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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01273649
Recruitment Status : Unknown
Verified May 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : January 10, 2011
Last Update Posted : May 29, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE January 6, 2011
First Posted Date  ICMJE January 10, 2011
Last Update Posted Date May 29, 2014
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2011)
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
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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:

  1. Skin preparation and EMG setting.
  2. Fill out knee joint function questionnaire.
  3. Warmup with a stationary bike.
  4. Single hop for distance.
  5. MVIC test and EMG recording.
  6. Endurance test.
  7. Record surface EMG of vastus lateralis, vastus medialis, biceps femoris and semitendinosus during maximal voluntary contraction.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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  ICMJE 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
 (submitted: January 7, 2011)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE 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  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
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  ICMJE 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