Clinical trial NCT06498453: Effectiveness of Telerehabilitation With Trak in Knee and Shoulder Pathology: A Randomized Clinical Trial
Official title: A Randomized Clinical Trial to Evaluate the Effectiveness of Telerehabilitation With Trak in Patients With Knee or Shoulder Pathology.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Injury
Knee Injury
Keywords: Telemedicine
Digital health
Telehealth care
Lead sponsor: Trak Health Solutions S.L.
Sponsor class: INDUSTRY
First posted: 2024-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Escala DASH
timeFrame: Baseline and six months
measure: Escala KOOS-PS
timeFrame: Baseline and six months
Secondary outcomes:
measure: Daniels scale
timeFrame: Baseline and six months
measure: EVA scale
timeFrame: Baseline and six months
measure: Trak designed a satisfaction questionnaire
timeFrame: Baseline and six months
measure: Limb mobility
timeFrame: Baseline and six months
Other outcomes:
Locations:
city: Tolosa
country: Spain
facility: Asunción Klinika
state: Gipuzkoa
Study officials:
affiliation: Asunción Klinika
name: María A García Velázquez
role: PRINCIPAL_INVESTIGATOR
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