Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Virginia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00971451
First received: September 2, 2009
Last updated: March 4, 2011
Last verified: March 2011
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quadriceps H-reflex testing [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • International Knee Documentation Committee Subjective Knee Joint Evaluation [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Visual Analog Scale [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Tegner Activity Rating [ Time Frame: Day 15 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971451

Contacts
Contact: Joseph M Hart, Ph.D. 434-243-0256 jmh3zf@hscmail.mcc.virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Joseph M Hart, PhD    434-243-0256    jmh3zf@virginia.edu   
Principal Investigator: Joseph M Hart, Ph.D.         
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Joseph M Hart, Ph.D. University of Virginia
  More Information

No publications provided

Responsible Party: Joseph M. Hart, Ph.D., Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT00971451     History of Changes
Other Study ID Numbers: 13398
Study First Received: September 2, 2009
Last Updated: March 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Anterior cruciate ligament
ACL

ClinicalTrials.gov processed this record on October 16, 2014