DIGITAL THERAPEUTICS FOR KNEE JOINT RECOVERY AFTER TOTAL KNEE REPLACEMENT SURGERY: A RELIABILITY AND VALIDITY STUDY

Abstract

Background/Objectives: Digital Therapeutics (DTx) is an evidence-based behavioral therapy provided online through software and other means, which can enhance the accessibility and efficiency of healthcare for the prevention, management, and treatment of medical disorders or diseases. This study aims to verify the clinical effectiveness of an app-based digital therapeutic linked with a device developed to extend treatment sessions at home after Total Knee Replacement (TKR) surgery and to facilitate from early rehabilitation to subsequent stages. The objective is also to confirm the reliability and validity between Range of Motion (ROM) measurements conducted by traditional therapists and those measured by DDA. Methods/Statistical analysis: This study was conducted according to the Guidelines for Reporting Reliability and Agreement Studies (GRRAS), with a total of 20 participants involved. All participants voluntarily participated in the study based on selection criteria, and after receiving approval from the Institutional Review Board (IRB), they were pre-registered in clinical research information service (CRIS). Joint angles for knee flexion were measured twice each using a developed digital therapeutic apparatus by two experienced physical therapists and a goniometer. Intra-class correlation coefficients were used to calculate intra-rater reliability and inter-rater reliability, while validity was calculated through Pearson correlation. All statistical significance levels were set at 0.05. Findings: Intra-rater reliability was excellent for the DDA (ICC>0.90), with a statistically significant difference (p=0.000), and excellent (ICC>0.90) and good reliability (ICC=0.86) for the goniometer, with a statistically significant difference (p=0.000). Inter-rater reliability was good for almost all measures (ICC>0.80) and excellent for the goniometer pre-measurement (ICC>0.90), all with statistically significant differences (p=0.000). The validity of the two instruments showed a strong positive correlation (r=0.75) with a statistically significant difference (p=0.000). Improvements/Applications: In this study, the DDA ultimately showed reliability and validity as good as the goniometer used by conventional physical therapists to measure joint angles and can be used to measure knee joint angles.