The Effect of an App-based Physiotherapeutic Exercise Regimen on Early Postoperative Compliance for Patients Undergoing Total Knee Arthroplasty, Protocol of A Randomized Control Trial

Background: Physical therapy is an important factor determining the outcome of total knee arthroplasty. According to many studies, half of the patients are not active enough to maintain their physical health after total knee replacement. In our randomised controlled study, we are going to determine the effect of a mobile reminder application on compliance of the subjects with their prescribed physiotherapeutic exercises. Methods: : The trial will be monocentric and take place at the University Hospital Brandenburg/Havel. The participants will have undergone total knee replacement and be aged between 55 and 80 years. Recruitment will happen two weeks prior to surgery when the indication for elective total knee replacement will be determined. After randomization, the patients will be divided into two groups. One group will receive the physiotherapeutic exercise app while the other group will receive the same exercises in paper form and be instructed orally on when to complete the exercises. For the purpose of objectively analysing the compliance of patients, a knee sensor device will be used to track down the varying movements of the knee. Data regarding the outcome of the surgery like patient related outcome measures and performance based measures will be recorded. The hypothesis of the study is that app based inpatient physical therapy leads to higher compliance than a paper-based approach. A non-compliance questionnaire will be translated from English and given to the patients to uncover the motivation behind their non-adherence to their programmes. The analyst working with the knee sensors, the physicians measuring the outcome as well as the patients will be blinded. Between group differences will be analysed with t-test or non-parametric test according to distribution of results. Discussion: The collected data that will be included in our results encompass the digital data of the sensors, the PROMs, the PBMs and the non-compliance questionnaire. It is assumed that patients having the reminder app will have a higher rate of compliance than the control group. The secondary objectives of this study might include the link between the rate of compliance and the outcome after surgery. Another secondary outcome might be the contrast between the actual compliance reported by the sensors and the patient reported compliance and new insides into sensor based monitoring are going to be collected in an exploratory way. Trial registration: The trial was registered at the Deutsches Register Für Klinische Studien. (DRKS)