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Knee ArthropathyNCT06720779

Virtual Rehabilitation Platform for Patients With Knee Prothesis

A study testing TRAK physio knee prosthesis protocol and Knee conventional rehabilitation program in people with Knee Arthropathy, run by Trak Health Solutions S.L. at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Knee Arthropathy
What is being tested?
TRAK physio knee prosthesis protocol and Knee conventional rehabilitation program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSpain
Study dates
5 Jun 2024to 5 Jul 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Spain1 site, 1 recruiting

  • Cruces University Hospital (HU Cruces, OSI EEC)

    Barakaldo, Basque Country, 20018

    RAÚL ZABALLA FERNÁNDEZ, 00 34 946 00 60 00, RAUL.ZABALLAFERNANDEZ@osakidetza.eus

    RAÚL ZABALLA FERNÁNDEZ

    Recruiting

Other trials in Spain

About this study

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

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.

Read more

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.
Read the 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.

Being tested
TRAK physio knee prosthesis protocol, Knee conventional rehabilitation program
Keywords
telerehabilitation, telemedicine, exercise prescription, exercise program, knee replacement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRAK physio knee prosthesis protocolOther

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

  • Knee conventional rehabilitation programOther

    Exercise protocol with the methodology of conventional clinical practice.

Study groups in NCT06720779
Study groupRoleWhat they receive
TRAK treatment groupExperimentalCombined treatment of conventional rehabilitation plus virtual telerehabilitation treatment with the TRAK Platform.
Receives: Other: TRAK physio knee prosthesis protocol; Other: Knee conventional rehabilitation program
Knee control groupActive comparatorConventional face-to-face rehabilitation treatment.
Receives: Other: Knee conventional rehabilitation program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Visit 5 (week 12)

Secondary outcomes (13)

  1. 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.

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

  2. Knee flexion articular balance

    Knee flexion range of motion measured with a goniometer

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

  3. TRAK platform knee flexion test

    Knee flexion measured by video on the TRAK platform

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

  4. MRC (Medical Research Council) scale

    Strength test for the cuadriceps muscle. The results go from Grade 5 (normal) to Grade 0 (no visible contraction).

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

  5. 10 meter walk test

    Time and speed in 10 meter walk

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

  6. 6 minute walk test

    Distance covered on a 6 minute walk

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

  7. 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.

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

  8. Stable gait assessment Y/N

    Stable running or not depending on the professional's judgement

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

  9. VAS scale

    Scale used by the patient to measure pain from 1 to 10 being 1 no pain and 10 the highest pain posible

    Measured: visits 1 (week 1) to 5 (week 2) for both goups

  10. 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.

    Measured: visits 1 (week 1) and 5 (week 12) for both goups

  11. 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.

    Measured: visits 1 (week 1) to 5 (week 12) for both goups

  12. 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.

    Measured: Visit 5 (week 12) on the intervention group

  13. 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.

    Measured: visits 1 (week 1) and 5 (week 12) for both goups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2024
  2. Study start5 Jun 2024
  3. Primary completion5 Jun 2025 (estimated)
  4. Study completion5 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06720779
Sponsor's protocol ID
TRAK-CRUCES
Status last verified
Dec 2024
First submitted
20 Nov 2024
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 36692413

  • 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.

    PubMed 29738442

  • 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.

    PubMed 35549756

  • 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.

    PubMed 31743238

  • 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.

    PubMed 33561280

  • 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.

    PubMed 28771070

  • 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.

    PubMed 28027679

  • 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 .

Questions about this trial

What is this clinical trial studying?

A study testing TRAK physio knee prosthesis protocol and Knee conventional rehabilitation program in people with Knee Arthropathy, run by Trak Health Solutions S.L. at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact JUAN F DUARTE MENDOZA (+34 677 33 4869, juanfernando@trak.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06720779, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

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