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

December 2, 2024 updated by: Trak Health Solutions S.L.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Gipuzkoa
      • Tolosa, Gipuzkoa, Spain, 20400
        • Asunción Klinika

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Knee treatment
Use of TRAK platform as a treatment metodology on knee patients
Device: Trak-Physio knee condition
The exercise protocol designed for knee conditions is carried out through Trak, the digital rehabilitation tool.
Active Comparator: Knee control
They did not have access to the platform and were instructed to continue with the standard care program through exercise.
Other: Knee conventional rehabilitation program
Exercise protocol with the methodology of conventional clinical practice.
Experimental: Shoulder treatment
Use of TRAK platform as a treatment metodology on shoulder patients
Device: Trak-Physio in shoulder condition
The exercise protocol designed for knee conditions is carried out through Trak, the digital rehabilitation tool.
Active Comparator: Shoulder control
They did not have access to the platform and were instructed to continue with the standard care program through exercise.
Other: Shoulder conventional rehabilitation program
Exercise protocol with the methodology of conventional clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Escala DASH
Time Frame: Baseline and six months
It is used to measure the self-rated upper-extremity disability and symptoms.
Baseline and six months
Escala KOOS-PS
Time Frame: Baseline and six months
It evaluates the patient's opinion about their knee and associated problems.
Baseline and six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and six months
EVA scale
Time Frame: Baseline and six months
It is used to measure the level of pain the patient feels.
Baseline and six months
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.
Baseline and six months
Limb mobility
Time Frame: Baseline and six months
It will be measured with a goniometer.
Baseline and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trak Health Solutions S.L.

Investigators

  • Principal Investigator: María A García Velázquez, Asunción Klinika

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

June 6, 2023

Study Completion (Actual)

June 6, 2023

Study Registration Dates

First Submitted

July 5, 2024

First Submitted That Met QC Criteria

July 5, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRAK-TEST

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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