Clinical trial NCT06720779: Virtual Rehabilitation Platform for Patients With Knee Prothesis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Arthropathy
Keywords: telerehabilitation
telemedicine
exercise prescription
exercise program
knee replacement
Lead sponsor: Trak Health Solutions S.L.
Sponsor class: INDUSTRY
Collaborators: name: Biocruces Bizkaia Health Research Institute
First posted: 2024-12-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of face-to-face rehabilitation sessions required for each patient to reach the optimal level of function for discharge
timeFrame: Visit 5 (week 12)
Secondary outcomes:
measure: WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
timeFrame: visits 1 (Week 1) and 5 (Week 12) for both goups
measure: Knee flexion articular balance
timeFrame: Visits 1 (week 1) to 5 (week 12) for both groups
measure: TRAK platform knee flexion test
timeFrame: Visits 1 (week 1) to 5 (week 12) only on the intervention group
measure: MRC (Medical Research Council) scale
timeFrame: Visits 1 (week 1) to 5 (week 12) for both groups
measure: 10 meter walk test
timeFrame: visits 2 (Week 2) and 5 (Week 12) for both goups
measure: 6 minute walk test
timeFrame: visits 2 (Week 2) and 5 (Week 12) for both goups
measure: Up and go test
timeFrame: visits 2 (Week 2) and 5 (Week 12) for both goups
measure: Stable gait assessment Y/N
timeFrame: visits 2 (Week 2) and 5 (Week 12) for both goups
measure: VAS scale
timeFrame: visits 1 (week 1) to 5 (week 2) for both goups
measure: Kujala Score or Anterior Knee Pain Scale (AKPS) on the TRAK platform
timeFrame: visits 1 (week 1) and 5 (week 12) for both goups
measure: Functional Knee Scale KOOS-PS (Knee Injury and Osteoarthritis Outcome Score)
timeFrame: visits 1 (week 1) to 5 (week 12) for both goups
measure: Patient satisfaction survey on the use of the TRAK Platform
timeFrame: Visit 5 (week 12) on the intervention group
measure: EQ-5D-5L Questionnaire
timeFrame: visits 1 (week 1) and 5 (week 12) for both goups
Other outcomes:
Locations:
city: Baracaldo
country: Spain
facility: Cruces University Hospital (HU Cruces, OSI EEC)
state: País Vasco
Study officials:
affiliation: Cruces University Hospital (HU Cruces)
name: RAÚL ZABALLA FERNÁNDEZ
role: PRINCIPAL_INVESTIGATOR
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