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

This study is currently recruiting participants.
Verified March 2012 by University of Michigan
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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
History of Changes
  Purpose

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.


Condition Intervention
Anterior Cruciate Ligament Injury
 Other: Neuromuscular Electrical Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: August 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Other: Neuromuscular Electrical Stimulation
NMES will be delivered 3 times per week
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.
 Other: Neuromuscular Electrical Stimulation
NMES will be delivered 3 times per week
No Intervention: No NMES
This group will undergo standard ACL rehabilitation without the addition of NMES

  Eligibility

Ages Eligible for Study:   14 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555567

Contacts
Contact: Riann Palmieri-Smith, PhD 7346153154 riannp@umich.edu

Locations
United States, Michigan
MedSport Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Riann Palmieri-Smith, PhD     734-615-3154     riannp@umich.edu    
Sponsors and Collaborators
University of Michigan
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  More Information

No publications provided

Responsible Party: Riann Palmieri-Smith, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01555567     History of Changes
Other Study ID Numbers: ACLNMES, 1K08AR053152-01A2
Study First Received: March 6, 2012
Last Updated: March 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
ACL
muscle
quadriceps
strength

ClinicalTrials.gov processed this record on June 17, 2013