N/A
N=43
Electrical Stimulation and Eccentric Exercise for Anterior Cruciate Ligament (ACL) Injury
Anterior Cruciate Ligament Injury
Bottom Line
View on ClinicalTrials.gov: NCT01555567 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Quadriceps Strength — 2.1; 2.1; 2.8; 2.9 Nm/kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electrical Stimulation (Device); Eccentric Exercise (Other)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quadriceps Strength |
2.1; 2.1; 2.8; 2.9 | — |
| SECONDARY Central Activation Ratio |
91.8; 91.8; 98.1; 97.6 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01555567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.