Knee Injury, Shoulder Injury
Conditions
Keywords
Telemedicine, Digital health, Telehealth care
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.
Interventions
DEVICETrak-Physio knee condition
The exercise protocol designed for knee conditions is carried out through Trak, the digital rehabilitation tool.
DEVICETrak-Physio in shoulder condition
The exercise protocol designed for knee conditions is carried out through Trak, the digital rehabilitation tool.
Exercise protocol with the methodology of conventional clinical practice.
OTHERShoulder conventional rehabilitation program
Exercise protocol with the methodology of conventional clinical practice.
Sponsors
Trak Health Solutions S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Escala DASH | Baseline and six months | It is used to measure the self-rated upper-extremity disability and symptoms. |
| Escala KOOS-PS | Baseline and six months | It evaluates the patient's opinion about their knee and associated problems. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daniels scale | Baseline and six months | It is used to measure the patients strength on a specific movement and muscle from 0 to 5, being 0 a total paralysis and a 5 the full joint movement with a resistance. |
| EVA scale | Baseline and six months | It is used to measure the level of pain the patient feels. |
| Trak designed a satisfaction questionnaire | Baseline and six months | The trak satisfaction questionnaire was provided to patients in Spanish and consists of 12 questions about usability, usefulness and satisfaction as well as a suggestions section at the end. |
| Limb mobility | Baseline and six months | It will be measured with a goniometer. |
Countries
Spain
Outcome results
None listed