Adherence to Post-operative Treatment Clinical Trial
Official title:
Effects of a Superimposed Electrical Stimulation Knee Garment on Strength, Function, Inhibition, Cortical Excitability, and Patient Reported Outcomes After Knee Surgery
The purpose of this study is to determine if a home-based electrical stimulation (ES) program is more effective than the standard of care (SOC) at improving quadriceps function, functional outcomes, patient reported outcomes, and treatment compliance in patients recovering from knee surgery. It is hypothesized that there will be significantly better outcomes and compliance in ES group when compared to the SOC group.
The purpose of this study is to evaluate the effect of home-based neuromuscular electrical
stimulation applied via a knee sleeve on strength, function, inhibition, and patient reported
outcomes. Strength will be evaluated via isometric knee extension, neuromuscular inhibition
will be assessed via a superimposed burst technique, and cortical excitability will be
assessed via transcranial magnetic stimulation. In addition, we will evaluate function
through a single-leg hop task, star excursion balance test, and a step down task. Patient
reported outcomes will be assessed via the: Veterans Rand 12 Item Health Survey (VR-12), Knee
Osteoarthritis Outcomes Score (KOOS), the International Cartilage Repair Society (ICRS), the
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, and the
Lysholm scale.
Once a participant is identified as eligible and consents to enroll in the study, they will
be allocated to either an intervention or control group. The participants in the intervention
group will receive a knee sleeve that has a neuromuscular ES unit embedded into the garment
(EMPI Phoenix, DJO Global, Vista, California) in addition to SOC. A superimposed electrical
signal (maximal toleration) will be utilized during treatment in order to successfully
overload the muscle. During the electrical stimulation the participants will be instructed to
perform an isometric contraction and hold this contraction through the length of the
stimulation. Beginning one week post-operatively the participants will be instructed to
perform NMES treatment 3 times a day for 20 minutes 5 times a week for 12 weeks. The
stimulation will be delivered at a frequency of 75Hz with a duty cycle of 4 seconds on and 10
seconds off. The control group will be treated with the current SOC, performing a home-based
treatment of volitional isometrics contractions without the addition of neuromuscular
electrical stimulation beginning on the third day post-operatively. Participants will perform
20 isometric contractions holding each contraction for 10 seconds 3 times a day 5 times a
week for 12 weeks. Participants will be instructed to keep a treatment log documenting at
each session how many exercises and at what intensity they performed.
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