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

This study has been completed.

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: May 13, 2015

Last verified: May 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

March 6, 2012

Last Updated Date

May 13, 2015

Start Date ^ICMJE

August 2009

Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Quadriceps Strength [ Time Frame: Time of return to activity (~6 months following surgery) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT01555567 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Central Activation Ratio [ Time Frame: Time of return to activity (~6 months following surgery) ] [ Designated as safety issue: No ]

CAR = maximal voluntary isometric contractions force / maximal voluntary isometric contractions force + stimulated force

Original Secondary Outcome Measures ^ICMJE

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 ]

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 Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

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

Enrollment ^ICMJE

Completion Date

July 2014

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

Gender

Both

Ages

14 Years to 35 Years (Child, Adult)

Accepts Healthy Volunteers

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

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

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

Information Provided By

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

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