Virtual Rehabilitation Platform for Patients With Knee Prothesis
NCT ID: NCT06720779
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-06-05
2025-07-05
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
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):
* Participants receive standard face-to-face rehabilitation twice a week, which involves 25 minutes of conventional rehabilitation (cryotherapy, joint mobilization, strength training, and gait re-education) and 20 minutes of gait exercises.
* Additionally, they perform four weekly 30-minute rehabilitation sessions at home using the TRAK platform.
* The TRAK platform incorporates advanced AI for movement tracking, gamification features, and personalized exercise routines.
Control Group (CG): Participants receive only the conventional rehabilitation protocol.
TREATMENT
NONE
Study Groups
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TRAK treatment group
Combined treatment of conventional rehabilitation plus virtual telerehabilitation treatment with the TRAK Platform.
TRAK physio knee prosthesis protocol
The exercise protocol designed for knee conditions is carried out through TRAK, the digital rehabilitation tool.
Knee conventional rehabilitation program
Exercise protocol with the methodology of conventional clinical practice.
Knee control group
Conventional face-to-face rehabilitation treatment.
Knee conventional rehabilitation program
Exercise protocol with the methodology of conventional clinical practice.
Interventions
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TRAK physio knee prosthesis protocol
The exercise protocol designed for knee conditions is carried out through TRAK, the digital rehabilitation tool.
Knee conventional rehabilitation program
Exercise protocol with the methodology of conventional clinical practice.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
85 Years
ALL
No
Sponsors
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Biocruces Bizkaia Health Research Institute
OTHER_GOV
Trak Health Solutions S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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RAÚL ZABALLA FERNÁNDEZ
Role: PRINCIPAL_INVESTIGATOR
Cruces University Hospital (HU Cruces)
Locations
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Cruces University Hospital (HU Cruces, OSI EEC)
Barakaldo, Basque Country, Spain
Countries
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Central Contacts
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Facility Contacts
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RAÚL ZABALLA FERNÁNDEZ
Role: primary
References
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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.
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.
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.
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.
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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.
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.
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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.
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.
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.
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.
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.
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 .
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.
Other Identifiers
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TRAK-CRUCES
Identifier Type: -
Identifier Source: org_study_id