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Electrical Stimulation and Eccentric Exercise for Anterior Cruciate Ligament (ACL) Injury

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ClinicalTrials.gov Identifier: NCT01555567
Recruitment Status : Completed
First Posted : March 15, 2012
Results First Posted : May 14, 2015
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Riann Palmieri-Smith, University of Michigan

Tracking Information
First Submitted Date  ICMJE March 6, 2012
First Posted Date  ICMJE March 15, 2012
Results First Submitted Date  ICMJE April 26, 2015
Results First Posted Date  ICMJE May 14, 2015
Last Update Posted Date June 8, 2015
Study Start Date  ICMJE August 2009
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2015)
Quadriceps Strength [ Time Frame: Time of return to activity (~6 months following surgery) ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2012)
  • Quadriceps Strength [ Time Frame: Change from Baseline at 10 weeks post-operatively, Change from Baseline at 6 months post-operatively ]
  • Quadriceps activation [ Time Frame: Change from Baseline at 10 weeks post-operatively, Change from Baseline at 6 months post-operatively ]
Change History Complete list of historical versions of study NCT01555567 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2015)
Central Activation Ratio [ Time Frame: Time of return to activity (~6 months following surgery) ]
CAR = maximal voluntary isometric contractions force / maximal voluntary isometric contractions force + stimulated force
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2012)
  • Knee flexor moment [ Time Frame: Change from Baseline at 10 weeks post-operatively, Change from Baseline at 6 months post-operatively ]
  • KOOS scale [ Time Frame: Change from Baseline at 10 weeks post-operatively, Change from Baseline at 6 months post-operatively ]
  • Hop for distance [ Time Frame: Change from Baseline at 10 weeks post-operatively, Change from Baseline at 6 months post-operatively ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electrical Stimulation and Eccentric Exercise for Anterior Cruciate Ligament (ACL) Injury
Official Title  ICMJE Quadriceps Inhibition After ACL Injury: Neuromuscular and Functional Consequences
Brief Summary 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.
Detailed Description Neuromuscular electrical stimulation (NMES) has been shown to reduce quadriceps activation failure (QAF) and eccentric exercise has been shown to lessen muscle atrophy post-ACL reconstruction. Given thatthese are two critical components of quadriceps strength, intervention combining these therapies may be effective at reinstituting quadriceps function post-reconstruction. Therefore, the aim of this study is to evaluate the effectiveness of a combined NMES and eccentric exercise intervention to improve the recovery of quadriceps activation and strength post-reconstruction. Patients post ACL-injury will be placed into four treatment groups (NMES and eccentrics; eccentrics only; NMES only, and standard of care) Patients assigned to the NMES and eccentric and the NMES only groups will receive the NMES protocol 2× per week for the first 6 weeks post-reconstruction. MES and eccentric and the eccentrics only groups will receive the eccentric exercise protocol 2× perweek beginning 6 weeks post-reconstruction. Quadriceps activation was assessed via the superimposed burst technique and quantified via the central activation ratio.Quadriceps strength was assessed via maximal voluntary isomeric contractions (Nm/kg). Data will be gathered on three occasions: pre-operative, 12-weeks-post-surgery and at return-to-play.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anterior Cruciate Ligament Injury
Intervention  ICMJE
  • Device: Electrical Stimulation
    Electrical stimulation will be delivered 2 times per week
  • Other: Eccentric Exercise
    Eccentric Exercise will be delivered 2 times per week
Study Arms  ICMJE
  • Experimental: Electrical stimulation
    Subjects placed into this group will undergo electrical stimulation following anterior cruciate ligament reconstruction (ACLr). Subjects will be required to report 2 times per week for 6 weeks following ACLr for electrical stimulation therapy. Electrical stimulation therapy post-reconstruction will commence immediately post-ACLr and end at week 6.
    Intervention: Device: Electrical Stimulation
  • No Intervention: Standard of Care
    This group will undergo standard ACL rehabilitation
  • Experimental: Eccentric Exercise
    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: Stimulation and Eccentrics
    Subjects placed into this group will undergo a combined electrical stimulation and eccentric exercise intervention following ACLr. The electrical stimulation intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the electrical stimulation 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:
    • Device: Electrical Stimulation
    • Other: Eccentric Exercise
Publications * Lepley LK, Palmieri-Smith RM. Quadriceps Strength, Muscle Activation Failure, and Patient-Reported Function at the Time of Return to Activity in Patients Following Anterior Cruciate Ligament Reconstruction: A Cross-sectional Study. J Orthop Sports Phys Ther. 2015 Dec;45(12):1017-25. doi: 10.2519/jospt.2015.5753. Epub 2015 Oct 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2015)
43
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2012)
30
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01555567
Other Study ID Numbers  ICMJE ACLNMES
1K08AR053152-01A2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Riann Palmieri-Smith, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE
Principal Investigator: Riann M Palmieri-Smith, PhD University of Michigan
PRS Account University of Michigan
Verification Date May 2015

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