EUKINES Wearable Plantar-Pressure Insole System for Rehabilitation After Total Hip Arthroplasty

Summary

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.

Conditions

• Hip Osteoarthritis
• Total Hip Arthroplasty (THA)
• Postoperative Rehabilitation

Interventions

DEVICE

Certified reference gait-analysis system

Commercially available, certified plantar-pressure gait-analysis system used according to the manufacturer's recommendations to provide real-time biofeedback on gait parameters during rehabilitation sessions.

DEVICE

EUKINES plantar-pressure insole system

Wearable plantar-pressure insole system developed within the EUKINES project, consisting of thin-film printed pressure sensors, shoe-mounted electronic modules, and PC-based software for real-time gait data acquisition and visualization. In the biofeedback arm, real-time feedback on gait parameters is provided during rehabilitation sessions; in the non-biofeedback arm, data are recorded without feedback.

OTHER

Structured postoperative rehabilitation program

Standard postoperative rehabilitation program after total hip arthroplasty, delivered according to local clinical protocols and including six additional approximately 3-hour gait-focused rehabilitation sessions over 6 weeks, with progressive gait training, balance and coordination exercises, and functional mobility tasks.

Sponsors & Collaborators

• National Center for Research and Development, Poland

  collaborator OTHER

• Warsaw University of Technology

  collaborator OTHER

• Cardinal Stefan Wyszynski University

  lead OTHER

Principal Investigators

• Andrzej Kotela · Cardinal Stefan Wyszynski University in Warsaw

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-15

Primary Completion

2025-11-30

Completion

2025-11-30

Countries

• Poland

Study Locations