Virtual Rehabilitation Platform for Patients With Knee Prothesis

NCT06720779 | Recruiting DMC

• 1 other identifier: TRAK-CRUCES
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Arthropathy

Keywords

telerehabilitation; telemedicine; exercise prescription; exercise program; knee replacement

Outcome Measures

Primary Outcomes (1)

• 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: * Muscle balance = 4 in quadriceps and hamstrings according to the Medical Research Council (MRC). * Joint balance between 0-100 degrees of flexion, measured by goniometer * VAS scale \<4 * Stable gait

  Visit 5 (week 12)

Secondary Outcomes (13)

• WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)

  visits 1 (Week 1) and 5 (Week 12) for both goups

• Knee flexion articular balance

  Visits 1 (week 1) to 5 (week 12) for both groups

• TRAK platform knee flexion test

  Visits 1 (week 1) to 5 (week 12) only on the intervention group

• MRC (Medical Research Council) scale

  Visits 1 (week 1) to 5 (week 12) for both groups

• 10 meter walk test

  visits 2 (Week 2) and 5 (Week 12) for both goups

Study Arms (2)

TRAK treatment group

EXPERIMENTAL

Combined treatment of conventional rehabilitation plus virtual telerehabilitation treatment with the TRAK Platform.

Other: TRAK physio knee prosthesis protocol; Other: Knee conventional rehabilitation program

Knee control group

ACTIVE COMPARATOR

Conventional face-to-face rehabilitation treatment.

Other: Knee conventional rehabilitation program

Interventions

TRAK physio knee prosthesis protocol OTHER

The exercise protocol designed for knee conditions is carried out through TRAK, the digital rehabilitation tool.

TRAK treatment group

Knee conventional rehabilitation program OTHER

Exercise protocol with the methodology of conventional clinical practice.

Knee control group; TRAK treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trak Health Solutions S.L.: lead
• Biobizkaia Health Research Institute: collaborator

Study Sites (1)

Cruces University Hospital (HU Cruces, OSI EEC)

Barakaldo, Basque Country, 20018, Spain

RECRUITING

Related Publications (16)

• 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 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.

  PMID: 18588820 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.

  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.

  PMID: 22552131 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.

  PMID: 28802773 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.

  PMID: 18687278 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.

  PMID: 36586244 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.

  PMID: 36692413 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.

  PMID: 29738442 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.

  PMID: 35549756 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.

  PMID: 31743238 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.

  PMID: 33561280 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.

  PMID: 28771070 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.

  PMID: 28027679 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 .

  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.

  PMID: 28575058 BACKGROUND

Study Officials

• RAÚL ZABALLA FERNÁNDEZ

  Cruces University Hospital (HU Cruces)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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): * 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.

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 6, 2024
• Study Start: June 5, 2024
• Primary Completion: June 5, 2025
• Study Completion: July 5, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

ES (1)