NCT06498453

Effectiveness of Telerehabilitation With Trak in Knee and Shoulder Pathology: A Randomized Clinical Trial

A Randomized Clinical Trial to Evaluate the Effectiveness of Telerehabilitation With Trak in Patients With Knee or Shoulder Pathology.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Trak Health Solutions S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this clinical trial is to compare the effectiveness of digital physiotherapy treatment using the Trak telerehabilitation platform and the application of conventional means on two different health conditions (mild or moderate knee osteoarthritis and shoulder tendinopathy) 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

The recruitment process for this study is aimed at adults who suffer from musculoskeletal pathologies of the knee (mild or moderate osteoarthritis) or shoulder (tendinopathy). 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

• Shoulder Injury
• Knee Injury

Interventions

Type	Name	Description
DEVICE	Trak-Physio knee condition	The exercise protocol designed for knee conditions is carried out through Trak, the digital rehabilitation tool.
DEVICE	Trak-Physio in shoulder condition	The exercise protocol designed for knee conditions is carried out through Trak, the digital rehabilitation tool.
OTHER	Knee conventional rehabilitation program	Exercise protocol with the methodology of conventional clinical practice.
OTHER	Shoulder conventional rehabilitation program	Exercise protocol with the methodology of conventional clinical practice.

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-06-06
• Completion: 2023-06-06
• First posted: 2024-07-12
• Last updated: 2024-12-03

Locations

1 site across 1 country: Spain