Effectiveness of Telerehabilitation With Trak in Knee and Shoulder Pathology: A Randomized Clinical Trial
NCT ID: NCT06498453
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-03-01
2023-06-06
Brief Summary
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Participants will undergo telerehabilitation treatment through the TRAK platform for six weeks (treatment group) or follow the instructions and guidelines collected by health personnel for the same time in face-to-face rehabilitation sessions (control group).
Detailed Description
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After the initial screening, individuals who meet the study's predefined inclusion criteria will be invited to participate. Before enrollment, written informed consent will be obtained from all participants, ensuring ethical compliance and respect for individual autonomy.
The study cohort will consist of patients randomly assigned to the experimental group (EG) and the control group (CG) on both knee and shoulder groups. This randomised controlled trial has a parallel design with two groups. Regardless of group assignment, all patients will undergo baseline health assessments, ensuring that their individual needs are met. The satisfaction questionnaire will be deferred until post-intervention for both groups.
Patients will undergo 4 weeks of treatment through the TRAK tool (https://www.trakphysio.com/es/). Patients from the EG will carry out the treatment through the platform at home, and those from the CG will follow an on paper exercise protocol based on the usual (in-person) clinical practice methodology. Both groups will perform exercises in these rehabilitation sessions to improve shoulder mobility.
In phase 1 (3 weeks), all groups will undergo two weeks of in-person treatment based on established drainage technique and TENS application, ensuring the treatment's safety and efficacy. In addition, the patients will begin with in-person (CG) or remote treatment (EG), depending on the case. In the second phase or phase 2 (3 more weeks), patients will perform the exercises at home (EG) or at the medical center (CG).
The results will be evaluated using different scales, such as the DASH scale and the KOOS-PS scale, as well as other secondary scales assessing strength, mobility, pain, and patient satisfaction. These measurements will be collected at the beginning and end of the proposed treatment. These scales will be completed on paper at the beginning and end of the study for both groups, although the daily scales (pain, mobility and strength) will be completed through the platform in the case of the treatment group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Knee treatment
Use of TRAK platform as a treatment metodology on knee patients
Trak-Physio knee condition
The exercise protocol designed for knee conditions is carried out through Trak, the digital rehabilitation tool.
Knee control
They did not have access to the platform and were instructed to continue with the standard care program through exercise.
Knee conventional rehabilitation program
Exercise protocol with the methodology of conventional clinical practice.
Shoulder treatment
Use of TRAK platform as a treatment metodology on shoulder patients
Trak-Physio in shoulder condition
The exercise protocol designed for knee conditions is carried out through Trak, the digital rehabilitation tool.
Shoulder control
They did not have access to the platform and were instructed to continue with the standard care program through exercise.
Shoulder conventional rehabilitation program
Exercise protocol with the methodology of conventional clinical practice.
Interventions
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Trak-Physio knee condition
The exercise protocol designed for knee conditions is carried out through Trak, the digital rehabilitation tool.
Trak-Physio in shoulder condition
The exercise protocol designed for knee conditions is carried out through Trak, the digital rehabilitation tool.
Knee conventional rehabilitation program
Exercise protocol with the methodology of conventional clinical practice.
Shoulder conventional rehabilitation program
Exercise protocol with the methodology of conventional clinical practice.
Eligibility Criteria
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Inclusion Criteria
* Patients with musculoskeletal pathology according to:
Knee: patients between 50 and 70 years old with a knee injury. Among the injuries Considered include mild or moderate osteoarthrosis and knee meniscopathies.
Shoulder: patients with shoulder tendonitis.
* Patients with a tablet, smartphone or laptop who function agilely with the telematic technology necessary for the study.
* Have an email account.
* Understand the purpose of the study.
* Signing of the informed consent.
* Commitment to carry out the prescribed treatments.
Exclusion Criteria
* Patients with tendon tears or ruptures, in patients with shoulder tendinopathy.
18 Years
ALL
No
Sponsors
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Trak Health Solutions S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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María A García Velázquez
Role: PRINCIPAL_INVESTIGATOR
Asunción Klinika
Locations
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Asunción Klinika
Tolosa, Gipuzkoa, Spain
Countries
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References
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Anton D, Berges I, Bermudez J, Goni A, Illarramendi A. A Telerehabilitation System for the Selection, Evaluation and Remote Management of Therapies. Sensors (Basel). 2018 May 8;18(5):1459. doi: 10.3390/s18051459.
Chae SH, Kim Y, Lee KS, Park HS. Development and Clinical Evaluation of a Web-Based Upper Limb Home Rehabilitation System Using a Smartwatch and Machine Learning Model for Chronic Stroke Survivors: Prospective Comparative Study. JMIR Mhealth Uhealth. 2020 Jul 9;8(7):e17216. doi: 10.2196/17216.
Cottrell MA, Hill AJ, O'Leary SP, Raymer ME, Russell TG. Service provider perceptions of telerehabilitation as an additional service delivery option within an Australian neurosurgical and orthopaedic physiotherapy screening clinic: A qualitative study. Musculoskelet Sci Pract. 2017 Dec;32:7-16. doi: 10.1016/j.msksp.2017.07.008. Epub 2017 Aug 1.
Cramer SC, Dodakian L, Le V, See J, Augsburger R, McKenzie A, Zhou RJ, Chiu NL, Heckhausen J, Cassidy JM, Scacchi W, Smith MT, Barrett AM, Knutson J, Edwards D, Putrino D, Agrawal K, Ngo K, Roth EJ, Tirschwell DL, Woodbury ML, Zafonte R, Zhao W, Spilker J, Wolf SL, Broderick JP, Janis S; National Institutes of Health StrokeNet Telerehab Investigators. Efficacy of Home-Based Telerehabilitation vs In-Clinic Therapy for Adults After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Sep 1;76(9):1079-1087. doi: 10.1001/jamaneurol.2019.1604.
Hosseiniravandi M, Kahlaee AH, Karim H, Ghamkhar L, Safdari R. Home-based telerehabilitation software systems for remote supervising: a systematic review. Int J Technol Assess Health Care. 2020 Apr;36(2):113-125. doi: 10.1017/S0266462320000021. Epub 2020 Mar 10.
Hung M, Bounsanga J, Voss MW, Saltzman CL. Establishing minimum clinically important difference values for the Patient-Reported Outcomes Measurement Information System Physical Function, hip disability and osteoarthritis outcome score for joint reconstruction, and knee injury and osteoarthritis outcome score for joint reconstruction in orthopaedics. World J Orthop. 2018 Mar 18;9(3):41-49. doi: 10.5312/wjo.v9.i3.41. eCollection 2018 Mar 18.
Monticone M, Baiardi P, Vanti C, Ferrari S, Pillastrini P, Mugnai R, Foti C. Responsiveness of the Oswestry Disability Index and the Roland Morris Disability Questionnaire in Italian subjects with sub-acute and chronic low back pain. Eur Spine J. 2012 Jan;21(1):122-9. doi: 10.1007/s00586-011-1959-3. Epub 2011 Aug 8.
Perruccio AV, Stefan Lohmander L, Canizares M, Tennant A, Hawker GA, Conaghan PG, Roos EM, Jordan JM, Maillefert JF, Dougados M, Davis AM. The development of a short measure of physical function for knee OA KOOS-Physical Function Shortform (KOOS-PS) - an OARSI/OMERACT initiative. Osteoarthritis Cartilage. 2008 May;16(5):542-50. doi: 10.1016/j.joca.2007.12.014. Epub 2008 Feb 21.
Seron P, Oliveros MJ, Gutierrez-Arias R, Fuentes-Aspe R, Torres-Castro RC, Merino-Osorio C, Nahuelhual P, Inostroza J, Jalil Y, Solano R, Marzuca-Nassr GN, Aguilera-Eguia R, Lavados-Romo P, Soto-Rodriguez FJ, Sabelle C, Villarroel-Silva G, Gomolan P, Huaiquilaf S, Sanchez P. Effectiveness of Telerehabilitation in Physical Therapy: A Rapid Overview. Phys Ther. 2021 Jun 1;101(6):pzab053. doi: 10.1093/ptj/pzab053.
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.
Other Identifiers
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TRAK-TEST
Identifier Type: -
Identifier Source: org_study_id