Asunción Klinika
Tolosa, Gipuzkoa, 20400, Spain
NCT Number: NCT06498453
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Tolosa, Gipuzkoa, 20400, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
The exercise protocol designed for knee conditions is carried out through Trak, the digital rehabilitation tool.
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.
Exercise protocol with the methodology of conventional clinical practice.
Time frame: Baseline and six months
It is used to measure the self-rated upper-extremity disability and symptoms.
Time frame: Baseline and six months
It evaluates the patient's opinion about their knee and associated problems.
Time frame: 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.
Time frame: Baseline and six months
It is used to measure the level of pain the patient feels.
Time frame: 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.
Time frame: Baseline and six months
It will be measured with a goniometer.
Trak Health Solutions S.L.
Industry
A Randomized Clinical Trial to Evaluate the Effectiveness of Telerehabilitation With Trak in Patients With Knee or Shoulder Pathology.
Acronym: TRAK-TEST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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