Virtual Rehabilitation Platform for Patients With Knee Prothesis

Not Applicable

Recruiting

• Conditions: Knee Arthropathy

• Registration Number: NCT06720779
• Lead Sponsor: Trak Health Solutions S.L.

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.

Study Timeline

• Study Start: 2024-06-05
• Study First Submitted: 2024-11-20
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-06-05
• Study Completion: 2025-07-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of face-to-face rehabilitation sessions required for each patient to reach the optimal level of function for discharge	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 Outcome Measures

Name	Time	Method
6 minute walk test	visits 2 (Week 2) and 5 (Week 12) for both goups	Distance covered on a 6 minute walk
MRC (Medical Research Council) scale	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).
10 meter walk test	visits 2 (Week 2) and 5 (Week 12) for both goups	Time and speed in 10 meter walk
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)	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.
Knee flexion articular balance	Visits 1 (week 1) to 5 (week 12) for both groups	Knee flexion range of motion measured with a goniometer
TRAK platform knee flexion test	Visits 1 (week 1) to 5 (week 12) only on the intervention group	Knee flexion measured by video on the TRAK platform
Up and go test	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.
Stable gait assessment Y/N	visits 2 (Week 2) and 5 (Week 12) for both goups	Stable running or not depending on the professional's judgement
VAS scale	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
Kujala Score or Anterior Knee Pain Scale (AKPS) on the TRAK platform	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.
Functional Knee Scale KOOS-PS (Knee Injury and Osteoarthritis Outcome Score)	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.
Patient satisfaction survey on the use of the TRAK Platform	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.
EQ-5D-5L Questionnaire	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.

Trial Locations

Locations (1)

Cruces University Hospital (HU Cruces, OSI EEC); 🇪🇸 Baracaldo, País Vasco, Spain