Virtual Rehabilitation Platform for Patients With Knee Prothesis

December 2, 2024 updated by: Trak Health Solutions S.L.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • País Vasco
      • Baracaldo, País Vasco, Spain, 20018
        • Recruiting
        • Cruces University Hospital (HU Cruces, OSI EEC)
        • Contact:
        • Principal Investigator:
          • RAÚL ZABALLA FERNÁNDEZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRAK treatment group
Combined treatment of conventional rehabilitation plus virtual telerehabilitation treatment with the TRAK Platform.
Other: Knee conventional rehabilitation program
Exercise protocol with the methodology of conventional clinical practice.
Other: TRAK physio knee prosthesis protocol
The exercise protocol designed for knee conditions is carried out through TRAK, the digital rehabilitation tool.
Active Comparator: Knee control group
Conventional face-to-face rehabilitation treatment.
Other: Knee conventional rehabilitation program
Exercise protocol with the methodology of conventional clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Visit 5 (week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
visits 1 (Week 1) and 5 (Week 12) for both goups
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
Visits 1 (week 1) to 5 (week 12) for both groups
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
Visits 1 (week 1) to 5 (week 12) only on the intervention group
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).
Visits 1 (week 1) to 5 (week 12) for both groups
10 meter walk test
Time Frame: visits 2 (Week 2) and 5 (Week 12) for both goups
Time and speed in 10 meter walk
visits 2 (Week 2) and 5 (Week 12) for both goups
6 minute walk test
Time Frame: visits 2 (Week 2) and 5 (Week 12) for both goups
Distance covered on a 6 minute walk
visits 2 (Week 2) and 5 (Week 12) for both goups
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.
visits 2 (Week 2) and 5 (Week 12) for both goups
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
visits 2 (Week 2) and 5 (Week 12) for both goups
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
visits 1 (week 1) to 5 (week 2) for both goups
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.
visits 1 (week 1) and 5 (week 12) for both goups
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.
visits 1 (week 1) to 5 (week 12) for both goups
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.
Visit 5 (week 12) on the intervention group
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.
visits 1 (week 1) and 5 (week 12) for both goups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trak Health Solutions S.L.

Collaborators

Biocruces Bizkaia Health Research Institute

Investigators

  • Principal Investigator: RAÚL ZABALLA FERNÁNDEZ, Cruces University Hospital (HU Cruces)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2024

Primary Completion (Estimated)

June 5, 2025

Study Completion (Estimated)

July 5, 2025

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Estimated)

December 6, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRAK-CRUCES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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