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NCT Number: NCT06720779

Virtual Rehabilitation Platform for Patients With Knee Prothesis

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.

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Key information

Conditions

Knee Arthropathy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cruces University Hospital (HU Cruces, OSI EEC)

Barakaldo, Basque Country, 20018, Spain

Location status: Recruiting

Location contact

RAÚL ZABALLA FERNÁNDEZ

CONTACT

[email protected]

00 34 946 00 60 00

RAÚL ZABALLA FERNÁNDEZ

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TRAK physio knee prosthesis protocol

Other

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

Knee conventional rehabilitation program

Other

Exercise protocol with the methodology of conventional clinical practice.

Primary outcomes

  1. 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)

    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

Secondary outcomes

  1. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)

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

    Life quality questionnaire. The results go from 0 to 98 being 0 the worst life quality and 98 the best.

  2. Knee flexion articular balance

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

    Knee flexion range of motion measured with a goniometer

  3. TRAK platform knee flexion test

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

    Knee flexion measured by video on the TRAK platform

  4. MRC (Medical Research Council) scale

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

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

  5. 10 meter walk test

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

    Time and speed in 10 meter walk

  6. 6 minute walk test

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

    Distance covered on a 6 minute walk

  7. Up and go test

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

    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.

  8. Stable gait assessment Y/N

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

    Stable running or not depending on the professional's judgement

  9. VAS scale

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

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

  10. 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

    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.

  11. Functional Knee Scale KOOS-PS (Knee Injury and Osteoarthritis Outcome Score)

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

    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.

  12. Patient satisfaction survey on the use of the TRAK Platform

    Time frame: Visit 5 (week 12) on the intervention group

    Questionnaire used on the TRAK platform to measure the patient satisfaction being 0 the worst satisfaction and 12 the best.

  13. EQ-5D-5L Questionnaire

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

JUAN F DUARTE MENDOZA

CONTACT

[email protected]

+34 677 33 4869

RAÚL ZABALLA FERNÁNDEZ

CONTACT

[email protected]

+34 946 00 60 00

Sponsors and collaborators

Lead sponsor

Trak Health Solutions S.L.

Industry

Collaborators

  • Biobizkaia Health Research Institute

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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