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| Name | Class |
|---|---|
| Biokeralty Research Institute | INDUSTRY |
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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.
A parallel, controlled randomized clinical trial will be conducted. Study Population: Patients with knee osteoarthritis undergoing primary total knee replacement (TKR) at ClÃnica 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of therapy sessions | Number of face-to-face physical therapy sessions or TRAK therapy sessions. | From the beginning of rehabilitation until the third postoperative month. |
| Percentage of Adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Universitaria Colombia | Bogotá | Bogota D.C. | 111111 | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34195473 | Background | 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. | |
| 28934966 | Background |
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |
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Not provided
| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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|
| 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. |
|
Percentage of adherence to the prescribed rehabilitation program.
| From the beginning of rehabilitation until the third postoperative month. |
| Patient Satisfaction | 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 | Measured at the end of rehabilitation, 3 months postoperatively |
| Surgery Complications | Complications derived from the surgical procedure: Material Failure, Dislocation, Fracture, Wound Dehiscence, Rigidity, Readmission, Death, Need for mobilization under anesthesia | Measured from the start of surgery to the third month postoperatively. |
| Therapy Adverse Events | Adverse events that occurred during the prescribed therapy sessions: Fall, Wound Dehiscence, Fracture, Ecchymosis, Ligament Injury, Need for intervention, Hematoma, Other | Measured from the start of the postoperative period to the third postoperative month. |
| 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. |
| 18425906 | 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. |
| 25209014 | 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. |
| 28750967 | 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. |
| 30030037 | 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. |
| 33547927 | 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. |
| 34462184 | 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. |
| 28802773 | 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. |
| 28575058 | 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. |
| Background | Hsu H, Siwiec RM. Knee Osteoarthritis. StatPearls. Treasure Island (FL). 2024. Available from: https://www.ncbi.nlm.nih.gov/books/NBK507884/ |
| 28027679 | 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. |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |