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

NCT07448792 | Completed

• 2 other identifiers: UKSW/EUKINES-THA-01TECHMATSTRATEG-III-0032-2019
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gait analysis; rehabilitation; plantar-pressure insoles; wearable sensors; printed sensors; biofeedback; telerehabilitation; total hip arthroplasty; mean foot pressure; EUKINES

Outcome Measures

Primary Outcomes (5)

• Change in mean foot pressure (MFP) on the operated limb

  Mean foot pressure (MFP) is defined as the average plantar pressure across all active sensing regions of the insole during the stance phase of gait, expressed in kilopascals. MFP will be recorded during standardized 10-meter walking trials using the EUKINES and/or reference insole systems, and session-level MFP will be calculated as the mean value across all valid steps. The primary analysis will compare changes in MFP on the operated limb over time and between rehabilitation arms.

  Baseline (Week 0), Week 3, Week 6 after surgery

• Change in load asymmetry between operated and non-operated limb

  Load asymmetry will be quantified using plantar-pressure data from the EUKINES and/or reference insole systems as the difference or ratio between mean foot pressure on the operated and non-operated limb during standardized 10-meter walking trials. Reduced inter-limb asymmetry over time will be interpreted as improved functional load distribution after total hip arthroplasty.

  Baseline (Week 0), Week 3, Week 6 after surgery

• Change in Harris Hip Score (HHS)

  The Harris Hip Score is a validated clinician-administered scale assessing pain, function, range of motion, and absence of deformity in patients after hip surgery. Total scores range from 0 to 100, with higher scores indicating better hip function. The primary analysis will compare changes in HHS from baseline to Week 6 between rehabilitation arms.

  Baseline (preoperative or immediate postoperative) and Week 6 after surgery

• Change in HOOS-12 total score

  The HOOS-12 is a validated 12-item short form of the Hip Disability and Osteoarthritis Outcome Score that assesses pain, function, and quality of life in hip patients. Scores are transformed to a 0-100 scale, with higher scores indicating better outcomes. The main analysis will evaluate changes in HOOS-12 total score from baseline to Week 6, with reference to the minimal clinically important difference of approximately 9-12 points reported in the literature.

  Baseline (preoperative or immediate postoperative) and Week 6 after surgery

• Incidence of adverse events and device-related complications

  Safety will be assessed by recording all adverse events, device-related complications, skin irritation, falls, or other medical incidents potentially associated with device use or the supplementary rehabilitation sessions. Events will be classified by severity, relationship to the device or intervention, and outcome.

  From enrollment through Week 6 after surgery

Secondary Outcomes (7)

• Preferred walking speed (10-Meter Walk Test)

  Baseline, Week 3, Week 6

• Change in maximal walking speed (10-Meter Walk Test)

  Baseline, Week 3, Week 6

• Change in spatiotemporal gait parameters derived from plantar-pressure insoles

  Additional gait parameters (e.g., cadence, stance and swing phase duration, rollover time) will be derived from plantar-pressure time-series data and analyzed as exploratory secondary outcomes.

• Change in hip pain intensity (VAS)

  Baseline, Week 3, Week 6

• Change in patient satisfaction with surgery and rehabilitation measured with a Visual Analogue Scale (VAS)

  Week 3 and Week 6

Study Arms (4)

EUKINES with biofeedback

EXPERIMENTAL

Participants receive the structured postoperative rehabilitation program supported by the EUKINES plantar-pressure insole system with real-time biofeedback on gait parameters during the additional rehabilitation sessions.

Device: EUKINES plantar-pressure insole system; Other: Structured postoperative rehabilitation program

EUKINES without biofeedback

EXPERIMENTAL

Participants receive the structured postoperative rehabilitation program while wearing the EUKINES plantar-pressure insole system without real-time biofeedback; gait data are recorded for analysis only during the additional rehabilitation sessions.

Device: EUKINES plantar-pressure insole system; Other: Structured postoperative rehabilitation program

Reference system with biofeedback

ACTIVE COMPARATOR

Participants receive the structured postoperative rehabilitation program supported by a certified commercial plantar-pressure gait-analysis system providing real-time biofeedback on gait parameters during the additional rehabilitation sessions.

Device: Certified reference gait-analysis system; Other: Structured postoperative rehabilitation program

Standard rehabilitation

ACTIVE COMPARATOR

Participants receive the same structured postoperative rehabilitation program without any gait-analysis device or biofeedback; rehabilitation is based on standard clinical practice at participating centers.

Other: Structured postoperative rehabilitation program

Interventions

Certified reference gait-analysis system DEVICE

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.

Reference system with biofeedback

EUKINES plantar-pressure insole system DEVICE

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.

EUKINES with biofeedback; EUKINES without biofeedback

Structured postoperative rehabilitation program OTHER

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.

EUKINES with biofeedback; EUKINES without biofeedback; Reference system with biofeedback; Standard rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Scheduled for primary total hip arthroplasty performed for advanced osteoarthritis or other degenerative hip disease.
• Willingness and ability to participate in the 6-week postoperative rehabilitation program and follow-up assessments.
• Ability to understand study information and provide written informed consent.

You may not qualify if:

• Coexisting medical conditions that may significantly affect rehabilitation outcomes or gait (e.g., severe neurological disorders, major lower-limb joint trauma, other significant musculoskeletal pathology).
• Cognitive impairment or psychiatric conditions that would preclude effective cooperation with the rehabilitation and research team.
• Any contraindication to participation in additional gait training sessions or use of the insole-based gait-analysis systems as judged by the treating physician.

Sponsors & Collaborators

• Cardinal Stefan Wyszynski University: lead
• National Center for Research and Development, Poland: collaborator
• Warsaw University of Technology: collaborator

Study Sites (1)

Cardinal Stefan Wyszynski University in Warsaw, Collegium Medicum - Affiliated Orthopaedic Department

Warsaw, Masovian Voivodeship, 01-938, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Andrzej Kotela

  Cardinal Stefan Wyszynski University in Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors responsible for postoperative follow-up visits and clinical evaluations are blinded to group allocation. Patients, care providers, and rehabilitation staff are aware of the assigned intervention because of the visible use or non-use of gait-analysis devices.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Four-arm parallel-group trial with patients allocated to EUKINES with biofeedback, EUKINES without biofeedback, a certified reference gait-analysis system with biofeedback, or standard rehabilitation without a gait-analysis device.

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 4, 2026
• Study Start: December 15, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)