Anterior Cruciate Ligament Injury
Conditions
Keywords
ACL, muscle, quadriceps, strength
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.
Interventions
Electrical stimulation will be delivered 2 times per week
Eccentric Exercise will be delivered 2 times per week
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quadriceps Strength | Time of return to activity (~6 months following surgery) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Activation Ratio | Time of return to activity (~6 months following surgery) | CAR = maximal voluntary isometric contractions force / maximal voluntary isometric contractions force + stimulated force |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Neuromuscular Electrical Stimulation Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.
Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week | 10 |
| Standard of Care This group will undergo standard ACL rehabilitation | 10 |
| 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.
Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week | 8 |
| Combination of NMES and Eccentric Exercise Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES 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.
Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week
Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week | 8 |
| Total | 36 |
Baseline characteristics
| Characteristic | Neuromuscular Electrical Stimulation | Standard of Care | Eccentric Exercise | Combination of NMES and Eccentric Exercise | Total |
|---|---|---|---|---|---|
| Age, Continuous | 21.8 years STANDARD_DEVIATION 4.4 | 18.3 years STANDARD_DEVIATION 3.7 | 23.2 years STANDARD_DEVIATION 5.4 | 23.2 years STANDARD_DEVIATION 6.3 | 21.6 years STANDARD_DEVIATION 4.9 |
| Central Activation Ratio (CAR) | 97.4 ratio STANDARD_DEVIATION 3 | 94.9 ratio STANDARD_DEVIATION 5.3 | 95.9 ratio STANDARD_DEVIATION 4.5 | 95.7 ratio STANDARD_DEVIATION 3.5 | 95.9 ratio STANDARD_DEVIATION 4.1 |
| Height | 1.76 meter STANDARD_DEVIATION 0.1 | 1.73 meter STANDARD_DEVIATION 0.1 | 1.75 meter STANDARD_DEVIATION 0.1 | 1.45 meter STANDARD_DEVIATION 0.6 | 1.67 meter STANDARD_DEVIATION 0.22 |
| Mass | 81.65 kg STANDARD_DEVIATION 22.6 | 75.5 kg STANDARD_DEVIATION 24.1 | 77.7 kg STANDARD_DEVIATION 10.4 | 77.8 kg STANDARD_DEVIATION 16.5 | 78.2 kg STANDARD_DEVIATION 18.4 |
| Quadriceps Strength | 2.6 Nm/kg STANDARD_DEVIATION 0.6 | 2.6 Nm/kg STANDARD_DEVIATION 0.6 | 2.8 Nm/kg STANDARD_DEVIATION 1.1 | 2.7 Nm/kg STANDARD_DEVIATION 0.8 | 2.67 Nm/kg STANDARD_DEVIATION 0.78 |
| Region of Enrollment United States | 10 participants | 10 participants | 8 participants | 8 participants | 36 participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants | 3 Participants | 13 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 5 Participants | 5 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 8 | 0 / 8 |
Outcome results
Quadriceps Strength
Time frame: Time of return to activity (~6 months following surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Electrical Stimulation | Quadriceps Strength | 2.1 Nm/kg | Standard Deviation 0.6 |
| Standard of Care | Quadriceps Strength | 2.1 Nm/kg | Standard Deviation 0.6 |
| Eccentric Exercise | Quadriceps Strength | 2.8 Nm/kg | Standard Deviation 0.9 |
| Combination of NMES and Eccentric Exercise | Quadriceps Strength | 2.9 Nm/kg | Standard Deviation 0.6 |
Central Activation Ratio
CAR = maximal voluntary isometric contractions force / maximal voluntary isometric contractions force + stimulated force
Time frame: Time of return to activity (~6 months following surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Electrical Stimulation | Central Activation Ratio | 91.8 ratio | Standard Deviation 4.6 |
| Standard of Care | Central Activation Ratio | 91.8 ratio | Standard Deviation 9 |
| Eccentric Exercise | Central Activation Ratio | 98.1 ratio | Standard Deviation 1.2 |
| Combination of NMES and Eccentric Exercise | Central Activation Ratio | 97.6 ratio | Standard Deviation 2.8 |