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Quadriceps Function Prior to Anterior 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 March 2011 by University of Virginia.
Recruitment status was:  Recruiting
Information provided by:
University of Virginia Identifier:
First received: September 2, 2009
Last updated: March 4, 2011
Last verified: March 2011

Patients who are diagnosed with an isolated tear of the anterior cruciate ligament and scheduled for arthroscopic reconstruction using bone-patellar tendon-bone autograft will be recruited to participate.

All subjects will be invited to participate in 2 weeks (2 supervised sessions per week) prior to their surgery. Each session will include supervised therapeutic exercises. Subjects will be randomly assigned to receive continuous transcutaneous electrical nerve stimulation (TENS) during each session or knee joint cryotherapy prior to each exercise session. The investigators will measure quadriceps function before and after this 2-week intervention (both sessions occur prior to reconstruction surgery). This study will also have a true control group that will not receive either exercise of modality intervention. The investigators will collect subjective and objective outcomes data at regularly scheduled post-operative visits.

Condition Intervention
Rupture of Anterior Cruciate Ligament
Other: cryotherapy
Other: TENS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction

Resource links provided by NLM:

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Quadriceps muscle strength and inhibition using the quadriceps central activation ratio [ Time Frame: Day 15 ]

Secondary Outcome Measures:
  • Quadriceps H-reflex testing [ Time Frame: Day 15 ]
  • International Knee Documentation Committee Subjective Knee Joint Evaluation [ Time Frame: Day 15 ]
  • Visual Analog Scale [ Time Frame: Day 15 ]
  • Tegner Activity Rating [ Time Frame: Day 15 ]

Estimated Enrollment: 50
Study Start Date: November 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: knee joint cryotherapy
20 minutes of knee joint cryotherapy - ice bag application
Other: cryotherapy
20 minutes of knee joint cryotherapy - ice bag application
Experimental: TENS
continuous TENS for duration of the 1 hour exercise session
Other: TENS
continuous use of TENS during the exercise session
No Intervention: No intervention
no modality intervention; just exercise


Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Complete ACL rupture
  2. Age 15-55

Exclusion Criteria:

  1. Persons who cannot tolerate knee joint TENS.
  2. Persons who have a known allergy to cryotherapy
  3. Patients who are pregnant or who plan on getting pregnant during the 12-month follow-up period.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00971451

Contact: Joseph M Hart, Ph.D. 434-243-0256

United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Joseph M Hart, PhD    434-243-0256   
Principal Investigator: Joseph M Hart, Ph.D.         
Sponsors and Collaborators
University of Virginia
Principal Investigator: Joseph M Hart, Ph.D. University of Virginia
  More Information

Responsible Party: Joseph M. Hart, Ph.D., Assistant Professor, University of Virginia Identifier: NCT00971451     History of Changes
Other Study ID Numbers: 13398
Study First Received: September 2, 2009
Last Updated: March 4, 2011

Keywords provided by University of Virginia:
Anterior cruciate ligament

Additional relevant MeSH terms:
Wounds and Injuries processed this record on May 25, 2017