This study evaluates a wearable plantar-pressure insole system (EUKINES) designed to support gait training during postoperative rehabilitation after primary total hip arthroplasty (THA). The trial will include 200 adults who are randomly assigned to one of four rehabilitation programs: EUKINES with real-time biofeedback, EUKINES without biofeedback, a certified commercial reference system with biofeedback, or standard rehabilitation without any gait-analysis device. All participants will receive a structured 6-week rehabilitation program after THA, and the only differences between groups concern the use of gait-analysis technology and biofeedback. The main outcomes include changes in plantar-pressure-based gait parameters (mean foot pressure and load asymmetry) and standard clinical scores of hip function and symptoms. The study will also monitor safety, device-related events, walking speed, pain, and patient and therapist ratings of usability and satisfaction. The goal is to determine whether rehabilitation supported by the EUKINES insole system is at least as effective and safe as rehabilitation supported by a certified reference system and as standard care, and to explore the feasibility of using low-cost, printed-sensor technology for routine gait assessment and future telerehabilitation.
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Change in mean foot pressure (MFP) on the operated limb
Timeframe: Baseline (Week 0), Week 3, Week 6 after surgery
Change in load asymmetry between operated and non-operated limb
Timeframe: Baseline (Week 0), Week 3, Week 6 after surgery
Change in Harris Hip Score (HHS)
Timeframe: Baseline (preoperative or immediate postoperative) and Week 6 after surgery
Change in HOOS-12 total score
Timeframe: Baseline (preoperative or immediate postoperative) and Week 6 after surgery
Incidence of adverse events and device-related complications
Timeframe: From enrollment through Week 6 after surgery