Pre-operative Electrical Stimulation for Anterior Cruciate Ligament (ACL) Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Riann Palmieri-Smith, University of Michigan
ClinicalTrials.gov Identifier:
NCT01555567
First received: March 6, 2012
Last updated: March 13, 2012
Last verified: March 2012

March 6, 2012
March 13, 2012
August 2009
March 2013   (final data collection date for primary outcome measure)
  • Quadriceps strength [ Time Frame: Change from Baseline at 10 weeks post-operatively, Change from Baseline at 6 months post-operatively ] [ Designated as safety issue: No ]
  • Quadriceps activation [ Time Frame: Change from Baseline at 10 weeks post-operatively, Change from Baseline at 6 months post-operatively ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01555567 on ClinicalTrials.gov Archive Site
  • Knee flexor moment [ Time Frame: Change from Baseline at 10 weeks post-operatively, Change from Baseline at 6 months post-operatively ] [ Designated as safety issue: No ]
  • KOOS scale [ Time Frame: Change from Baseline at 10 weeks post-operatively, Change from Baseline at 6 months post-operatively ] [ Designated as safety issue: No ]
  • Hop for distance [ Time Frame: Change from Baseline at 10 weeks post-operatively, Change from Baseline at 6 months post-operatively ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pre-operative Electrical Stimulation for Anterior Cruciate Ligament (ACL) Injury
Not Provided

Quadriceps muscle weakness is a common consequence of ACL injury. This muscle weakness is considered to result from neural inhibition preventing full muscle contraction and is referred to as arthrogenic muscle inhibition (AMI). AMI hinders rehabilitation by preventing gains in strength, increasing the risk of re-injury, and potentially placing patients at risk for chronic degenerative joint conditions. Interventions that are designed to counter this muscle weakness are much needed in order to promote long-term knee joint health. The purpose fo the current study is to determine the efficacy of neuromuscular electrical stimulation in improving quadriceps muscle function and biomechanics in patients prior to and following ACL reconstruction. The investigators expect that patients who receive electrical stimulation will have better improvement in quadriceps strength and activation. The investigators also hypothesize that these patients will display knee motion similar to uninjured control subjects.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anterior Cruciate Ligament Injury
Other: Neuromuscular Electrical Stimulation
NMES will be delivered 3 times per week
  • Experimental: Neuromuscular electrical stimulation post-operatively
    Subjects randomized to this group will undergo NMES following ACLr. Subjects will be required to report 3 times per week for 4 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence at week 2 and end at week 6.
    Intervention: Other: Neuromuscular Electrical Stimulation
  • Experimental: NMES pre and post ACL reconstruction
    Subjects randomized to this group will undergo NMES prior to ACLr and following ACLr. Subjects will be required to report 3 times per week for 2 weeks prior to ACLr and 3 times per week for 4 weeks following ACLr for NMES therapy.
    Intervention: Other: Neuromuscular Electrical Stimulation
  • No Intervention: No NMES
    This group will undergo standard ACL rehabilitation without the addition of NMES
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 14-35 years
  • Willingness to participate in testing and follow-up as outlined in the protocol
  • Scheduled to undergo ACL reconstruction

Exclusion Criteria:

  • Previous quadriceps injury
  • Inability to provide informed consent
  • Pregnant females
  • ACL injury sustained more than 48 hours prior to reporting to physician
  • ACL injury sustained when not engaged in sports participation (i.e. while engaged in activities of daily living)
  • Previous partial ACL tear
  • Previous surgery to injured knee
  • Total or partial meniscectomy accompanying ACL reconstruction
  • Other ligamentous injury accompanying ACL injury
Both
14 Years to 35 Years
No
Contact: Riann Palmieri-Smith, PhD 7346153154 riannp@umich.edu
United States
 
NCT01555567
ACLNMES, 1K08AR053152-01A2
No
Riann Palmieri-Smith, University of Michigan
University of Michigan
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Not Provided
University of Michigan
March 2012

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