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Completed

NCT Number: NCT06735547

Effectiveness of a Mobile Telerehabilitation Tool Versus Conventional Treatment in Total Knee Arthroplasty

Knee arthroplasty is one of the most common surgical procedures, and early rehabilitation is essential for patient recovery, pain modulation and a faster reintegration into daily life activities. However, it has been reported that the percentage of patients who continue rehabilitation for the time required to achieve these outcomes is much lower than those who abandon therapy. This is often due to various factors such as office hours, difficult access to appointments, and sometimes insufficient infrastructure and personnel to meet the demand. Currently, due to the global situation, it is crucial to conduct these rehabilitation processes remotely and virtually, making use of various technological tools that enable patients to interact with the healthcare professionals in charge of their rehabilitation. Among these tools are mobile applications on smartphones, which not only facilitate proper physical preparation, but also offer valuable real-time feedback. Furthermore, 8% of the total cost of knee joint replacements corresponds to the rehabilitation program. These costs are significantly reduced with telerehabilitation assisted by mobile tools, which not only improves patient access but also increases adherence and satisfaction levels by allowing the customization of rehabilitation programs based on each patient's specific needs and characteristics. The aim of this study is to evaluate the effectiveness outcomes of an artificial intelligence-guided mobile tool versus conventional rehabilitation during the first three months postoperatively following total knee replacement.

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Key information

Conditions

Musculoskeletal Disorders Arthritis Joint Diseases Knee Osteoarthritis (OA) Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Universitaria Colombia

Bogotá, Bogota D.C., 111111, Colombia

About this study

A parallel, controlled randomized clinical trial will be conducted. Study Population: Patients with knee osteoarthritis undergoing primary total knee replacement (TKR) at Clínica Universitaria Colombia and Puente Aranda Emergency Center, whose postoperative follow-up is ambulatory, and who meets the inclusion criteria.

Outcomes: Functionality will be the primary outcome, measured in terms of the WOMAC score, knee range of movement, and pain, by means of the visual analogue scale. Adherence to treatment, number of therapy sessions, patient satisfaction, and the presence of adverse events will also be measured.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with degenerative osteoarthritis with an indication for primary Total Knee Replacement (TKR) surgery at Clínica Universitaria Colombia or Central de Urgencias de Puente Aranda.
  • Patients in the postoperative period following primary outpatient TKR.
  • Patients with functional independence.
  • Patients who agree to participate in the study and sign the informed consent form.
  • Patients with access to a mobile device, tablet, computer, with internet access and the ability to operate it.
  • Patients who have an appropriate space to perform therapy at home.
  • Patients who will be accompanied during therapy sessions at home.

Exclusion criteria

  • ASA Class IV (American Society of Anesthesiologists)
  • BMI > 35
  • Dementia and cognitive impairment

Treatment and study plan

Telerehabilitation

Device

Patients in the Telerehabilitation group will perform an average of three therapy sessions per week, with data collected and monitored by TRAK's physiotherapists. Both groups will have their results measured monthly by the orthopedic surgeons for 12 weeks (3 months) postoperatively.

Conventional therapy group

Other

Patients in the conventional group will be assessed by a professional physiotherapist, scheduling appointments according to their own preferences and disponibility. Both groups will have their results measured monthly by the orthopedic surgeons for 12 weeks (3 months) postoperatively.

Primary outcomes

  1. Knee Range of Motion

    Time frame: Measurement will be performed before surgery (at the preoperative visit) and monthly during the first three months of the postoperative period (ending at 3 months postoperatively).

    Measurement of knee joint range of motion in flexion and extension using a goniometer from preoperative follow-up to the third month postoperatively.

  2. Functionality - WOMAC survey

    Time frame: Measurement will be performed before surgery (at the preoperative visit) and monthly during the first three months of the postoperative period (ending at 3 months postoperatively).

    WOMAC survey, validated in Colombia with a numerical result from 0 to 96, carried out during the preoperative visit until the third postoperative month.

  3. Functionality - Get Up and Go

    Time frame: Measurement will be performed before surgery (at the preoperative visit) and monthly during the first three months of the postoperative period (ending at 3 months postoperatively).

    Test that measures the time required to get up from the chair, walk to the mark 3 meters away, turn around and sit back in the chair, measured from preoperative follow-up to the third month postoperatively.

  4. Pain - Visual Analogue Scale

    Time frame: Measured from day 0 every 24 hours until day 14 postoperatively.

    Measurement of the patient's subjective perception of pain in a written survey and scale from 0 to 10.

Secondary outcomes

  1. Number of therapy sessions

    Time frame: From the beginning of rehabilitation until the third postoperative month.

    Number of face-to-face physical therapy sessions or TRAK therapy sessions.

  2. Percentage of Adherence

    Time frame: From the beginning of rehabilitation until the third postoperative month.

    Percentage of adherence to the prescribed rehabilitation program.

  3. Patient Satisfaction

    Time frame: Measured at the end of rehabilitation, 3 months postoperatively

    Measuring patient satisfaction with the prescribed rehabilitation program through a question with the option to respond: completely satisfied, satisfied, neither satisfied nor dissatisfied, somewhat satisfied, and not at all satisfied

  4. Surgery Complications

    Time frame: Measured from the start of surgery to the third month postoperatively.

    Complications derived from the surgical procedure: Material Failure, Dislocation, Fracture, Wound Dehiscence, Rigidity, Readmission, Death, Need for mobilization under anesthesia

  5. Therapy Adverse Events

    Time frame: Measured from the start of the postoperative period to the third postoperative month.

    Adverse events that occurred during the prescribed therapy sessions: Fall, Wound Dehiscence, Fracture, Ecchymosis, Ligament Injury, Need for intervention, Hematoma, Other

Sponsors and collaborators

Lead sponsor

Sanitas University

Other

Collaborators

  • Biokeralty Research Institute

Registry information

Official study title

Effectiveness of a Mobile Telerehabilitation Tool Versus Conventional Treatment in Total Knee Arthroplasty: a Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 16, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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