Effectiveness of Telerehabilitation With Trak in Knee and Shoulder Pathology: A Randomized Clinical Trial (TRAK-TEST)

Trak Health Solutions S.L.

Status: Completed

Conditions: Knee Injury; Shoulder Injury

Treatments: Other: Knee conventional rehabilitation program; Device: Trak-Physio knee condition; Other: Shoulder conventional rehabilitation program; Device: Trak-Physio in shoulder condition

Study type: Interventional

Funder types: Industry

Identifiers

NCT06498453

TRAK-TEST

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient over 18 years of age.
• 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 advanced cognitive impairment.
• Patients with tendon tears or ruptures, in patients with shoulder tendinopathy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

Knee treatment

Experimental group

Description:

Use of TRAK platform as a treatment metodology on knee patients

Treatment:

Device: Trak-Physio knee condition

Knee control

Active Comparator group

Description:

They did not have access to the platform and were instructed to continue with the standard care program through exercise.

Treatment:

Other: Knee conventional rehabilitation program

Shoulder treatment

Experimental group

Description:

Use of TRAK platform as a treatment metodology on shoulder patients

Treatment:

Device: Trak-Physio in shoulder condition

Shoulder control

Active Comparator group

Description:

They did not have access to the platform and were instructed to continue with the standard care program through exercise.

Treatment:

Other: Shoulder conventional rehabilitation program