An interventional study of TRAK physio knee prosthesis protocol and Knee conventional rehabilitation program in Knee Arthropathy, sponsored by Trak Health Solutions S.L.. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Trak Health Solutions S.L. · Not applicable, Interventional, and Treatment
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:
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.
712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 470 interventional studies indexed under Joint Diseases.
Browse Joint Diseases studies →Trak Health Solutions S.L. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Combined treatment of conventional rehabilitation plus virtual telerehabilitation treatment with the TRAK Platform.
Other: TRAK physio knee prosthesis protocol · Other: Knee conventional rehabilitation program
Conventional face-to-face rehabilitation treatment.
Other: Knee conventional rehabilitation program
The exercise protocol designed for knee conditions is carried out through TRAK, the digital rehabilitation tool.
Exercise protocol with the methodology of conventional clinical practice.
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
Time frame: Visit 5 (week 12)
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.
Time frame: visits 1 (Week 1) and 5 (Week 12) for both goups
Knee flexion articular balance
Knee flexion range of motion measured with a goniometer
Time frame: Visits 1 (week 1) to 5 (week 12) for both groups
TRAK platform knee flexion test
Knee flexion measured by video on the TRAK platform
Time frame: Visits 1 (week 1) to 5 (week 12) only on the intervention group
MRC (Medical Research Council) scale
Strength test for the cuadriceps muscle. The results go from Grade 5 (normal) to Grade 0 (no visible contraction).
Time frame: Visits 1 (week 1) to 5 (week 12) for both groups
10 meter walk test
Time and speed in 10 meter walk
Time frame: visits 2 (Week 2) and 5 (Week 12) for both goups
6 minute walk test
Distance covered on a 6 minute walk
Time frame: visits 2 (Week 2) and 5 (Week 12) for both goups
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.
Time frame: visits 2 (Week 2) and 5 (Week 12) for both goups
Stable gait assessment Y/N
Stable running or not depending on the professional's judgement
Time frame: visits 2 (Week 2) and 5 (Week 12) for both goups
VAS scale
Scale used by the patient to measure pain from 1 to 10 being 1 no pain and 10 the highest pain posible
Time frame: visits 1 (week 1) to 5 (week 2) for both goups
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.
Time frame: visits 1 (week 1) and 5 (week 12) for both goups
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.
Time frame: visits 1 (week 1) to 5 (week 12) for both goups
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.
Time frame: Visit 5 (week 12) on the intervention group
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.
Time frame: visits 1 (week 1) and 5 (week 12) for both goups
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