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| Name | Class |
|---|---|
| Biobizkaia Health Research Institute | OTHER_GOV |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRAK treatment group | Experimental | Combined treatment of conventional rehabilitation plus virtual telerehabilitation treatment with the TRAK Platform. |
|
| Knee control group | Active Comparator | Conventional face-to-face rehabilitation treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRAK physio knee prosthesis protocol | Other | The exercise protocol designed for knee conditions is carried out through TRAK, the digital rehabilitation tool. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of face-to-face rehabilitation sessions required for each patient to reach the optimal level of function for discharge | Sessions required to reach the next criteria:
| Visit 5 (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) | Life quality questionnaire. The results go from 0 to 98 being 0 the worst life quality and 98 the best. | visits 1 (Week 1) and 5 (Week 12) for both goups |
| Knee flexion articular balance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JUAN F DUARTE MENDOZA | Contact | +34 677 33 4869 | juanfernando@trak.es | |
| RAÚL ZABALLA FERNÁNDEZ | Contact | +34 946 00 60 00 | RAUL.ZABALLAFERNANDEZ@osakidetza.eus |
| Name | Affiliation | Role |
|---|---|---|
| RAÚL ZABALLA FERNÁNDEZ | Cruces University Hospital (HU Cruces) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cruces University Hospital (HU Cruces, OSI EEC) | Recruiting | Barakaldo | Basque Country | 20018 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16606556 | Background | 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. | |
| 18588820 |
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Twenty patients will be randomly assigned to the experimental or control group in a 1:1 ratio.
Opaque envelopes containing the randomization sequence will be prepared to maintain allocation concealment. Patients meeting the inclusion criteria and agreeing to participate will be consecutively recruited.
Experimental Group (EG):
Control Group (CG): Participants receive only the conventional rehabilitation protocol.
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| Knee conventional rehabilitation program | Other | Exercise protocol with the methodology of conventional clinical practice. |
|
Knee flexion range of motion measured with a goniometer |
| Visits 1 (week 1) to 5 (week 12) for both groups |
| TRAK platform knee flexion test | Knee flexion measured by video on the TRAK platform | Visits 1 (week 1) to 5 (week 12) only on the intervention group |
| MRC (Medical Research Council) scale | Strength test for the cuadriceps muscle. The results go from Grade 5 (normal) to Grade 0 (no visible contraction). | Visits 1 (week 1) to 5 (week 12) for both groups |
| 10 meter walk test | Time and speed in 10 meter walk | visits 2 (Week 2) and 5 (Week 12) for both goups |
| 6 minute walk test | Distance covered on a 6 minute walk | visits 2 (Week 2) and 5 (Week 12) for both goups |
| Up and go test | the time, in seconds, it takes for an individual to get up from a standard chair, walk a distance of 3 meters, turn around, walk back to the chair and sit down again. | visits 2 (Week 2) and 5 (Week 12) for both goups |
| Stable gait assessment Y/N | Stable running or not depending on the professional's judgement | visits 2 (Week 2) and 5 (Week 12) for both goups |
| VAS scale | Scale used by the patient to measure pain from 1 to 10 being 1 no pain and 10 the highest pain posible | visits 1 (week 1) to 5 (week 2) for both goups |
| Kujala Score or Anterior Knee Pain Scale (AKPS) on the TRAK platform | Self-administered patient questionnaire consisting of 13 questions related to specific activities, severity of pain and clinical symptoms. It assesses subjective reactions to particular activities and symptoms that are known to correlate with anterior knee pain syndrome. It is graded from 0 to 100, with 0 being the highest pain severity and 0 the lowest. | visits 1 (week 1) and 5 (week 12) for both goups |
| Functional Knee Scale KOOS-PS (Knee Injury and Osteoarthritis Outcome Score) | is used to assess patient-relevant outcomes following a knee injury. The results range from zero representing extreme knee problems to 100 representing no knee problems. | visits 1 (week 1) to 5 (week 12) for both goups |
| Patient satisfaction survey on the use of the TRAK Platform | Questionnaire used on the TRAK platform to measure the patient satisfaction being 0 the worst satisfaction and 12 the best. | Visit 5 (week 12) on the intervention group |
| EQ-5D-5L Questionnaire | Quality of life measurement questionnaire that can be used both in relatively healthy individuals (general population) and in groups of patients with different pathologies. The restults range from 0 to 100, where 100 is the best possible health state and 0 the worst. | visits 1 (week 1) and 5 (week 12) for both goups |
| Background |
| 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. |
| Background | 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. |
| 22552131 | Background | 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. |
| 28802773 | Background | 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. |
| 18687278 | Background | 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. |
| 36586244 | Background | 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. |
| 36692413 | Background | 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. |
| 29738442 | Background | Anton D, Berges I, Bermudez J, Goni A, Illarramendi A. A Telerehabilitation System for the Selection, Evaluation and Remote Management of Therapies. Sensors (Basel). 2018 May 8;18(5):1459. doi: 10.3390/s18051459. |
| 35549756 | Background | Tsang MP, Man GCW, Xin H, Chong YC, Ong MT, Yung PS. The effectiveness of telerehabilitation in patients after total knee replacement: A systematic review and meta-analysis of randomized controlled trials. J Telemed Telecare. 2024 Jun;30(5):795-808. doi: 10.1177/1357633X221097469. Epub 2022 May 12. |
| 31743238 | Background | Prvu Bettger J, Green CL, Holmes DN, Chokshi A, Mather RC 3rd, Hoch BT, de Leon AJ, Aluisio F, Seyler TM, Del Gaizo DJ, Chiavetta J, Webb L, Miller V, Smith JM, Peterson ED. Effects of Virtual Exercise Rehabilitation In-Home Therapy Compared with Traditional Care After Total Knee Arthroplasty: VERITAS, a Randomized Controlled Trial. J Bone Joint Surg Am. 2020 Jan 15;102(2):101-109. doi: 10.2106/JBJS.19.00695. |
| 33561280 | Background | Seron P, Oliveros MJ, Gutierrez-Arias R, Fuentes-Aspe R, Torres-Castro RC, Merino-Osorio C, Nahuelhual P, Inostroza J, Jalil Y, Solano R, Marzuca-Nassr GN, Aguilera-Eguia R, Lavados-Romo P, Soto-Rodriguez FJ, Sabelle C, Villarroel-Silva G, Gomolan P, Huaiquilaf S, Sanchez P. Effectiveness of Telerehabilitation in Physical Therapy: A Rapid Overview. Phys Ther. 2021 Jun 1;101(6):pzab053. doi: 10.1093/ptj/pzab053. |
| 28771070 | Background | Azma K, RezaSoltani Z, Rezaeimoghaddam F, Dadarkhah A, Mohsenolhosseini S. Efficacy of tele-rehabilitation compared with office-based physical therapy in patients with knee osteoarthritis: A randomized clinical trial. J Telemed Telecare. 2018 Sep;24(8):560-565. doi: 10.1177/1357633X17723368. Epub 2017 Aug 3. |
| 28027679 | Background | Jiang S, Xiang J, Gao X, Guo K, Liu B. The comparison of telerehabilitation and face-to-face rehabilitation after total knee arthroplasty: A systematic review and meta-analysis. J Telemed Telecare. 2018 May;24(4):257-262. doi: 10.1177/1357633X16686748. Epub 2016 Dec 27. |
| Background | Telerehabilitation tool applied in patients with musculoskeletal pathology: a study of the benefit https://docs.google.com/document/d/1fTzkUtg7R5apoxYZhSnFBb1SSTVZ e-xssOjCBcD9WKU/edit#heading=h.8sdbqdb9ue6x . |
| 28575058 | Background | Masaracchio M, Hanney WJ, Liu X, Kolber M, Kirker K. Timing of rehabilitation on length of stay and cost in patients with hip or knee joint arthroplasty: A systematic review with meta-analysis. PLoS One. 2017 Jun 2;12(6):e0178295. doi: 10.1371/journal.pone.0178295. eCollection 2017. |