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Completed

NCT Number: NCT06498453

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asunción Klinika

Tolosa, Gipuzkoa, 20400, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trak-Physio knee condition

Device

The exercise protocol designed for knee conditions is carried out through Trak, the digital rehabilitation tool.

Trak-Physio in shoulder condition

Device

The exercise protocol designed for knee conditions is carried out through Trak, the digital rehabilitation tool.

Knee conventional rehabilitation program

Other

Exercise protocol with the methodology of conventional clinical practice.

Shoulder conventional rehabilitation program

Other

Exercise protocol with the methodology of conventional clinical practice.

Primary outcomes

  1. Escala DASH

    Time frame: Baseline and six months

    It is used to measure the self-rated upper-extremity disability and symptoms.

  2. Escala KOOS-PS

    Time frame: Baseline and six months

    It evaluates the patient's opinion about their knee and associated problems.

Secondary outcomes

  1. Daniels scale

    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.

  2. EVA scale

    Time frame: Baseline and six months

    It is used to measure the level of pain the patient feels.

  3. Trak designed a satisfaction questionnaire

    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.

  4. Limb mobility

    Time frame: Baseline and six months

    It will be measured with a goniometer.

Sponsors and collaborators

Lead sponsor

Trak Health Solutions S.L.

Industry

Registry information

Official study title

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

Acronym: TRAK-TEST

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2024
Registry last updated
Dec 3, 2024

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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