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
  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. 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.


Condition Intervention
Anterior Cruciate Ligament Injury
Other: Neuromuscular Electrical Stimulation
Other: Eccentric Exercise

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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 ]

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: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Neuromuscular Electrical Stimulation
NMES will be delivered 2 times per week
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.
Other: Neuromuscular Electrical Stimulation
NMES will be delivered 2 times per week
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.
Other: Eccentric Exercise
Eccentric Exercise will be delivered 2 times per week
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.
Other: Neuromuscular Electrical Stimulation
NMES will be delivered 2 times per week
Other: Eccentric Exercise
Eccentric Exercise will be delivered 2 times per week

  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
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: 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
  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: May 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
ACL
muscle
quadriceps
strength

ClinicalTrials.gov processed this record on October 23, 2014