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

Tracking Information
First Submitted Date ICMJE	March 6, 2012
First Posted Date ICMJE	March 15, 2012
Results First Submitted Date	April 26, 2015
Results First Posted Date	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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	14 Years to 35 Years (Child, Adult)
Accepts Healthy Volunteers	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	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