NCT07448792

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

Prospective, Randomized, Partially Blinded, Multicenter Non-Inferiority Trial of the EUKINES Wearable Plantar-Pressure Insole Gait-Analysis System for Postoperative Rehabilitation After Primary Total Hip Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Cardinal Stefan Wyszynski University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, randomized, partially blinded, multicenter clinical trial with a non-inferiority design conducted in patients undergoing primary total hip arthroplasty (THA) for advanced osteoarthritis. The study is embedded in the EUKINES project, which develops low-cost, printable pressure sensors and a wearable plantar-pressure insole system intended for scalable clinical rehabilitation and telerehabilitation use. The trial evaluates the clinical performance, safety, and usability of the EUKINES insole system as an adjunct to standard postoperative rehabilitation. Adult patients scheduled for primary THA will be screened according to predefined inclusion and exclusion criteria and enrolled after providing written informed consent. A total of 200 participants will be randomized in blocks to one of four parallel rehabilitation arms: (1) EUKINES with real-time biofeedback, (2) EUKINES without biofeedback (data recording only), (3) a certified commercial reference gait-analysis system with biofeedback, or (4) standard rehabilitation without any gait-analysis device. All participants will follow the same structured 6-week rehabilitation program after surgery, including routine physiotherapy and six additional, approximately 3-hour gait-focused sessions. The content and duration of rehabilitation are equivalent across groups; only the use of gait-analysis devices and biofeedback differs between arms. Outcome assessments will be performed at baseline and during postoperative follow-up. Primary endpoints include changes in plantar-pressure-derived gait parameters such as mean foot pressure and load asymmetry between the operated and non-operated limb, as well as changes in hip-related clinical scores (Harris Hip Score and the 12-item Hip Disability and Osteoarthritis Outcome Score, HOOS-12) and the incidence of adverse events and device-related complications. Secondary outcomes include extended spatiotemporal gait parameters, 10-Meter Walk Test performance, pain intensity and satisfaction with surgery and rehabilitation, and patient and therapist ratings of usability, comfort, and perceived usefulness of the EUKINES and reference systems. All plantar-pressure time-series data will be stored to allow post-hoc derivation of additional gait metrics and exploratory analyses. The study is classified as a low-risk, add-on interventional trial that does not alter standard surgical procedures or baseline postoperative care. Device-assisted rehabilitation sessions are provided as an adjunct to routine practice. The trial is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice, under the oversight of a bioethics committee. By directly comparing the EUKINES prototype with a certified commercial reference system and standard care, the study aims to demonstrate the feasibility and clinical usefulness of an affordable sensor-based gait-analysis platform and to provide a basis for future development of data-driven telerehabilitation and personalized rehabilitation strategies.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-15
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2026-03-04
• Last updated: 2026-03-04

Locations

1 site across 1 country: Poland