Use of the Efisiotrack System for Monitoring Patients With Shoulder Orthopedic Injuries

September 1, 2023 updated by: JOSE VICENTE TOLEDO MARHUENDA, Universidad Miguel Hernandez de Elche

Use of the Efisiotrack System for Monitoring Prescribed Therapeutic Exercises in Patients With Shoulder Orthopedic Injuries in a Hospital Setting: a Pilot Feasibility Study

To evaluate the effect on clinical variables of monitoring exercises prescribed for shoulder injury rehabilitation with the eFisioTrack platform in patients of the Rehabilitation Service at University Hospital of Elche.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients who be referred to the rehabilitation service of the University Hospital of Elche (Spain) for physiotherapy treatment (manual therapy, exercise, stretching, and electrotherapy) after suffering orthopedic injury or surgery in the shoulder joint complex will be considered for enrollment in the study.

Patients will performed the prescribed physical therapy treatment, at least three times per week in sessions of 45 minutes in the hospital setting (application of manual therapy and physical modalities as ultrasound, heat/cold, laser, magnetic field therapy) together with completion of the exercise program for functional recovery of the upper extremity (exercises for muscle strength, scapular stability, joint mobility, and proprioception).

Following baseline examination, patients will be randomly assigned to either physiotherapist-supervised exercise (control group) or monitoring by the eFisioTrack system (experimental group) to perform active exercises as part of their shoulder rehabilitation. These will be performed independently by each patient in a hospital room without supervision by the physiotherapist.

The following patient-reported outcome measures will be used to assess participants' shoulder pain and function: the Disabilities of Arm, Shoulder and Hand (DASH) score and the Constant-Murley (CM) score.

All participants will be assessed at baseline on their first visit to the physical therapy area and at one-month follow-up.

Study Type

Interventional

Enrollment (Estimated)

10

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 Contact

  • Name: Jose-Vicente Toledo-Marhuenda, PhD.
  • Phone Number: 9260 965 91 92 60
  • Email: josetoledo@umh.es

Study Contact Backup

  • Name: Sergio Hernández-Sánchez, PhD
  • Phone Number: 2548 965 91 25 48
  • Email: sehesa@umh.es

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Recruiting
        • Hospital General of Elche
        • Contact:
          • Jorge Roses Conde, Ph
          • Phone Number: 6900 966 61 69 00
          • Email: jroses@umh.es

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:

  • Be at least 18 years old and be able to read and understand Spanish.
  • Suffer a traumatic or degenerative shoulder injury, with or without surgical treatment.
  • Have a prescription for rehabilitative physical therapy that includes active exercises.

Exclusion Criteria:

-Had a concomitant injury on an upper extremity or the cervical spine at the time of participation or sequelae of previous injuries in the area.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: eFisioTrack Group

Use of the eFisioTrack platform in the experimental group to perform active exercises as part of their shoulder rehabilitation. These will. bee performed independently by each patient in a hospital room, using the efisioTrack system without supervision by the physiotherapist.

The subjects will be previously instructed in the use of the system in two 20-minute sessions. The type of exercise and its parameters will be chosen and progressed considering the functional status of the patient and being similar to those executed under the physiotherapist's supervision.
Procedure: eFisioTrack Group
Application of manual therapy and physical modalities together with completion of the exercise program for functional recovery of the upper extremity using the efisioTrack system without supervision by the physiotherapist.
Active Comparator: Excercises Group
Patients who performed the exercise program supervised by the physical physiotherapist in a hospital room.
Procedure: Excercises Group
Application of manual therapy and physical modalities together with completion of the exercise program for functional recovery of the upper extremity supervised by the physical physiotherapist in a hospital room.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disabilities of Arm, Shoulder and Hand (DASH) score
Time Frame: At baseline and at one month follow-up.
DASH - Measures symptoms and degree of function related to a disorder in the upper extremity. The DASH Outcome Measure is scored in two components: the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5). At least 27 of the 30 items must be completed for a score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a score out of five. This value is then transformed to a score out of 100 by subtracting one and multiplying by 25. This transformation is done to make the score easier to compare to other measures scaled on a 0-100 scale. A higher score indicates greater disability.
At baseline and at one month follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant-Murley (CM) score.
Time Frame: At baseline and at one month follow-up.
CMS - specific instrument for assessing the shoulder joint: pain; ability to perform daily activities; mobility and strength. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
At baseline and at one month follow-up.

Collaborators and Investigators

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

Sponsor

Universidad Miguel Hernandez de Elche

Collaborators

Hospital General Universitario Elche

Investigators

  • Study Director: Jorge Roses Conde, Ph, Hospital Generalof Elche

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)

June 29, 2023

Primary Completion (Actual)

August 30, 2023

Study Completion (Estimated)

September 30, 2023

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

September 1, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JVT002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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