UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018494
Receipt number R000021405
Scientific Title Effects of postoperative neuromuscular erectrical stimulation on quadriceps strength in ACL reconstruction
Date of disclosure of the study information 2015/08/01
Last modified on 2015/07/30 17:13:26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effects of postoperative neuromuscular erectrical stimulation on quadriceps strength in ACL reconstruction

Acronym

Effects of postoperative neuromuscular erectrical stimulation on quadriceps strength in ACL reconstruction

Scientific Title

Effects of postoperative neuromuscular erectrical stimulation on quadriceps strength in ACL reconstruction

Scientific Title:Acronym

Effects of postoperative neuromuscular erectrical stimulation on quadriceps strength in ACL reconstruction

Region

Japan


Condition

Condition

rupture of anterior cruciate ligament

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To certificate that neuromuscular electrical stimulation improve recovery of quadriceps muscle strength in patients undergoing ACL reconstruction.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Measurement of muscle strength in 3,5months afeter operation

Key secondary outcomes



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



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Beginning on the third or fourth day postoperatively,the stimulater is used for 20 minute session per day, over than 3 days per week.
In 2 weeks after operation, it is used over than 2 days per week,to 5months after operation.

Interventions/Control_2

regular treatment, rehabilitation

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

18 years-old <=

Age-upper limit

40 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients between the ages of 18 and 40 years
Can get exercise over than 3times per week
Can come to hospital for rehabilitation over than 2 times after leaving hospital

Key exclusion criteria

Inflammatory arthritis ,implanted pacemakers or defibrillators,dermatological conditions of thigh

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Saito Yoshihiko

Organization

Kitasato University Kitasato Institute Hospital

Division name

Orthopaedics

Zip code


Address

5-9-1 Shirokane,MInato-ku,Tokyo 108-8642

TEL

03-3444-6161

Email

saito-y@insti.kitasato-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Saito Yoshihiko

Organization

Kitasato University Kitasato Institute Hospital

Division name

Orthopaedics

Zip code


Address

5-9-1 Shirokane,MInato-ku,Tokyo 108-8642

TEL

03-3444-6161

Homepage URL


Email

saito-y@insti.kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato University Kitasato Institute Hospital

Institute

Department

Personal name



Funding Source

Organization

SHILAC JAPAN

Organization

Division

Category of Funding Organization

Profit organization

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

2015 Year 08 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

Preinitiation

Date of protocol fixation

2015 Year 08 Month 04 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 10 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

2015 Year 07 Month 30 Day

Last modified on

2015 Year 07 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021405


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name