Virtual Rehabilitation Platform for Patients With Knee Prothesis
ConditionKnee Arthropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorTrak Health Solutions S.L.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
TRAK physio knee prosthesis protocol
Other interventionThe exercise protocol designed for knee conditions is carried out through TRAK, the digital rehabilitation tool.
Knee conventional rehabilitation program
Other interventionExercise protocol with the methodology of conventional clinical practice.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: TRAK treatment groupExperimental treatment 2 interventions
Group B: Knee control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
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
Time frame
Visit 5 (week 12)Secondary outcomes
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.
Time frame
visits 1 (Week 1) and 5 (Week 12) for both goups2
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 groups3
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 group4
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 groupsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Trak Health Solutions S.L.
Lead sponsor
Biobizkaia Health Research Institute
Collaborator
Source ClinicalTrials.gov