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

NCT06735547 | Completed DMC

• 1 other identifier: 102-22UNV
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Musculoskeletal Disorders; Knee Osteoarthritis (OA)

Keywords

Knee replacement arthroplasty; Telerehabilitation; Mobile applications; Artificial intelligence; Outpatient management

Outcome Measures

Primary Outcomes (4)

• Knee Range of Motion

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

  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).

• Functionality - WOMAC survey

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

  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).

• Functionality - Get Up and Go

  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.

  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).

• Pain - Visual Analogue Scale

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

  Measured from day 0 every 24 hours until day 14 postoperatively.

Secondary Outcomes (5)

• Number of therapy sessions

  From the beginning of rehabilitation until the third postoperative month.

• Percentage of Adherence

  From the beginning of rehabilitation until the third postoperative month.

• Patient Satisfaction

  Measured at the end of rehabilitation, 3 months postoperatively

• Surgery Complications

  Measured from the start of surgery to the third month postoperatively.

• Therapy Adverse Events

  Measured from the start of the postoperative period to the third postoperative month.

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

Patients will receive telerehabilitation by means of the TRAK mobile tool, collecting data and allowing them to monitor their activity through ROM during exercises (bio-feedback).

Device: Telerehabilitation

Conventional Therapy

ACTIVE COMPARATOR

Patients will be assessed by a professional physiotherapist, who will monitor their progress, by measuring range of motion (ROM), and stability, making corrections if necessary.

Other: Conventional therapy group

Interventions

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.

Telerehabilitation

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.

Conventional Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sanitas University: lead
• Biokeralty Research Institute: collaborator

Study Sites (1)

Clínica Universitaria Colombia

Bogotá, Bogota D.C., 111111, Colombia

Location

Related Publications (12)

• Pellegrini CA, Lee J, DeVivo KE, Harpine CE, Del Gaizo DJ, Wilcox S. Reducing sedentary time using an innovative mHealth intervention among patients with total knee replacement: Rationale and study protocol. Contemp Clin Trials Commun. 2021 Jun 18;22:100810. doi: 10.1016/j.conctc.2021.100810. eCollection 2021 Jun.

  PMID: 34195473 BACKGROUND

• Eichler S, Rabe S, Salzwedel A, Muller S, Stoll J, Tilgner N, John M, Wegscheider K, Mayer F, Voller H; ReMove-It study group. Effectiveness of an interactive telerehabilitation system with home-based exercise training in patients after total hip or knee replacement: study protocol for a multicenter, superiority, no-blinded randomized controlled trial. Trials. 2017 Sep 21;18(1):438. doi: 10.1186/s13063-017-2173-3.

  PMID: 28934966 BACKGROUND

• Khan F, Ng L, Gonzalez S, Hale T, Turner-Stokes L. Multidisciplinary rehabilitation programmes following joint replacement at the hip and knee in chronic arthropathy. Cochrane Database Syst Rev. 2008 Apr 16;2008(2):CD004957. doi: 10.1002/14651858.CD004957.pub3.

  PMID: 18425906 BACKGROUND

• Muller M, Toussaint R, Kohlmann T. [Total hip and knee arthroplasty : Results of outpatient orthopedic rehabilitation]. Orthopade. 2015 Mar;44(3):203-11. doi: 10.1007/s00132-014-3000-0. German.

  PMID: 25209014 BACKGROUND

• Callejas-Cuervo M, Gutierrez RM, Hernandez AI. Joint amplitude MEMS based measurement platform for low cost and high accessibility telerehabilitation: Elbow case study. J Bodyw Mov Ther. 2017 Jul;21(3):574-581. doi: 10.1016/j.jbmt.2016.08.016. Epub 2016 Sep 9.

  PMID: 28750967 BACKGROUND

• van Egmond MA, van der Schaaf M, Vredeveld T, Vollenbroek-Hutten MMR, van Berge Henegouwen MI, Klinkenbijl JHG, Engelbert RHH. Effectiveness of physiotherapy with telerehabilitation in surgical patients: a systematic review and meta-analysis. Physiotherapy. 2018 Sep;104(3):277-298. doi: 10.1016/j.physio.2018.04.004. Epub 2018 Jun 19.

  PMID: 30030037 BACKGROUND

• Backer HC, Wu CH, Schulz MRG, Weber-Spickschen TS, Perka C, Hardt S. App-based rehabilitation program after total knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2021 Sep;141(9):1575-1582. doi: 10.1007/s00402-021-03789-0. Epub 2021 Feb 6.

  PMID: 33547927 BACKGROUND

• Tripuraneni KR, Foran JRH, Munson NR, Racca NE, Carothers JT. A Smartwatch Paired With A Mobile Application Provides Postoperative Self-Directed Rehabilitation Without Compromising Total Knee Arthroplasty Outcomes: A Randomized Controlled Trial. J Arthroplasty. 2021 Dec;36(12):3888-3893. doi: 10.1016/j.arth.2021.08.007. Epub 2021 Aug 9.

  PMID: 34462184 BACKGROUND

• Henderson KG, Wallis JA, Snowdon DA. Active physiotherapy interventions following total knee arthroplasty in the hospital and inpatient rehabilitation settings: a systematic review and meta-analysis. Physiotherapy. 2018 Mar;104(1):25-35. doi: 10.1016/j.physio.2017.01.002. Epub 2017 Feb 1.

  PMID: 28802773 BACKGROUND

• Masaracchio M, Hanney WJ, Liu X, Kolber M, Kirker K. Timing of rehabilitation on length of stay and cost in patients with hip or knee joint arthroplasty: A systematic review with meta-analysis. PLoS One. 2017 Jun 2;12(6):e0178295. doi: 10.1371/journal.pone.0178295. eCollection 2017.

  PMID: 28575058 BACKGROUND

• Hsu H, Siwiec RM. Knee Osteoarthritis. StatPearls. Treasure Island (FL). 2024. Available from: https://www.ncbi.nlm.nih.gov/books/NBK507884/

  BACKGROUND

• Jiang S, Xiang J, Gao X, Guo K, Liu B. The comparison of telerehabilitation and face-to-face rehabilitation after total knee arthroplasty: A systematic review and meta-analysis. J Telemed Telecare. 2018 May;24(4):257-262. doi: 10.1177/1357633X16686748. Epub 2016 Dec 27.

  PMID: 28027679 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases; Osteoarthritis, Knee

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director research unit

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: December 16, 2024
• Study Start: December 1, 2023
• Primary Completion: March 30, 2024
• Study Completion: October 10, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)