- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01555567
Electrical Stimulation and Eccentric Exercise for Anterior Cruciate Ligament (ACL) Injury
May 13, 2015 updated by: Riann Palmieri-Smith, University of Michigan
Quadriceps Inhibition After ACL Injury: Neuromuscular and Functional Consequences
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- MedSport
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 35 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Electrical stimulation will be delivered 2 times per week
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No Intervention: Standard of Care
This group will undergo standard ACL rehabilitation
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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.
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Eccentric Exercise will be delivered 2 times per week
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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.
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Electrical stimulation will be delivered 2 times per week
Eccentric Exercise will be delivered 2 times per week
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quadriceps Strength
Time Frame: Time of return to activity (~6 months following surgery)
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Time of return to activity (~6 months following surgery)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Central Activation Ratio
Time Frame: Time of return to activity (~6 months following surgery)
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CAR = maximal voluntary isometric contractions force / maximal voluntary isometric contractions force + stimulated force
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Time of return to activity (~6 months following surgery)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
March 6, 2012
First Submitted That Met QC Criteria
March 13, 2012
First Posted (Estimate)
March 15, 2012
Study Record Updates
Last Update Posted (Estimate)
June 8, 2015
Last Update Submitted That Met QC Criteria
May 13, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACLNMES
- 1K08AR053152-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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