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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Taiwan University Hospital
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

January 6, 2011
May 27, 2014
January 2011
September 2014   (final data collection date for primary outcome measure)
Muscle activation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01273649 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Therapeutic Effects of Cryotherapy on Arthrogenic Muscle Inhibition in Patients With Cruciate Ligament Reconstruction
Therapeutic Effects of Cryotherapy and Transcutaneous Nerves Stimulation on Arthrogenic Muscle Inhibition in Patients With Anterior Cruciate Ligament Reconstruction

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.

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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anterior Cruciate Ligament Injury
Device: cryotherapy
cryotherapy is given with other physical training
Experimental: ice, rate of force development
to monitor the long term effect of cryotherapy in rate of force development.
Intervention: Device: cryotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2014
September 2014   (final data collection date for primary outcome measure)

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
Male
20 Years to 40 Years
No
Contact: HK Wang, PhD hkwang@ntu.edu.tw
Taiwan
 
NCT01273649
201007065R
Yes
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: HK Wang, PhD National Taiwan University Hospital
National Taiwan University Hospital
May 2014

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