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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cardinal Stefan Wyszynski University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in mean foot pressure (MFP) on the operated limb
Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
EUKINES with biofeedback
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.
Intervention: EUKINES plantar-pressure insole system (Device)
EUKINES with biofeedback
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.
Intervention: Structured postoperative rehabilitation program (Other)
EUKINES without biofeedback
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.
Intervention: EUKINES plantar-pressure insole system (Device)
EUKINES without biofeedback
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.
Intervention: Structured postoperative rehabilitation program (Other)
Reference system with biofeedback
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.
Intervention: Certified reference gait-analysis system (Device)
Reference system with biofeedback
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.
Intervention: Structured postoperative rehabilitation program (Other)
Standard rehabilitation
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.
Intervention: Structured postoperative rehabilitation program (Other)
Outcomes
Primary Outcomes
Change in mean foot pressure (MFP) on the operated limb
Time Frame: Baseline (Week 0), Week 3, Week 6 after surgery
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.
Change in load asymmetry between operated and non-operated limb
Time Frame: Baseline (Week 0), Week 3, Week 6 after surgery
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.
Change in Harris Hip Score (HHS)
Time Frame: Baseline (preoperative or immediate postoperative) and Week 6 after surgery
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.
Change in HOOS-12 total score
Time Frame: Baseline (preoperative or immediate postoperative) and Week 6 after surgery
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.
Incidence of adverse events and device-related complications
Time Frame: From enrollment through Week 6 after surgery
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.
Secondary Outcomes
- 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)
- Patient-reported usability and comfort of the EUKINES and reference systems (study-specific 15-item Likert-scale questionnaire)(Week 3 and Week 6)
- Therapist-reported usability and perceived usefulness of the EUKINES and reference systems (study-specific 12-item Likert-scale questionnaire)(Throughout the 6-week rehabilitation period)