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

Quadriceps Inhibition After ACL Injury: Neuromuscular and Functional Consequences

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01555567
Enrollment
43
Registered
2012-03-15
Start date
2009-08-31
Completion date
2014-07-31
Last updated
2015-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injury

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

DEVICEElectrical Stimulation

Electrical stimulation will be delivered 2 times per week

OTHEREccentric Exercise

Eccentric Exercise will be delivered 2 times per week

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
University of Michigan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 35 Years
Healthy volunteers
No

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

MeasureTime frame
Quadriceps StrengthTime of return to activity (~6 months following surgery)

Secondary

MeasureTime frameDescription
Central Activation RatioTime 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

ArmCount
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
Total36

Baseline characteristics

CharacteristicNeuromuscular Electrical StimulationStandard of CareEccentric ExerciseCombination of NMES and Eccentric ExerciseTotal
Age, Continuous21.8 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
Height1.76 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
Mass81.65 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 Strength2.6 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 participants10 participants8 participants8 participants36 participants
Sex: Female, Male
Female
2 Participants5 Participants3 Participants3 Participants13 Participants
Sex: Female, Male
Male
8 Participants5 Participants5 Participants5 Participants23 Participants

Adverse events

Event typeEG000
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 / 100 / 100 / 80 / 8
serious
Total, serious adverse events
0 / 100 / 100 / 80 / 8

Outcome results

Primary

Quadriceps Strength

Time frame: Time of return to activity (~6 months following surgery)

ArmMeasureValue (MEAN)Dispersion
Neuromuscular Electrical StimulationQuadriceps Strength2.1 Nm/kgStandard Deviation 0.6
Standard of CareQuadriceps Strength2.1 Nm/kgStandard Deviation 0.6
Eccentric ExerciseQuadriceps Strength2.8 Nm/kgStandard Deviation 0.9
Combination of NMES and Eccentric ExerciseQuadriceps Strength2.9 Nm/kgStandard Deviation 0.6
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
Neuromuscular Electrical StimulationCentral Activation Ratio91.8 ratioStandard Deviation 4.6
Standard of CareCentral Activation Ratio91.8 ratioStandard Deviation 9
Eccentric ExerciseCentral Activation Ratio98.1 ratioStandard Deviation 1.2
Combination of NMES and Eccentric ExerciseCentral Activation Ratio97.6 ratioStandard Deviation 2.8

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026