Virtual Rehabilitation Platform for Patients With Knee Prothesis

Official title

A Randomized Clinical Trial to Evaluate the Effectiveness of Telerehabilitation With Trak in Combination With the Traditional Treatment in Patients Who Have Undergone Knee Prothesis Surgery

Overview

This clinical trial aims to evaluate the effectiveness and usability of the Trak Rehabilitation Platform in patients who have undergone knee replacement surgery. Its main questions are whether the Trak platform combined with conventional therapy helps patients achieve optimal functionality with fewer in-person sessions compared to conventional rehabilitation alone and whether the Trak platform improves adherence to treatment, independence in daily activities, and quality of life while reducing resource consumption. Researchers will compare the use of the Trak platform combined with conventional rehabilitation to standard rehabilitation practices to determine its impact on functional outcomes, patient and provider satisfaction, and resource efficiency. Participants will: * Use the Trak Platform as part of their personalized treatment plan. * Attend face-to-face rehabilitation sessions as prescribed. * Participate in assessments to measure functionality, adherence, independence, quality of life, and resource utilization.

Detailed description

This randomized, controlled, single-center clinical trial conducted at Cruces University Hospital focuses on enhancing recovery outcomes by integrating telerehabilitation into conventional therapy.

The trial involves two parallel groups: an experimental group (EG) using the TRAK platform and conventional face-to-face rehabilitation and a control group (CG) undergoing the last methodology (conventional rehabilitation) alone. Participants in the EG will perform four weekly 30-minute at-home sessions on the TRAK platform, which utilizes artificial intelligence for real-time movement guidance, posture correction, and gamified motivation. Conventional therapy in both groups includes bi-weekly sessions of cryotherapy, joint mobilization, strength exercises, and gait re-education. This hybrid approach aims to personalize care, optimize functionality, and reduce the required face-to-face sessions.

Primary outcomes focus on reducing on-site rehabilitation sessions needed for functional recovery, while secondary outcomes assess adherence, independence, quality of life, and patient satisfaction. Data will be collected through validated questionnaires, biomechanical tests, and metrics from the TRAK system during baseline and four follow-up visits at 2, 4, 6, and 12 weeks.

Healthcare professionals will receive training to ensure the effective use of the TRAK system. Ethical approval has been secured, and all participants will provide informed consent, ensuring compliance with the Declaration of Helsinki and GDPR.

This study seeks to validate the TRAK platform's integration into clinical practice as a cost-effective and scalable solution to improve musculoskeletal rehabilitation outcomes. The findings will contribute to advancing digital health solutions in post-surgical recovery by exploring their usability and clinical impact.

Interventions

• Other TRAK physio knee prosthesis protocol
  The exercise protocol designed for knee conditions is carried out through TRAK, the digital rehabilitation tool.
• Other Knee conventional rehabilitation program
  Exercise protocol with the methodology of conventional clinical practice.

Primary outcome measures

• Number of face-to-face rehabilitation sessions required for each patient to reach the optimal level of function for discharge [Time frame: Visit 5 (week 12)]

Secondary outcome measures (12)

• WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) [Time frame: visits 1 (Week 1) and 5 (Week 12) for both goups]
• Knee flexion articular balance [Time frame: Visits 1 (week 1) to 5 (week 12) for both groups]
• TRAK platform knee flexion test [Time frame: Visits 1 (week 1) to 5 (week 12) only on the intervention group]
• MRC (Medical Research Council) scale [Time frame: Visits 1 (week 1) to 5 (week 12) for both groups]
• 10 meter walk test [Time frame: visits 2 (Week 2) and 5 (Week 12) for both goups]
• 6 minute walk test [Time frame: visits 2 (Week 2) and 5 (Week 12) for both goups]
• Up and go test [Time frame: visits 2 (Week 2) and 5 (Week 12) for both goups]
• Stable gait assessment Y/N [Time frame: visits 2 (Week 2) and 5 (Week 12) for both goups]
• VAS scale [Time frame: visits 1 (week 1) to 5 (week 2) for both goups]
• Kujala Score or Anterior Knee Pain Scale (AKPS) on the TRAK platform [Time frame: visits 1 (week 1) and 5 (week 12) for both goups]
• Functional Knee Scale KOOS-PS (Knee Injury and Osteoarthritis Outcome Score) [Time frame: visits 1 (week 1) to 5 (week 12) for both goups]
• Patient satisfaction survey on the use of the TRAK Platform [Time frame: Visit 5 (week 12) on the intervention group]

Eligibility criteria

Inclusion criteria

• Patients aged >18 and ≤85 years.
• Patients who underwent surgery for the implantation of a knee prosthesis at the Knee Unit of the Cruces University Hospital.
• Patients who require on-site rehabilitation at the Cruces university hospital rehabilitation service.
• Patients who have signed the Informed Consent.

Exclusion criteria

• Patients with intellectual disability or cognitive impairment.
• Patients with a history of knee infection.
• Patients who cannot make use of mobile applications, cell phones, tablets, laptops or e- mail and who do not have the support of a family member or caregiver to provide support to make use of these technologies.
• Patients who have not signed the Informed Consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• Cruces University Hospital (HU Cruces, OSI EEC) — Barakaldo

Publications

• Garcia-Pont J, Blanch-Falp J, Coll-Colell R, Rosell-Abaurrea F, Tapiz-Reula A, Dorca-Badia E, Masabeu-Urrutia A, Martin-Urda A, Barrufet-Barque P, Force-Sanmartin L; Grupo de Estudio de la Infeccion de Protesis. [Prosthetic joint infection: a prospective study in five Catalonian hospitals]. Enferm Infecc Microbiol Clin. 2006 Mar;24(3):157-61. doi: 10.1157/13086547. Spanish. PMID 16606556
• Ariza J, Euba G, Murillo O. [Orthopedic device-related infections]. Enferm Infecc Microbiol Clin. 2008 Jun-Jul;26(6):380-90. doi: 10.1157/13123843. Spanish. PMID 18588820
• S. Castiella-Muruzábal, M.A. López-Vázquez, J. No-Sánchez, I. García-Fraga, J. Suárez-Guijarro, T. Bañales-MendozaArtroplastia de rodilla. Revisión. Rehabilitación (Madr), 41 (2007), pp. 290-308.
• Lopez-Liria R, Vega-Ramirez F, Catalan-Matamoros D, Padilla Gongora D, Martinez-Cortes M, Mesa-Ruiz A. [Home care rehabilitation and physiotherapy in knee prosthesis]. An Sist Sanit Navar. 2012 Jan-Apr;35(1):99-113. doi: 10.4321/s1137-66272012000100009. Spanish. PMID 22552131
• Henderson KG, Wallis JA, Snowdon DA. Active physiotherapy interventions following total knee arthroplasty in the hospital and inpatient rehabilitation settings: a systematic review and meta-analysis. Physiotherapy. 2018 Mar;104(1):25-35. doi: 10.1016/j.physio.2017.01.002. Epub 2017 Feb 1. PMID 28802773
• Hunter DJ, Lo GH. The management of osteoarthritis: an overview and call to appropriate conservative treatment. Rheum Dis Clin North Am. 2008 Aug;34(3):689-712. doi: 10.1016/j.rdc.2008.05.008. PMID 18687278
• Hao J, Pu Y, Chen Z, Siu KC. Effects of virtual reality-based telerehabilitation for stroke patients: A systematic review and meta-analysis of randomized controlled trials. J Stroke Cerebrovasc Dis. 2023 Mar;32(3):106960. doi: 10.1016/j.jstrokecerebrovasdis.2022.106960. Epub 2022 Dec 29. PMID 36586244
• Batalik L, Filakova K, Sladeckova M, Dosbaba F, Su J, Pepera G. The cost-effectiveness of exercise-based cardiac telerehabilitation intervention: a systematic review. Eur J Phys Rehabil Med. 2023 Apr;59(2):248-258. doi: 10.23736/S1973-9087.23.07773-0. Epub 2023 Jan 24. PMID 36692413

Identifiers

NCT: NCT06720779 · TRAK-CRUCES

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗