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The current standard for rehabilitation after TKA consists of guided exercise therapy for up to 12 weeks after surgery. This includes inpatient, home, and outpatient therapy. The surgery and rehabilitation are highly successful at reducing or eliminating pain experienced preoperatively. However, quadriceps femoris muscle (QFM) strength, overall function, and knee range of motion are often worse than preoperative levels for as long as 6 months after surgery and in some cases may persist for many years after that. Such quadriceps strength impairments after TKA have been largely attributed to voluntary activation deficits and can lead to a decrease in functional performance such as decreased gait speed, decreased balance which can lead to falls, and decreased stair climbing & chair rise abilities.
Since therapy alone does not adequately restore or improve upon the preoperative functional capabilities in a consistent and timely manner, it has been suggested that NMES used adjunctively with postoperative rehabilitation will alleviate the quadriceps muscle activation deficits. Early NMES use after TKA has been shown to: reduce knee extensor lag, increase walking speed, and improve QFM strength, knee range of motion, and function. However, NMES initiated one month after TKA did not lead to improved QFM strength or function beyond the standard benefits gained from exercise alone, thus suggesting that the timing of NMES application after TKA is important.
It has previously been shown that preoperative QFM strength is predictive of postoperative function [6] but the benefit of prehabilitation remains in question. To date, there has only been one pilot study assessing the benefits of NMES when initiated preoperatively. This study only included 14 patients (9 NMES, 5 control) but was able to show that preoperative NMES usage may lead to greater QFM strength gains after TKA. Therefore, it will be important to assess the benefits of NMES both preoperatively and postoperatively in order to determine how it will be most beneficial to TKA patients.
Full description
The study duration will be until 12 weeks ± 1 week postoperatively. Data will be collected (1) 4 weeks preoperatively, (2) prior to hospital admission for TKA, and (3) at 3, 6, and 12 weeks postoperatively. The research coordinator at the site will identify, recruit, and prospectively follow the 66 patients at his/her site.
All data will be entered and maintained in REDCap, an electronic data capture tools hosted at Cleveland Clinic. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. Only members of the study team (i.e. the personnel listed on the institutional review board (IRB) application) will have access to protected health information of patients included in this study.
Pretreatment Assessments
Before treatment, the following assessments/tests will be performed and the results will be recorded on the appropriate pages of the (case report form) CRF, and or Microsoft excel, Microsoft Word, and REDCap:
Presurgery Assessments
Before surgery, the following assessments/tests will be performed and the results will be recorded on the appropriate pages of the CRF, and or Microsoft excel, Microsoft Word, and REDCap:
Operative Assessments
The following will be collected from the Operative and Anesthesia Records and recorded on the appropriate pages of the CRF, and or Microsoft excel, Microsoft Word, and REDCap:
Postoperative Assessments After surgery, one or more of the following will be collected through the online app and at follow-up visits.
As a last resort, if a patient is unable to keep one of these appointments, he/she will be either be mailed or emailed the patient reported outcome forms so the patient can fill them out. The patient will date and time the forms. Participants will then send the form back in a pre-addressed envelope. The patients email will be verified by the patient during a clinical visit to ensure accuracy of the correct recipient. Patients not responding to the initial mailer will be contacted by phone and forms may be administered over the phone. The mailers and/or phone calls will allow us to collect all data except the physical function measures.
All data will be entered and maintained in Redcap
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66 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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