Therapeutic Effects of Cryotherapy on Arthrogenic Muscle Inhibition in Patients With Cruciate Ligament Reconstruction

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified May 2014 by National Taiwan University Hospital.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT01273649

First received: January 6, 2011

Last updated: May 27, 2014

Last verified: May 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

January 6, 2011

Last Updated Date

May 27, 2014

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

September 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Muscle activation [ Time Frame: 6 months ]

To provide information of individual muscles for the correlation analyses, parameters of muscle activation, such as the integrated electromyography (EMG) normalized to the maximal M wave, are favored.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01273649 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Therapeutic Effects of Cryotherapy on Arthrogenic Muscle Inhibition in Patients With Cruciate Ligament Reconstruction

Official Title ^ICMJE

Therapeutic Effects of Cryotherapy and Transcutaneous Nerves Stimulation on Arthrogenic Muscle Inhibition in Patients With Anterior Cruciate Ligament Reconstruction

Brief Summary

Anterior cruciate ligament(ACL) injury is one of the most common sport injuries. The major problem after ACL reconstruction or rehabilitation program is quadriceps weakness. Previous studies suggested that cryotherapy and transcutaneous electrical nerve stimulation(TENS) can effectively reduce the arthrogenic muscle inhibition caused by experimental swelling.

Objective:

To exam the effects of 12 weeks cryotherapy and TENS on arthrogenic muscle inhibition in subjects with ACL reconstruction.

Design:

Prospective study.

Subjects:

Male subjects with isolated ACL injury, age between 18~40 years old are going to receive an ACL reconstruction surgery.

Methods:

Quadriceps activation level, quadriceps peak torque during maximal voluntary contraction and rate of force development are measure at presurgery, 3-month, 6-month after surgery. After surgery, subjects will receive 12 weeks, 3 days/week, training programs included 20 minutes cryotherapy and exercise training with TENS.

Data analysis:

Data will be analyzed using SPSS 13.0 software (SPSS Inc., Chicago, IL). One-way ANOVA will be used to analysis data.

Detailed Description

Examination procedure:

Skin preparation and EMG setting.
Fill out knee joint function questionnaire.
Warmup with a stationary bike.
Single hop for distance.
MVIC test and EMG recording.
Endurance test.
Record surface EMG of vastus lateralis, vastus medialis, biceps femoris and semitendinosus during maximal voluntary contraction.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Anterior Cruciate Ligament Injury

Intervention ^ICMJE

Device: cryotherapy

cryotherapy is given with other physical training

Study Arms

Experimental: ice, rate of force development

to monitor the long term effect of cryotherapy in rate of force development.

Intervention: Device: cryotherapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2014

Estimated Primary Completion Date

September 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male subjects with isolated ACL injury, age between 18~40 years old are going to receive an ACL reconstruction surgery.

Exclusion Criteria:

meniscus lesion, bony fracture and osteochondral lesions

Sex/Gender

Sexes Eligible for Study:

Male

Ages

20 Years to 40 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Taiwan

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01273649

Other Study ID Numbers ^ICMJE

201007065R

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

National Taiwan University Hospital

Study Sponsor ^ICMJE

National Taiwan University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

HK Wang, PhD

National Taiwan University Hospital

PRS Account

National Taiwan University Hospital

Verification Date

May 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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