MedDataX Logo

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

NCT ID: NCT06735547

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-10-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Musculoskeletal Disorders Knee Osteoarthritis (OA)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Knee replacement arthroplasty Telerehabilitation Mobile applications Artificial intelligence Outpatient management

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Telerehabilitation

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).

Group Type EXPERIMENTAL

Telerehabilitation

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Conventional therapy group

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Telerehabilitation

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.

Intervention Type DEVICE

Conventional therapy group

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Biokeralty Research Institute

INDUSTRY

Sponsor Role collaborator

Sanitas University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Claudia Aristizábal

Director research unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clínica Universitaria Colombia

Bogotá, Bogota D.C., Colombia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Colombia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 34195473 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28934966 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18425906 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25209014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28750967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30030037 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33547927 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34462184 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28802773 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28575058 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 28027679 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

102-22UNV

Identifier Type: -

Identifier Source: org_study_id