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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Michigan
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Riann Palmieri-Smith, University of Michigan
ClinicalTrials.gov Identifier:
NCT01555567
First received: March 6, 2012
Last updated: May 15, 2014
Last verified: May 2014

March 6, 2012
May 15, 2014
August 2009
July 2014   (final data collection date for primary outcome measure)
  • Quadriceps strength [ Time Frame: Change from Baseline at 12 weeks post-operatively, Change from Baseline at 6 months post-operatively ] [ Designated as safety issue: No ]
  • Quadriceps activation [ Time Frame: Change from Baseline at 12 weeks post-operatively, Change from Baseline at 6 months post-operatively ] [ Designated as safety issue: No ]
  • 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 ]
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. Quadriceps weakness that occurs following ACL injury is also thought to be caused by muscle atrophy which is thought to manifest due to alterations in muscle architecture, selective fiber atrophy or even neural deficits such as AMI. Importantly, interventions that are designed to counter this muscle weakness are required in order to promote long-term knee joint health. Hence, the purpose of the current study is to determine the efficacy of interventions that target quadriceps weakness to improve quadriceps muscle function and biomechanics in patients prior to and following ACL reconstruction. Specifically, the efficacy of neuromuscular electrical stimulation aimed at improving quadriceps neural activity and eccentric exercise intended to minimize quadriceps muscle atrophy will be investigated. The investigators expect that patients who receive the electrical stimulation therapy will demonstrate improvements in quadriceps strength and activation. Furthermore, it is expected that patients who receive both the electrical stimulation and eccentric intervention will demonstrate markedly greater gains in quadriceps strength and activation than patients who receive only the electrical stimulation therapy or standard of care post-surgery. The investigators also hypothesize that the patients who receive the electrical stimulation therapy and/or eccentrics will display knee motion similar to uninjured control subjects.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anterior Cruciate Ligament Injury
  • Other: Neuromuscular Electrical Stimulation
    NMES will be delivered 2 times per week
  • Other: Eccentric Exercise
    Eccentric Exercise will be delivered 2 times per week
  • Experimental: Neuromuscular electrical stimulation post-operatively
    Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.
    Intervention: Other: Neuromuscular Electrical Stimulation
  • Experimental: NMES pre and post ACL reconstruction
    Subjects placed into 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
  • Experimental: Eccentric Exercise post-operatively
    Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.
    Intervention: Other: Eccentric Exercise
  • Experimental: Combination of NMES and Eccentric Exercise post-operatively
    Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.
    Interventions:
    • Other: Neuromuscular Electrical Stimulation
    • Other: Eccentric Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
July 2014
July 2014   (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
May 2014

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