

Exclusion criteria included a history of OA or inflammatory arthritis, earlier surgery to either knee for a previous injury, neuromusclar disease, pacemaker,anesthesia,and allergy patient.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Munehiro Ogawa

Organization

Nara Medical University

Division name

Department of Orthopaedic Surgery

Zip code


Address

840, Shijyo-cho, Kashihara, Nara, 634-8522 Japan

TEL

0744-22-3051

Email

mogawa@naramed-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Munehiro Ogawa

Organization

Nara Medical University

Division name

Department of Orthopaedic Surgery

Zip code


Address

840, Shijyo-cho, Kashihara, Nara, 634-8522 Japan

TEL

0744-22-3051

Homepage URL


Email

mogawa@naramed-u.ac.jp


Sponsor or person

Institute

Nara Medical University

Institute

Department

Personal name



Funding Source

Organization

Nara Medical University

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



Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 31 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

Terminated

Date of protocol fixation

2013 Year 06 Month 04 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 04 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 01 Month 12 Day

Last modified on

2017 Year 01 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029503


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name